Trial Outcomes & Findings for A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347 (NCT NCT03275740)
NCT ID: NCT03275740
Last Updated: 2024-07-05
Results Overview
Adverse event (AE) was any untoward medical occurrence in the participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Serious AE was any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or was considered to be an important medical event. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent. AEs included both serious and non-serious AEs.
TERMINATED
PHASE1
58 participants
Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
2024-07-05
Participant Flow
The study planned 14 cohorts, however, it was terminated due to non-safety reasons during Cohort 11, with no further enrollment. Included in this study were all healthy participants, who were randomized to either receive PF-06755347 or placebo by intravenous (IV) or subcutaneous (SC) administration in a 3:1 allocation ratio. A total of 58 participants were dosed in this study: 42 received PF-06755347 and 16 received placebo.
Participant milestones
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
6
|
6
|
6
|
3
|
16
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
2
|
2
|
3
|
6
|
5
|
5
|
3
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
due to coronaviras disease 2019 (COVID-19) pandemic
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
Baseline Characteristics
A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347
Baseline characteristics by cohort
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
n=3 Participants
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
n=3 Participants
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
n=16 Participants
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18-25 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
15 Participants
n=36 Participants
|
|
Age, Customized
26-35 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
17 Participants
n=36 Participants
|
|
Age, Customized
36-45 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
14 Participants
n=36 Participants
|
|
Age, Customized
46-55 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
12 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
58 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
54 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
52 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).Population: All participants who received at least 1 dose of study medication.
Adverse event (AE) was any untoward medical occurrence in the participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Serious AE was any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or was considered to be an important medical event. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent. AEs included both serious and non-serious AEs.
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
n=3 Participants
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
n=3 Participants
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
n=16 Participants
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs
Serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs
Treatment-related TEAEs
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
3 Participants
|
7 Participants
|
|
Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs
Discontinuations from study due to TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs
All-causality TEAEs
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
3 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Baseline, Study Days 1, 2, 4, 6, 8, 11, 15, 22, 29 and 36 for IV treatment cohorts, and Baseline, Study Days 1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 50 and 71 for SC treatment cohorts.Population: All participants who received at least 1 dose of study medication.
Laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, absolute and percent total neutrophils, eosinophils, monocytes, basophils and lymphocytes),chemistry (blood urea nitrogen/urea and creatinine, fasting glucose, calcium, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin and total protein),urinalysis(pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy, urinary albumin to creatinine ratio and urinary protein to creatinine ratio) and other tests. Abnormality was determined by the investigator. Only lab abnormalities with at least 1 occurrence in participants are reported.
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
n=3 Participants
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
n=3 Participants
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
n=16 Participants
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities
Mean Platelet Volume > 1.1 x upper limit of normal (ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Ery. Mean Corpuscular Volume <0.9 x lower limit of normal (LLN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Ery. Mean Corpuscular Hemoglobin < 0.9 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Neutrophils >1.2 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Eosinophils/Leukocytes >1.2 x ULN
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Bilirubin >1.5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Aspartate Aminotransferase >3.0 x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Creatine Kinase >2.0 x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
C Reactive Protein >1.1 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Bicarbonate >1.1 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
D-Dimer >1.5 x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Specific Gravity <1.003
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Ketones ≥1
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
URINE Protein ≥1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
URINE Hemoglobin ≥1
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Urobilinogen ≥1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Leukocytes <0.6 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Lymphocytes <0.8 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Neutrophils <0.8 x LLN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Lymphocytes/ Leukocytes >1.2 x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Eosinophils >1.2 x ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Monocytes >1.2 x ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Monocytes/Leukocytes >1.2 x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Direct Bilirubin >1.5 x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Urea >1.3 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Urate >1.2 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Fibrinogen >1.25 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Specific Gravity >1.030
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
pH >8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
URINE Bilirubin ≥1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Nitrite ≥1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Leukocyte Esterase ≥1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline, Study Days 1, 2, 4, 6, 8, 11, 15, 22, 29 and 36 for IV treatment cohorts, and Baseline, Study Days 1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 50 and 71 for SC treatment cohorts.Population: All participants who received at least 1 dose of study medication.
Supine blood pressure and pulse rate were measured. Categorical classes for vital signs of potential clinical concerns were defined as followed: systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); diastolic blood pressure (DBP) \<50 mmHg; pulse rate \<40 beats per minute (bpm); pulse rate \>120 bpm, and increase from baseline in SBP ≥30 mmHg; decrease from baseline in SBP ≥30 mmHg; increase from baseline in DBP ≥20 mmHg; decrease from baseline in DBP ≥20 mmHg. Baseline was defined as the mean of the replicated predose (0 hour) measurement on Day 1.
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
n=3 Participants
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
n=3 Participants
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
n=16 Participants
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs Meeting Categorical Criteria
Pulse rate >120 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Meeting Categorical Criteria
DBP: increase from baseline ≥20 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Meeting Categorical Criteria
DBP: decrease from baseline ≥20 mmHg
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Meeting Categorical Criteria
SBP <90 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Meeting Categorical Criteria
SBP: increase from baseline ≥30 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Meeting Categorical Criteria
SBP: decrease from baseline ≥30 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Meeting Categorical Criteria
Pulse rate <40 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Meeting Categorical Criteria
DBP <50 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline (Study Day 1, predose), Study Days 1 (postdose), 2, 4, 6, 8, 11, 22, 36 (end of study visit for IV treatment cohorts) and 71 (end of study visit for SC treatment cohorts).Population: All participants who received at least 1 dose of study medication.
Number of participants with ECG findings meeting the following criteria: time between the onset of atrial depolarization and onset of ventricular depolarization (PR interval) ≥300 msec; time from ECG Q-wave to the end of the S wave corresponding to ventricular depolarization (QRS duration) ≥140 msec; correct time from ECG Q-wave to the end of the T wave corresponding to electrical systole for heart rate using Fridericia's formula (QTcF interval): ≥450 to \<480 msec; QTcF interval ≥480 to \<500 msec; QTcF interval: ≥500 msec; PR interval percent change from baseline (≥25/50%): ≥25% if baseline \>200 msec or ≥ 50% if baseline ≤200 msec; QRS duration percent change from baseline ≥50%; QTcF interval change from baseline: \>30 to ≤60 msec; QTcF interval change from baseline \>60 msec. Baseline was defined as the average of the triplicate predose recordings collected at 0 hour on Day 1.
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
n=3 Participants
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
n=3 Participants
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
n=16 Participants
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria
PR interval: percent change from baseline ≥25/50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria
QRS duration ≥140 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria
QRS duration: percent change from baseline ≥50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria
QTcF interval: ≥450 to <480 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria
QTcF interval: ≥480 to <500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria
QTcF interval ≥500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria
PR interval ≥300 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria
QTcF interval change from baseline: >30 msec to ≤60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria
QTcF interval change from baseline: >60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
Cmax was the highest concentration observed directly from data
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of PF-06755347 Following Single IV Dose
|
0.1123 micrograms/milliliter (ug/mL)
Geometric Coefficient of Variation 18
|
0.4462 micrograms/milliliter (ug/mL)
Geometric Coefficient of Variation 20
|
1.654 micrograms/milliliter (ug/mL)
Geometric Coefficient of Variation 10
|
4.700 micrograms/milliliter (ug/mL)
Geometric Coefficient of Variation 9
|
24.72 micrograms/milliliter (ug/mL)
Geometric Coefficient of Variation 21
|
12.36 micrograms/milliliter (ug/mL)
Geometric Coefficient of Variation 9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
Cmax was the highest concentration observed directly from data
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=6 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=6 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=6 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of PF-06755347 Following Single SC Dose
|
0.8946 ug/mL
Geometric Coefficient of Variation 25
|
1.374 ug/mL
Geometric Coefficient of Variation 68
|
2.641 ug/mL
Geometric Coefficient of Variation 40
|
5.678 ug/mL
Geometric Coefficient of Variation 15
|
5.276 ug/mL
Geometric Coefficient of Variation 47
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
Cmax(dn) = Cmax/Dose
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Normalized Cmax (Cmax(dn)) of PF-06755347 Following Single IV Dose
|
11.23 ug/mL/(miligrams/kilogram [mg/kg])
Geometric Coefficient of Variation 18
|
14.88 ug/mL/(miligrams/kilogram [mg/kg])
Geometric Coefficient of Variation 20
|
16.54 ug/mL/(miligrams/kilogram [mg/kg])
Geometric Coefficient of Variation 10
|
15.69 ug/mL/(miligrams/kilogram [mg/kg])
Geometric Coefficient of Variation 9
|
24.72 ug/mL/(miligrams/kilogram [mg/kg])
Geometric Coefficient of Variation 21
|
17.68 ug/mL/(miligrams/kilogram [mg/kg])
Geometric Coefficient of Variation 9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
Cmax(dn) = Cmax/Dose
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=6 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=6 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=6 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax(dn) of PF-06755347 Following Single SC Dose
|
0.03579 ug/mL/(mg/kg)
Geometric Coefficient of Variation 25
|
0.02748 ug/mL/(mg/kg)
Geometric Coefficient of Variation 68
|
0.02641 ug/mL/(mg/kg)
Geometric Coefficient of Variation 40
|
0.02842 ug/mL/(mg/kg)
Geometric Coefficient of Variation 15
|
5.276 ug/mL/(mg/kg)
Geometric Coefficient of Variation 0.01758
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
Tmax was the time to reach maximum observed plasma concentration, which was observed directly from data as time of first occurrence.
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time for Cmax (Tmax) of PF-06755347 Following Single IV Dose
|
1.270 hours
Interval 1.22 to 1.3
|
1.050 hours
Interval 1.05 to 1.08
|
1.180 hours
Interval 1.17 to 1.18
|
1.180 hours
Interval 1.18 to 1.18
|
1.170 hours
Interval 1.17 to 3.3
|
3.020 hours
Interval 1.0 to 3.03
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
Tmax was the time to reach maximum observed plasma concentration, which was observed directly from data as time of first occurrence.
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=6 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=6 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=6 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax of PF-06755347 Following Single SC Dose
|
48.00 hours
Interval 48.0 to 72.0
|
48.00 hours
Interval 48.0 to 48.9
|
60.05 hours
Interval 48.0 to 96.0
|
48.00 hours
Interval 24.0 to 96.0
|
72.00 hours
Interval 48.0 to 120.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
AUClast was determined using linear/Log trapezoidal method
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06755347 Following Single IV Dose
|
1.395 micrograms*hour/milliliter (ug*hr/mL)
Geometric Coefficient of Variation 70
|
10.51 micrograms*hour/milliliter (ug*hr/mL)
Geometric Coefficient of Variation 30
|
45.18 micrograms*hour/milliliter (ug*hr/mL)
Geometric Coefficient of Variation 9
|
156.4 micrograms*hour/milliliter (ug*hr/mL)
Geometric Coefficient of Variation 7
|
511.8 micrograms*hour/milliliter (ug*hr/mL)
Geometric Coefficient of Variation 29
|
316.2 micrograms*hour/milliliter (ug*hr/mL)
Geometric Coefficient of Variation 3
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.Population: All randomized participants who received at least one dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
AUClast was determined using linear/Log trapezoidal method
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=6 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=6 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=6 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUClast of PF-06755347 Following Single SC Dose
|
125.4 ug*hr/mL
Geometric Coefficient of Variation 12
|
230.2 ug*hr/mL
Geometric Coefficient of Variation 42
|
428.7 ug*hr/mL
Geometric Coefficient of Variation 24
|
859.5 ug*hr/mL
Geometric Coefficient of Variation 13
|
977.6 ug*hr/mL
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
AUClast(dn) = AUClast/Dose
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Normalized AUClast (AUClast(dn)) of PF-06755347 Following Single IV Dose
|
139.5 ug*hr/mL/(mg/kg)
Geometric Coefficient of Variation 70
|
349.8 ug*hr/mL/(mg/kg)
Geometric Coefficient of Variation 30
|
451.8 ug*hr/mL/(mg/kg)
Geometric Coefficient of Variation 9
|
521.1 ug*hr/mL/(mg/kg)
Geometric Coefficient of Variation 7
|
511.8 ug*hr/mL/(mg/kg)
Geometric Coefficient of Variation 29
|
451.8 ug*hr/mL/(mg/kg)
Geometric Coefficient of Variation 3
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
AUClast(dn) = AUClast/Dose
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=6 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=6 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=6 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUClast(dn) of PF-06755347 Following Single SC Dose
|
5.010 ug*hr/mL/(mg/kg)
Geometric Coefficient of Variation 13
|
4.603 ug*hr/mL/(mg/kg)
Geometric Coefficient of Variation 42
|
4.287 ug*hr/mL/(mg/kg)
Geometric Coefficient of Variation 24
|
4.297 ug*hr/mL/(mg/kg)
Geometric Coefficient of Variation 13
|
3.263 ug*hr/mL/(mg/kg)
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.Population: All randomized participants who received at least one dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
n=2 Participants
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06755347 Following Single IV Dose
|
—
|
12.52 ug*hr/mL
Geometric Coefficient of Variation 25
|
49.35 ug*hr/mL
Geometric Coefficient of Variation 10
|
162.7 ug*hr/mL
Geometric Coefficient of Variation 8
|
569.7 ug*hr/mL
Geometric Coefficient of Variation 29
|
NA ug*hr/mL
Geometric Coefficient of Variation NA
Geo mean was not calculated due to \<3 contributes.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.Population: All randomized participants who received at least one dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=5 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=6 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=5 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUCinf of PF-06755347 Following Single SC Dose
|
133.2 ug*hr/mL
Geometric Coefficient of Variation 10
|
234.7 ug*hr/mL
Geometric Coefficient of Variation 42
|
440.1 ug*hr/mL
Geometric Coefficient of Variation 25
|
861.3 ug*hr/mL
Geometric Coefficient of Variation 15
|
988.8 ug*hr/mL
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
AUCinf(dn) = AUCinf/Dose
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
n=2 Participants
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Normalized AUCinf (AUCinf(dn)) of PF-06755347 Following Single IV Dose
|
—
|
417.5 ug*hr/mL/mg
Geometric Coefficient of Variation 25
|
493.5 ug*hr/mL/mg
Geometric Coefficient of Variation 10
|
541.9 ug*hr/mL/mg
Geometric Coefficient of Variation 8
|
569.7 ug*hr/mL/mg
Geometric Coefficient of Variation 29
|
NA ug*hr/mL/mg
Geometric Coefficient of Variation NA
Geo mean was not calculated due to \<3 contributes.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
AUCinf(dn) = AUCinf/Dose
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=5 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=6 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=5 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUCinf(dn) of PF-06755347 Following Single SC Dose
|
5.323 ug*hr/mL/mg
Geometric Coefficient of Variation 11
|
4.695 ug*hr/mL/mg
Geometric Coefficient of Variation 42
|
4.401 ug*hr/mL/mg
Geometric Coefficient of Variation 25
|
4.305 ug*hr/mL/mg
Geometric Coefficient of Variation 15
|
3.295 ug*hr/mL/mg
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.Population: All randomized participants who received at least one dose and had at least 1 of the PK parameters of interest. All randomized participants who received at least one dose and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t½ = Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
n=2 Participants
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Half-life (t½) of PF-06755347 Following Single IV Dose
|
—
|
34.20 hours
Standard Deviation 7.3082
|
51.10 hours
Standard Deviation 4.7624
|
77.17 hours
Standard Deviation 0.40415
|
70.90 hours
Standard Deviation 12.150
|
NA hours
Standard Deviation NA
Geo mean was not calculated due to \<3 contributes.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.Population: All randomized participants who received at least one dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t½ = Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=5 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=6 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=5 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
t½ of PF-06755347 Following Single SC Dose
|
94.13 hours
Standard Deviation 32.843
|
135.6 hours
Standard Deviation 56.409
|
82.88 hours
Standard Deviation 19.498
|
100.1 hours
Standard Deviation 18.940
|
139.3 hours
Standard Deviation 9.8658
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
CL = Dose/AUCinf Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of study drug.
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
n=2 Participants
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Clearance (CL) of PF-06755347 Following Single IV Dose
|
—
|
0.002397 L/hr/kg
Geometric Coefficient of Variation 25
|
0.002027 L/hr/kg
Geometric Coefficient of Variation 10
|
0.001846 L/hr/kg
Geometric Coefficient of Variation 8
|
0.001758 L/hr/kg
Geometric Coefficient of Variation 29
|
NA L/hr/kg
Geometric Coefficient of Variation NA
Geo mean was not calculated due to \<3 contributes.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
CL/F = Dose/AUCinf Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=5 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=6 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=5 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of PF-06755347 Following Single SC Dose
|
0.1876 L/hr
Geometric Coefficient of Variation 11
|
0.2128 L/hr
Geometric Coefficient of Variation 42
|
0.2272 L/hr
Geometric Coefficient of Variation 25
|
0.2321 L/hr
Geometric Coefficient of Variation 15
|
0.3036 L/hr
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Study Days 8, 15, and 36 for all treatment cohorts plus Day 71 for SC treatment cohortsPopulation: All participants who received at least 1 dose of study medication. Number of participants analyzed represents the total number of participants in each treatment group in the analysis population for this outcome measure. Number analyzed represents the number of participants who had reportable results for this outcome measure.
Human serum samples were analyzed for the presence or absence of anti-PF-06755347 antibodies (ADA) following a tiered approach of screening, confirmation and titer determination, using an electrochemiluminescent (ECL) immunoassay. Baseline was the measurement on Day -1.
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
n=3 Participants
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
n=3 Participants
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
n=16 Participants
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Anti-Drug Antibody to PF-06755347
Baseline postive ADA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Positive Anti-Drug Antibody to PF-06755347
Day 15 positive ADA
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Positive Anti-Drug Antibody to PF-06755347
Day 71 positive ADA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Positive Anti-Drug Antibody to PF-06755347
Day 8 positive ADA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Positive Anti-Drug Antibody to PF-06755347
Day 36 positive ADA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts.Population: All enrolled participants treated who had at least 1 measurement of the exploratory endpoints of interest. Number of participants analyzed represents the total number of participants in each treatment group in the analysis population for this outcome measure. Number analyzed represents the number of participants who had reportable results for this outcome measure.
IFN-γ was one of the 3 cytokine biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
n=3 Participants
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
n=3 Participants
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
n=16 Participants
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints
Day 1: 8 hours post-dose
|
—
|
—
|
—
|
—
|
86.700 nanograms per liter (ng/L)
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
9.975 nanograms per liter (ng/L)
Standard Deviation 1.5910
|
1.373 nanograms per liter (ng/L)
Standard Deviation 1.9731
|
5.012 nanograms per liter (ng/L)
Standard Deviation 12.0362
|
14.400 nanograms per liter (ng/L)
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
—
|
—
|
-0.422 nanograms per liter (ng/L)
Standard Deviation 0.4181
|
|
Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints
Day 1: 12 hours post-dose
|
—
|
—
|
—
|
—
|
32.100 nanograms per liter (ng/L)
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
4.125 nanograms per liter (ng/L)
Standard Deviation 7.9550
|
2.477 nanograms per liter (ng/L)
Standard Deviation 2.8330
|
4.230 nanograms per liter (ng/L)
Standard Deviation 7.9003
|
11.207 nanograms per liter (ng/L)
Standard Deviation 5.8049
|
12.345 nanograms per liter (ng/L)
Standard Deviation 4.5839
|
8.327 nanograms per liter (ng/L)
Standard Deviation 6.7983
|
-0.155 nanograms per liter (ng/L)
Standard Deviation 0.8139
|
|
Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints
Day 2: 24 hours post-dose
|
0.430 nanograms per liter (ng/L)
Standard Deviation 2.1622
|
-1.750 nanograms per liter (ng/L)
Standard Deviation 4.2354
|
-0.403 nanograms per liter (ng/L)
Standard Deviation 0.8138
|
-0.317 nanograms per liter (ng/L)
Standard Deviation 0.3868
|
-12.533 nanograms per liter (ng/L)
Standard Deviation 21.7084
|
21.075 nanograms per liter (ng/L)
Standard Deviation 44.2295
|
2.340 nanograms per liter (ng/L)
Standard Deviation 3.1990
|
2.402 nanograms per liter (ng/L)
Standard Deviation 2.8296
|
3.322 nanograms per liter (ng/L)
Standard Deviation 2.1890
|
3.283 nanograms per liter (ng/L)
Standard Deviation 1.6786
|
-3.257 nanograms per liter (ng/L)
Standard Deviation 9.1184
|
1.027 nanograms per liter (ng/L)
Standard Deviation 3.3372
|
|
Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints
Day 3: 48 hours post-dose
|
5.400 nanograms per liter (ng/L)
Standard Deviation 11.9840
|
-4.707 nanograms per liter (ng/L)
Standard Deviation 8.0587
|
-0.083 nanograms per liter (ng/L)
Standard Deviation 0.1893
|
-0.497 nanograms per liter (ng/L)
Standard Deviation 0.4405
|
-8.733 nanograms per liter (ng/L)
Standard Deviation 15.1266
|
2.663 nanograms per liter (ng/L)
Standard Deviation 14.6931
|
2.820 nanograms per liter (ng/L)
Standard Deviation 5.9672
|
1.333 nanograms per liter (ng/L)
Standard Deviation 4.4335
|
2.937 nanograms per liter (ng/L)
Standard Deviation 3.8441
|
1.563 nanograms per liter (ng/L)
Standard Deviation 0.9806
|
-5.300 nanograms per liter (ng/L)
Standard Deviation 9.5979
|
12.843 nanograms per liter (ng/L)
Standard Deviation 50.7623
|
|
Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints
Day 4: 72 hours post-dose
|
2.877 nanograms per liter (ng/L)
Standard Deviation 8.4727
|
-4.893 nanograms per liter (ng/L)
Standard Deviation 8.0609
|
-0.433 nanograms per liter (ng/L)
Standard Deviation 1.0587
|
-0.363 nanograms per liter (ng/L)
Standard Deviation 0.3702
|
-15.327 nanograms per liter (ng/L)
Standard Deviation 26.5466
|
-3.660 nanograms per liter (ng/L)
Standard Deviation 5.9789
|
1.197 nanograms per liter (ng/L)
Standard Deviation 2.2445
|
-2.492 nanograms per liter (ng/L)
Standard Deviation 8.4374
|
0.968 nanograms per liter (ng/L)
Standard Deviation 2.5824
|
0.552 nanograms per liter (ng/L)
Standard Deviation 1.0780
|
-6.063 nanograms per liter (ng/L)
Standard Deviation 10.1365
|
27.946 nanograms per liter (ng/L)
Standard Deviation 111.802
|
|
Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints
Day 8: 168 hours post-dose
|
-0.817 nanograms per liter (ng/L)
Standard Deviation 2.8587
|
-8.260 nanograms per liter (ng/L)
Standard Deviation 13.1193
|
-0.487 nanograms per liter (ng/L)
Standard Deviation 0.7658
|
-0.230 nanograms per liter (ng/L)
Standard Deviation 0.3279
|
-16.247 nanograms per liter (ng/L)
Standard Deviation 28.1401
|
-3.290 nanograms per liter (ng/L)
Standard Deviation 3.3698
|
-0.160 nanograms per liter (ng/L)
Standard Deviation 1.5159
|
-3.900 nanograms per liter (ng/L)
Standard Deviation 12.0196
|
-2.040 nanograms per liter (ng/L)
Standard Deviation 3.6754
|
-0.344 nanograms per liter (ng/L)
Standard Deviation 0.9542
|
-5.457 nanograms per liter (ng/L)
Standard Deviation 9.9449
|
1.006 nanograms per liter (ng/L)
Standard Deviation 3.8100
|
|
Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints
Day 1: 1 hour post-dose
|
-0.303 nanograms per liter (ng/L)
Standard Deviation 0.0950
|
-3.230 nanograms per liter (ng/L)
Standard Deviation 5.0126
|
-0.337 nanograms per liter (ng/L)
Standard Deviation 0.5686
|
3.903 nanograms per liter (ng/L)
Standard Deviation 3.7969
|
20.240 nanograms per liter (ng/L)
Standard Deviation 14.2259
|
26.157 nanograms per liter (ng/L)
Standard Deviation 17.0904
|
-0.423 nanograms per liter (ng/L)
Standard Deviation 0.2454
|
-0.145 nanograms per liter (ng/L)
Standard Deviation 0.8771
|
-0.030 nanograms per liter (ng/L)
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
—
|
—
|
-0.554 nanograms per liter (ng/L)
Standard Deviation 0.4981
|
|
Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints
Day 1: 3 hours post-dose
|
-0.440 nanograms per liter (ng/L)
Standard Deviation 0.7134
|
-0.293 nanograms per liter (ng/L)
Standard Deviation 3.4514
|
24.490 nanograms per liter (ng/L)
Standard Deviation 22.6078
|
50.667 nanograms per liter (ng/L)
Standard Deviation 29.7923
|
292.287 nanograms per liter (ng/L)
Standard Deviation 233.1423
|
250.257 nanograms per liter (ng/L)
Standard Deviation 301.3490
|
-0.403 nanograms per liter (ng/L)
Standard Deviation 0.4239
|
0.295 nanograms per liter (ng/L)
Standard Deviation 0.8520
|
0.330 nanograms per liter (ng/L)
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
—
|
—
|
-0.448 nanograms per liter (ng/L)
Standard Deviation 0.4631
|
|
Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints
Day 1: 5 hours post-dose
|
0.383 nanograms per liter (ng/L)
Standard Deviation 1.2687
|
-1.227 nanograms per liter (ng/L)
Standard Deviation 5.1897
|
16.790 nanograms per liter (ng/L)
Standard Deviation 13.5079
|
21.467 nanograms per liter (ng/L)
Standard Deviation 11.4311
|
160.287 nanograms per liter (ng/L)
Standard Deviation 157.2547
|
41.575 nanograms per liter (ng/L)
Standard Deviation 15.6624
|
0.223 nanograms per liter (ng/L)
Standard Deviation 1.2471
|
4.155 nanograms per liter (ng/L)
Standard Deviation 10.1704
|
4.403 nanograms per liter (ng/L)
Standard Deviation 5.7437
|
53.540 nanograms per liter (ng/L)
Standard Deviation 65.4359
|
14.793 nanograms per liter (ng/L)
Standard Deviation 7.5312
|
-0.337 nanograms per liter (ng/L)
Standard Deviation 0.7686
|
|
Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints
Day 5: 96 hours post-dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.558 nanograms per liter (ng/L)
Standard Deviation 2.0766
|
8.516 nanograms per liter (ng/L)
Standard Deviation 15.1062
|
-6.123 nanograms per liter (ng/L)
Standard Deviation 10.0962
|
1.118 nanograms per liter (ng/L)
Standard Deviation 1.5380
|
|
Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints
Day 15: 336 hours post-dose
|
-0.413 nanograms per liter (ng/L)
Standard Deviation 3.6272
|
-10.640 nanograms per liter (ng/L)
Standard Deviation 16.1897
|
1.240 nanograms per liter (ng/L)
Standard Deviation 1.0792
|
-0.050 nanograms per liter (ng/L)
Standard Deviation 0.5766
|
0.000 nanograms per liter (ng/L)
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
0.900 nanograms per liter (ng/L)
Standard Deviation 9.2772
|
0.005 nanograms per liter (ng/L)
Standard Deviation 0.2475
|
-5.550 nanograms per liter (ng/L)
Standard Deviation 12.2071
|
-1.864 nanograms per liter (ng/L)
Standard Deviation 3.5365
|
-0.133 nanograms per liter (ng/L)
Standard Deviation 0.9903
|
-2.833 nanograms per liter (ng/L)
Standard Deviation 4.3584
|
0.713 nanograms per liter (ng/L)
Standard Deviation 5.8229
|
|
Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints
Day 36: 840 hours post-dose
|
25.507 nanograms per liter (ng/L)
Standard Deviation 44.6205
|
-11.603 nanograms per liter (ng/L)
Standard Deviation 18.4042
|
0.510 nanograms per liter (ng/L)
Standard Deviation 0.7119
|
0.097 nanograms per liter (ng/L)
Standard Deviation 0.3807
|
—
|
-0.960 nanograms per liter (ng/L)
Standard Deviation 7.2832
|
2.985 nanograms per liter (ng/L)
Standard Deviation 2.8214
|
-5.598 nanograms per liter (ng/L)
Standard Deviation 11.5371
|
5.650 nanograms per liter (ng/L)
Standard Deviation 12.4743
|
-0.188 nanograms per liter (ng/L)
Standard Deviation 1.5621
|
-4.397 nanograms per liter (ng/L)
Standard Deviation 7.4304
|
1.276 nanograms per liter (ng/L)
Standard Deviation 3.1066
|
|
Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints
Day 71: 1680 hours post-dose
|
—
|
—
|
—
|
—
|
—
|
—
|
0.853 nanograms per liter (ng/L)
Standard Deviation 0.2040
|
-5.755 nanograms per liter (ng/L)
Standard Deviation 12.4057
|
-2.120 nanograms per liter (ng/L)
Standard Deviation 4.0010
|
0.082 nanograms per liter (ng/L)
Standard Deviation 1.6527
|
-4.830 nanograms per liter (ng/L)
Standard Deviation 10.8140
|
1.019 nanograms per liter (ng/L)
Standard Deviation 0.8362
|
SECONDARY outcome
Timeframe: Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts.Population: All enrolled subjects treated who had at least 1 measurement of the exploratory endpoints of interest. "Number Analyzed" in each row will be 0 if no participant had at least 1 measurement of the exploratory endpoints of interest within the specified timeframe.
TNFα was one of the 3 cytokine biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
n=3 Participants
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
n=3 Participants
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
n=16 Participants
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints
Day 2: 24 hours post-dose
|
0.2567 ng/L
Standard Deviation 0.06110
|
0.0567 ng/L
Standard Deviation 0.31501
|
1.3067 ng/L
Standard Deviation 0.25325
|
0.8700 ng/L
Standard Deviation 0.09644
|
2.8000 ng/L
Standard Deviation 1.25790
|
1.6150 ng/L
Standard Deviation 1.77484
|
0.1383 ng/L
Standard Deviation 0.05777
|
0.3792 ng/L
Standard Deviation 0.53143
|
0.9425 ng/L
Standard Deviation 0.50586
|
1.0875 ng/L
Standard Deviation 0.40787
|
0.7370 ng/L
Standard Deviation 0.19120
|
0.0585 ng/L
Standard Deviation 0.13732
|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints
Day 15: 336 hours post-dose
|
-0.1833 ng/L
Standard Deviation 0.37873
|
-0.4133 ng/L
Standard Deviation 0.56722
|
0.5033 ng/L
Standard Deviation 0.71501
|
-0.1233 ng/L
Standard Deviation 0.10017
|
0.2300 ng/L
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
-0.5810 ng/L
Standard Deviation 0.96308
|
0.1685 ng/L
Standard Deviation 0.26092
|
0.2715 ng/L
Standard Deviation 0.36900
|
0.0280 ng/L
Standard Deviation 0.16664
|
0.0310 ng/L
Standard Deviation 0.12138
|
0.1297 ng/L
Standard Deviation 0.30426
|
0.0909 ng/L
Standard Deviation 0.49582
|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints
Day 36: 840 hours post-dose
|
0.3233 ng/L
Standard Deviation 0.21733
|
-0.5767 ng/L
Standard Deviation 0.99470
|
0.4867 ng/L
Standard Deviation 0.96500
|
0.2633 ng/L
Standard Deviation 0.63129
|
—
|
-1.2265 ng/L
Standard Deviation 0.15910
|
0.0650 ng/L
Standard Deviation 0.41154
|
0.4748 ng/L
Standard Deviation 0.44527
|
0.2776 ng/L
Standard Deviation 0.56067
|
-0.1340 ng/L
Standard Deviation 0.19649
|
-0.0040 ng/L
Standard Deviation 0.02330
|
-0.0090 ng/L
Standard Deviation 0.85788
|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints
Day 1: 1 hour post-dose
|
-0.0500 ng/L
Standard Deviation 0.06000
|
-0.0667 ng/L
Standard Deviation 0.31565
|
0.6533 ng/L
Standard Deviation 0.83032
|
4.8733 ng/L
Standard Deviation 3.27147
|
59.7100 ng/L
Standard Deviation 34.37035
|
38.5200 ng/L
Standard Deviation 29.69790
|
-0.0250 ng/L
Standard Deviation 0.06051
|
0.0048 ng/L
Standard Deviation 0.06199
|
0.1200 ng/L
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
—
|
—
|
0.0055 ng/L
Standard Deviation 0.11117
|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints
Day 1: 3 hours post-dose
|
-0.1100 ng/L
Standard Deviation 0.21932
|
0.4567 ng/L
Standard Deviation 0.21939
|
10.7767 ng/L
Standard Deviation 10.67258
|
20.4567 ng/L
Standard Deviation 7.74517
|
217.9767 ng/L
Standard Deviation 78.32721
|
97.4267 ng/L
Standard Deviation 89.31240
|
0.0327 ng/L
Standard Deviation 0.08016
|
0.1905 ng/L
Standard Deviation 0.27975
|
0.3600 ng/L
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
—
|
—
|
0.0198 ng/L
Standard Deviation 0.12203
|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints
Day 1: 5 hours post-dose
|
-0.0833 ng/L
Standard Deviation 0.08505
|
0.1333 ng/L
Standard Deviation 0.27062
|
5.8100 ng/L
Standard Deviation 3.05779
|
9.0900 ng/L
Standard Deviation 1.62613
|
49.6433 ng/L
Standard Deviation 18.57913
|
15.6900 ng/L
Standard Deviation 4.25678
|
0.0673 ng/L
Standard Deviation 0.10808
|
0.5760 ng/L
Standard Deviation 1.36848
|
0.3422 ng/L
Standard Deviation 0.43494
|
10.4592 ng/L
Standard Deviation 16.00977
|
1.7770 ng/L
Standard Deviation 0.92867
|
-0.1024 ng/L
Standard Deviation 0.08281
|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints
Day 1: 8 hours post-dose
|
—
|
—
|
—
|
—
|
23.8900 ng/L
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
5.6750 ng/L
Standard Deviation 2.41123
|
0.3103 ng/L
Standard Deviation 0.37419
|
0.6442 ng/L
Standard Deviation 1.36307
|
1.7800 ng/L
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
—
|
—
|
-0.1326 ng/L
Standard Deviation 0.13676
|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints
Day 1: 12 hours post-dose
|
—
|
—
|
—
|
—
|
11.0900 ng/L
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
2.7700 ng/L
Standard Deviation 1.41421
|
0.4367 ng/L
Standard Deviation 0.48959
|
0.4453 ng/L
Standard Deviation 0.65376
|
1.1792 ng/L
Standard Deviation 0.71557
|
1.7025 ng/L
Standard Deviation 0.71450
|
1.3270 ng/L
Standard Deviation 0.18793
|
-0.1489 ng/L
Standard Deviation 0.13550
|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints
Day 3: 48 hours post-dose
|
0.2200 ng/L
Standard Deviation 0.30447
|
0.0333 ng/L
Standard Deviation 0.21362
|
0.5967 ng/L
Standard Deviation 0.17559
|
0.0933 ng/L
Standard Deviation 0.54151
|
0.4967 ng/L
Standard Deviation 0.30022
|
0.7533 ng/L
Standard Deviation 1.52998
|
0.0883 ng/L
Standard Deviation 0.06213
|
0.1830 ng/L
Standard Deviation 0.20827
|
0.5225 ng/L
Standard Deviation 0.24791
|
0.5575 ng/L
Standard Deviation 0.24078
|
0.4237 ng/L
Standard Deviation 0.06199
|
0.0784 ng/L
Standard Deviation 0.29068
|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints
Day 4: 72 hours post-dose
|
0.0433 ng/L
Standard Deviation 0.44004
|
-0.0167 ng/L
Standard Deviation 0.39954
|
0.2767 ng/L
Standard Deviation 0.32929
|
-0.1467 ng/L
Standard Deviation 0.32470
|
0.0900 ng/L
Standard Deviation 0.22539
|
0.7100 ng/L
Standard Deviation 1.04159
|
0.0227 ng/L
Standard Deviation 0.12889
|
0.1182 ng/L
Standard Deviation 0.20360
|
0.2665 ng/L
Standard Deviation 0.14113
|
0.1608 ng/L
Standard Deviation 0.17623
|
0.3293 ng/L
Standard Deviation 0.11039
|
0.2039 ng/L
Standard Deviation 0.73037
|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints
Day 5: 96 hours post-dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.1820 ng/L
Standard Deviation 0.10060
|
0.1644 ng/L
Standard Deviation 0.14800
|
0.2643 ng/L
Standard Deviation 0.06914
|
-0.0080 ng/L
Standard Deviation 0.10568
|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints
Day 8: 168 hours post-dose
|
-0.1600 ng/L
Standard Deviation 0.38974
|
-0.3633 ng/L
Standard Deviation 0.52205
|
0.1867 ng/L
Standard Deviation 0.54647
|
-0.0667 ng/L
Standard Deviation 0.43730
|
0.0267 ng/L
Standard Deviation 0.31342
|
0.2233 ng/L
Standard Deviation 0.32130
|
-0.0350 ng/L
Standard Deviation 0.12758
|
0.0383 ng/L
Standard Deviation 0.17292
|
-0.0317 ng/L
Standard Deviation 0.17725
|
0.0098 ng/L
Standard Deviation 0.04696
|
0.1697 ng/L
Standard Deviation 0.05604
|
0.0237 ng/L
Standard Deviation 0.20192
|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints
Day 71: 840 hours post-dose
|
—
|
—
|
—
|
—
|
—
|
—
|
0.1363 ng/L
Standard Deviation 0.25455
|
0.5913 ng/L
Standard Deviation 0.28774
|
-0.0340 ng/L
Standard Deviation 0.25211
|
-0.1698 ng/L
Standard Deviation 0.20600
|
0.1327 ng/L
Standard Deviation 0.19433
|
-0.0820 ng/L
Standard Deviation 0.24109
|
SECONDARY outcome
Timeframe: Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts.Population: All enrolled subjects treated who had at least 1 measurement of the exploratory endpoints of interest. "Number Analyzed" in each row will be 0 if no participant had at least 1 measurement of the exploratory endpoints of interest within the specified timeframe.
IL-6 was one of the 3 cytokine biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
n=3 Participants
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
n=3 Participants
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
n=16 Participants
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints
Day 1: 5 hours post-dose
|
0.8893 ng/L
Standard Deviation 0.97631
|
0.6083 ng/L
Standard Deviation 0.46302
|
5.4180 ng/L
Standard Deviation 6.21463
|
10.7307 ng/L
Standard Deviation 5.75904
|
817.4487 ng/L
Standard Deviation 952.5663
|
16.1545 ng/L
Standard Deviation 9.43210
|
0.2970 ng/L
Standard Deviation 0.31973
|
2.8793 ng/L
Standard Deviation 2.33024
|
1.7130 ng/L
Standard Deviation 2.18458
|
53.7213 ng/L
Standard Deviation 107.2734
|
11.1390 ng/L
Standard Deviation 16.70153
|
0.2653 ng/L
Standard Deviation 0.48087
|
|
Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints
Day 4: 72 hours post-dose
|
0.3947 ng/L
Standard Deviation 0.68358
|
0.3010 ng/L
Standard Deviation 0.30959
|
-0.0087 ng/L
Standard Deviation 0.01250
|
0.0960 ng/L
Standard Deviation 0.16628
|
0.6127 ng/L
Standard Deviation 1.06117
|
-0.1297 ng/L
Standard Deviation 0.26905
|
0.1830 ng/L
Standard Deviation 0.16928
|
0.1143 ng/L
Standard Deviation 0.22064
|
0.2382 ng/L
Standard Deviation 0.53605
|
0.1062 ng/L
Standard Deviation 0.13652
|
-0.0157 ng/L
Standard Deviation 0.02714
|
0.1368 ng/L
Standard Deviation 0.81459
|
|
Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints
Day 5: 96 hours post-dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0834 ng/L
Standard Deviation 0.73122
|
1.7690 ng/L
Standard Deviation 3.78958
|
-0.0277 ng/L
Standard Deviation 0.04792
|
0.0000 ng/L
Standard Deviation 0.0000
|
|
Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints
Day 1: 1 hour post-dose
|
0.0177 ng/L
Standard Deviation 0.03060
|
-0.0207 ng/L
Standard Deviation 0.08003
|
0.0743 ng/L
Standard Deviation 0.12009
|
0.9653 ng/L
Standard Deviation 1.35472
|
0.6757 ng/L
Standard Deviation 0.80530
|
2.1110 ng/L
Standard Deviation 2.86966
|
0.0000 ng/L
Standard Deviation 0.00000
|
0.2665 ng/L
Standard Deviation 0.38316
|
0.1410 ng/L
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
—
|
—
|
0.0120 ng/L
Standard Deviation 0.07478
|
|
Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints
Day 1: 3 hours post-dose
|
0.7137 ng/L
Standard Deviation 0.53129
|
0.3280 ng/L
Standard Deviation 0.33207
|
4.7613 ng/L
Standard Deviation 5.00708
|
24.9907 ng/L
Standard Deviation 28.82106
|
1261.782 ng/L
Standard Deviation 1377.243
|
365.8777 ng/L
Standard Deviation 534.9345
|
0.2863 ng/L
Standard Deviation 0.13785
|
2.3943 ng/L
Standard Deviation 2.26382
|
1.1740 ng/L
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
—
|
—
|
0.3684 ng/L
Standard Deviation 0.77453
|
|
Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints
Day 1: 8 hours post-dose
|
—
|
—
|
—
|
—
|
35.2980 ng/L
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
0.3100 ng/L
Standard Deviation 0.65620
|
0.4090 ng/L
Standard Deviation 0.31213
|
3.1483 ng/L
Standard Deviation 4.27777
|
1.7440 ng/L
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
—
|
—
|
0.6368 ng/L
Standard Deviation 0.62657
|
|
Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints
Day 1: 12 hours post-dose
|
—
|
—
|
—
|
—
|
6.4480 ng/L
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
0.1375 ng/L
Standard Deviation 0.81529
|
0.7460 ng/L
Standard Deviation 0.42248
|
3.3927 ng/L
Standard Deviation 1.80711
|
1.9242 ng/L
Standard Deviation 2.23190
|
1.2097 ng/L
Standard Deviation 0.72824
|
0.6550 ng/L
Standard Deviation 0.33707
|
0.3799 ng/L
Standard Deviation 0.63486
|
|
Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints
Day 2: 24 hours post-dose
|
0.0817 ng/L
Standard Deviation 0.14145
|
0.1917 ng/L
Standard Deviation 0.24744
|
0.2260 ng/L
Standard Deviation 0.23010
|
0.1040 ng/L
Standard Deviation 0.09938
|
0.8647 ng/L
Standard Deviation 0.93571
|
-0.0495 ng/L
Standard Deviation 0.55084
|
0.4147 ng/L
Standard Deviation 0.71822
|
3.5448 ng/L
Standard Deviation 3.52636
|
0.2730 ng/L
Standard Deviation 0.29167
|
0.0957 ng/L
Standard Deviation 0.13221
|
1.3477 ng/L
Standard Deviation 2.13897
|
0.1433 ng/L
Standard Deviation 0.20404
|
|
Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints
Day 3: 48 hours post-dose
|
0.3813 ng/L
Standard Deviation 0.66049
|
-0.0063 ng/L
Standard Deviation 0.04087
|
0.0927 ng/L
Standard Deviation 0.10203
|
0.0120 ng/L
Standard Deviation 0.4405
|
-0.0667 ng/L
Standard Deviation 0.11547
|
-0.0937 ng/L
Standard Deviation 0.30933
|
0.5713 ng/L
Standard Deviation 0.98958
|
0.2855 ng/L
Standard Deviation 0.60079
|
2.1285 ng/L
Standard Deviation 4.43835
|
0.0155 ng/L
Standard Deviation 0.03797
|
0.5043 ng/L
Standard Deviation 0.80624
|
0.0974 ng/L
Standard Deviation 0.35056
|
|
Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints
Day 8: 168 hours post-dose
|
0.0787 ng/L
Standard Deviation 0.13625
|
-0.0310 ng/L
Standard Deviation 0.05369
|
0.0727 ng/L
Standard Deviation 0.06972
|
0.0000 ng/L
Standard Deviation 0.0000
|
0.0070 ng/L
Standard Deviation 0.23658
|
-0.1203 ng/L
Standard Deviation 0.27872
|
0.0000 ng/L
Standard Deviation 0.00000
|
0.0780 ng/L
Standard Deviation 0.10187
|
0.0100 ng/L
Standard Deviation 0.81680
|
0.0284 ng/L
Standard Deviation 0.06350
|
0.0180 ng/L
Standard Deviation 0.03118
|
-0.0282 ng/L
Standard Deviation 0.56396
|
|
Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints
Day 15: 336 hours post-dose
|
0.0847 ng/L
Standard Deviation 0.11301
|
0.1570 ng/L
Standard Deviation 0.27193
|
0.1563 ng/L
Standard Deviation 0.15264
|
2.1150 ng/L
Standard Deviation 3.50770
|
0.0000 ng/L
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
0.5620 ng/L
Standard Deviation 0.79479
|
0.0000 ng/L
Standard Deviation 0.0000
|
0.0298 ng/L
Standard Deviation 0.08751
|
-0.0998 ng/L
Standard Deviation 0.40069
|
0.0000 ng/L
Standard Deviation 0.0000
|
0.2797 ng/L
Standard Deviation 0.48440
|
-0.0737 ng/L
Standard Deviation 0.43828
|
|
Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints
Day 36: 840 hours post-dose
|
0.7927 ng/L
Standard Deviation 1.36082
|
-0.0247 ng/L
Standard Deviation 0.04272
|
0.3590 ng/L
Standard Deviation 0.27029
|
0.0340 ng/L
Standard Deviation 0.05889
|
—
|
0.0000 ng/L
Standard Deviation 0.0000
|
0.0105 ng/L
Standard Deviation 0.01485
|
-0.0047 ng/L
Standard Deviation 0.01143
|
0.1396 ng/L
Standard Deviation 0.23005
|
0.0774 ng/L
Standard Deviation 0.17307
|
0.0710 ng/L
Standard Deviation 0.12298
|
0.0861 ng/L
Standard Deviation 0.15271
|
|
Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints
Day 71: 1680 hours post-dose
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0000 ng/L
Standard Deviation 0.0000
|
0.0255 ng/L
Standard Deviation 0.07700
|
-0.0758 ng/L
Standard Deviation 0.61407
|
0.0000 ng/L
Standard Deviation 0.0000
|
0.2030 ng/L
Standard Deviation 0.35161
|
0.0539 ng/L
Standard Deviation 0.16145
|
SECONDARY outcome
Timeframe: Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts.Population: All enrolled subjects treated who had at least 1 measurement of the exploratory endpoints of interest. "Number Analyzed" in each row will be 0 if no participant had at least 1 measurement of the exploratory endpoints of interest within the specified timeframe.
C3a was one of the 3 complement components/biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
n=3 Participants
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
n=3 Participants
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
n=16 Participants
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints
Day 1: 3 hours post-dose
|
0.0 micrograms per liter (mcg/L)
Standard Deviation 0.00
|
0.0 micrograms per liter (mcg/L)
Standard Deviation 0.00
|
-133.3 micrograms per liter (mcg/L)
Standard Deviation 675.45
|
-827.0 micrograms per liter (mcg/L)
Standard Deviation 1293.35
|
1017.0 micrograms per liter (mcg/L)
Standard Deviation 1761.50
|
360.0 micrograms per liter (mcg/L)
Standard Deviation 2941.56
|
-13.3 micrograms per liter (mcg/L)
Standard Deviation 23.09
|
1138.7 micrograms per liter (mcg/L)
Standard Deviation 2152.68
|
0.0 micrograms per liter (mcg/L)
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
—
|
—
|
-364.0 micrograms per liter (mcg/L)
Standard Deviation 937.82
|
|
Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints
Day 2: 24 hours post-dose
|
0.0 micrograms per liter (mcg/L)
Standard Deviation 0.00
|
33.7 micrograms per liter (mcg/L)
Standard Deviation 58.31
|
3626.3 micrograms per liter (mcg/L)
Standard Deviation 4819.80
|
-1394.0 micrograms per liter (mcg/L)
Standard Deviation 1422.73
|
507.0 micrograms per liter (mcg/L)
Standard Deviation 878.15
|
-1425.5 micrograms per liter (mcg/L)
Standard Deviation 1888.68
|
526.7 micrograms per liter (mcg/L)
Standard Deviation 1388.08
|
588.5 micrograms per liter (mcg/L)
Standard Deviation 1225.78
|
383.3 micrograms per liter (mcg/L)
Standard Deviation 890.52
|
-548.5 micrograms per liter (mcg/L)
Standard Deviation 1846.32
|
-76.7 micrograms per liter (mcg/L)
Standard Deviation 132.79
|
-187.4 micrograms per liter (mcg/L)
Standard Deviation 1055.28
|
|
Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints
Day 3: 48 hours post-dose
|
0.0 micrograms per liter (mcg/L)
Standard Deviation 0.00
|
10.3 micrograms per liter (mcg/L)
Standard Deviation 17.90
|
516.7 micrograms per liter (mcg/L)
Standard Deviation 1030.55
|
-937.3 micrograms per liter (mcg/L)
Standard Deviation 2577.06
|
737.0 micrograms per liter (mcg/L)
Standard Deviation 1276.52
|
-333.7 micrograms per liter (mcg/L)
Standard Deviation 1803.48
|
-173.7 micrograms per liter (mcg/L)
Standard Deviation 300.80
|
210.2 micrograms per liter (mcg/L)
Standard Deviation 711.62
|
1418.5 micrograms per liter (mcg/L)
Standard Deviation 2194.12
|
-640.5 micrograms per liter (mcg/L)
Standard Deviation 1839.01
|
330.0 micrograms per liter (mcg/L)
Standard Deviation 571.58
|
174.3 micrograms per liter (mcg/L)
Standard Deviation 1669.50
|
|
Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints
Day 15: 336 hours post-dose
|
0.0 micrograms per liter (mcg/L)
Standard Deviation 0.00
|
0.0 micrograms per liter (mcg/L)
Standard Deviation 0.00
|
519.7 micrograms per liter (mcg/L)
Standard Deviation 2234.46
|
-780.3 micrograms per liter (mcg/L)
Standard Deviation 594.56
|
0.0 micrograms per liter (mcg/L)
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
129.5 micrograms per liter (mcg/L)
Standard Deviation 1075.51
|
-260.5 micrograms per liter (mcg/L)
Standard Deviation 368.40
|
1410.5 micrograms per liter (mcg/L)
Standard Deviation 2078.58
|
-536.4 micrograms per liter (mcg/L)
Standard Deviation 602.28
|
-688.0 micrograms per liter (mcg/L)
Standard Deviation 2313.92
|
693.3 micrograms per liter (mcg/L)
Standard Deviation 1200.89
|
-70.7 micrograms per liter (mcg/L)
Standard Deviation 1343.24
|
|
Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints
Day 36: 840 hours post-dose
|
1727.3 micrograms per liter (mcg/L)
Standard Deviation 1545.92
|
0.0 micrograms per liter (mcg/L)
Standard Deviation 0.00
|
1960.0 micrograms per liter (mcg/L)
Standard Deviation 2817.68
|
-1561.0 micrograms per liter (mcg/L)
Standard Deviation 1700.71
|
—
|
-656.0 micrograms per liter (mcg/L)
Standard Deviation 35.36
|
-260.5 micrograms per liter (mcg/L)
Standard Deviation 368.40
|
567.2 micrograms per liter (mcg/L)
Standard Deviation 729.62
|
1062.2 micrograms per liter (mcg/L)
Standard Deviation 2324.85
|
-1298.4 micrograms per liter (mcg/L)
Standard Deviation 1672.16
|
693.3 micrograms per liter (mcg/L)
Standard Deviation 1200.89
|
470.0 micrograms per liter (mcg/L)
Standard Deviation 3018.14
|
|
Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints
Day 1: 1 hour post-dose
|
2234.0 micrograms per liter (mcg/L)
Standard Deviation 2663.07
|
0.0 micrograms per liter (mcg/L)
Standard Deviation 0.00
|
1570.0 micrograms per liter (mcg/L)
Standard Deviation 795.05
|
730.0 micrograms per liter (mcg/L)
Standard Deviation 1889.87
|
2680.7 micrograms per liter (mcg/L)
Standard Deviation 2327.03
|
4310.0 micrograms per liter (mcg/L)
Standard Deviation 3997.14
|
260.0 micrograms per liter (mcg/L)
Standard Deviation 450.33
|
131.8 micrograms per liter (mcg/L)
Standard Deviation 317.57
|
0.0 micrograms per liter (mcg/L)
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
—
|
—
|
-425.1 micrograms per liter (mcg/L)
Standard Deviation 779.62
|
|
Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints
Day 1: 5 hours post-dose
|
0.0 micrograms per liter (mcg/L)
Standard Deviation 0.00
|
0.0 micrograms per liter (mcg/L)
Standard Deviation 0.00
|
1219.7 micrograms per liter (mcg/L)
Standard Deviation 2513.81
|
-1214.0 micrograms per liter (mcg/L)
Standard Deviation 1129.48
|
33.7 micrograms per liter (mcg/L)
Standard Deviation 58.31
|
-115.5 micrograms per liter (mcg/L)
Standard Deviation 3741.30
|
13.3 micrograms per liter (mcg/L)
Standard Deviation 23.09
|
188.5 micrograms per liter (mcg/L)
Standard Deviation 296.99
|
1348.5 micrograms per liter (mcg/L)
Standard Deviation 1359.62
|
-170.2 micrograms per liter (mcg/L)
Standard Deviation 796.82
|
1093.7 micrograms per liter (mcg/L)
Standard Deviation 1681.60
|
-162.0 micrograms per liter (mcg/L)
Standard Deviation 767.87
|
|
Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints
Day 1: 8 hours post-dose
|
—
|
—
|
—
|
—
|
0.0 micrograms per liter (mcg/L)
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
-430.5 micrograms per liter (mcg/L)
Standard Deviation 3295.82
|
-70.0 micrograms per liter (mcg/L)
Standard Deviation 121.24
|
541.8 micrograms per liter (mcg/L)
Standard Deviation 844.36
|
0.0 micrograms per liter (mcg/L)
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
—
|
—
|
-176.0 micrograms per liter (mcg/L)
Standard Deviation 393.55
|
|
Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints
Day 1: 12 hours post-dose
|
—
|
—
|
—
|
—
|
0.0 micrograms per liter (mcg/L)
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
1650.0 micrograms per liter (mcg/L)
Standard Deviation 3691.10
|
-173.7 micrograms per liter (mcg/L)
Standard Deviation 300.80
|
705.2 micrograms per liter (mcg/L)
Standard Deviation 1132.91
|
518.3 micrograms per liter (mcg/L)
Standard Deviation 752.66
|
-583.5 micrograms per liter (mcg/L)
Standard Deviation 1326.10
|
440.0 micrograms per liter (mcg/L)
Standard Deviation 762.10
|
569.3 micrograms per liter (mcg/L)
Standard Deviation 1040.58
|
|
Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints
Day 4: 72 hours post-dose
|
83.7 micrograms per liter (mcg/L)
Standard Deviation 144.9
|
80.3 micrograms per liter (mcg/L)
Standard Deviation 139.14
|
-170.0 micrograms per liter (mcg/L)
Standard Deviation 810.19
|
-1561.0 micrograms per liter (mcg/L)
Standard Deviation 1700.71
|
0.0 micrograms per liter (mcg/L)
Standard Deviation 0.00
|
-757.0 micrograms per liter (mcg/L)
Standard Deviation 1336.62
|
-53.3 micrograms per liter (mcg/L)
Standard Deviation 92.38
|
65.0 micrograms per liter (mcg/L)
Standard Deviation 581.79
|
295.2 micrograms per liter (mcg/L)
Standard Deviation 739.73
|
-1133.7 micrograms per liter (mcg/L)
Standard Deviation 1614.09
|
710.0 micrograms per liter (mcg/L)
Standard Deviation 1229.76
|
-77.6 micrograms per liter (mcg/L)
Standard Deviation 766.58
|
|
Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints
Day 5: 96 hours post-dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
475.8 micrograms per liter (mcg/L)
Standard Deviation 777.97
|
-252.2 micrograms per liter (mcg/L)
Standard Deviation 2190.36
|
-346.7 micrograms per liter (mcg/L)
Standard Deviation 600.44
|
788.2 micrograms per liter (mcg/L)
Standard Deviation 2632.47
|
|
Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints
Day 8: 168 hours post-dose
|
407.0 micrograms per liter (mcg/L)
Standard Deviation 704.94
|
0.0 micrograms per liter (mcg/L)
Standard Deviation 0.00
|
-240.7 micrograms per liter (mcg/L)
Standard Deviation 1064.66
|
-1120.7 micrograms per liter (mcg/L)
Standard Deviation 2039.85
|
403.7 micrograms per liter (mcg/L)
Standard Deviation 699.17
|
-407.0 micrograms per liter (mcg/L)
Standard Deviation 2048.41
|
-173.7 micrograms per liter (mcg/L)
Standard Deviation 300.80
|
530.2 micrograms per liter (mcg/L)
Standard Deviation 822.22
|
876.7 micrograms per liter (mcg/L)
Standard Deviation 993.91
|
-1078.2 micrograms per liter (mcg/L)
Standard Deviation 1941.86
|
383.3 micrograms per liter (mcg/L)
Standard Deviation 663.95
|
262.4 micrograms per liter (mcg/L)
Standard Deviation 1096.43
|
|
Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints
Day 71: 1680 hours post-dose
|
—
|
—
|
—
|
—
|
—
|
—
|
1713.3 micrograms per liter (mcg/L)
Standard Deviation 3428.69
|
1830.8 micrograms per liter (mcg/L)
Standard Deviation 1654.01
|
2330.3 micrograms per liter (mcg/L)
Standard Deviation 3100.19
|
-1734.6 micrograms per liter (mcg/L)
Standard Deviation 1602.72
|
156.7 micrograms per liter (mcg/L)
Standard Deviation 271.35
|
436.1 micrograms per liter (mcg/L)
Standard Deviation 1343.41
|
SECONDARY outcome
Timeframe: Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts.Population: All enrolled subjects treated who had at least 1 measurement of the exploratory endpoints of interest. "Number Analyzed" in each row will be 0 if no participant had at least 1 measurement of the exploratory endpoints of interest within the specified timeframe.
C5a was one of the 3 complement components/biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
n=3 Participants
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
n=3 Participants
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
n=16 Participants
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints
Day 36: 840 hours post-dose
|
2.077 mcg/L
Standard Deviation 1.8309
|
-1.083 mcg/L
Standard Deviation 1.1453
|
-0.113 mcg/L
Standard Deviation 0.2747
|
-0.657 mcg/L
Standard Deviation 1.7796
|
—
|
-0.660 mcg/L
Standard Deviation 0.0283
|
-0.085 mcg/L
Standard Deviation 0.1202
|
2.277 mcg/L
Standard Deviation 6.9301
|
-10.962 mcg/L
Standard Deviation 14.6454
|
-0.456 mcg/L
Standard Deviation 0.8780
|
-0.283 mcg/L
Standard Deviation 0.5346
|
0.464 mcg/L
Standard Deviation 1.5409
|
|
Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints
Day 71: 1680 hours post-dose
|
—
|
—
|
—
|
—
|
—
|
—
|
0.580 mcg/L
Standard Deviation 1.1549
|
10.358 mcg/L
Standard Deviation 18.0554
|
-9.218 mcg/L
Standard Deviation 13.7046
|
0.080 mcg/L
Standard Deviation 1.3326
|
-0.310 mcg/L
Standard Deviation 0.5112
|
1.984 mcg/L
Standard Deviation 4.3754
|
|
Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints
Day 1: 1 hour post-dose
|
0.623 mcg/L
Standard Deviation 0.4709
|
-0.167 mcg/L
Standard Deviation 1.6862
|
0.213 mcg/L
Standard Deviation 0.2676
|
-0.283 mcg/L
Standard Deviation 0.6417
|
-0.627 mcg/L
Standard Deviation 0.2098
|
-0.613 mcg/L
Standard Deviation 0.0643
|
0.083 mcg/L
Standard Deviation 0.1193
|
-0.283 mcg/L
Standard Deviation 0.6940
|
5.300 mcg/L
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
—
|
—
|
-0.183 mcg/L
Standard Deviation 0.8073
|
|
Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints
Day 1: 3 hours post-dose
|
0.870 mcg/L
Standard Deviation 0.2343
|
-0.057 mcg/L
Standard Deviation 0.9869
|
-0.040 mcg/L
Standard Deviation 0.2862
|
-0.983 mcg/L
Standard Deviation 0.7184
|
-0.827 mcg/L
Standard Deviation 0.4311
|
-0.655 mcg/L
Standard Deviation 0.0071
|
0.023 mcg/L
Standard Deviation 0.0681
|
-0.153 mcg/L
Standard Deviation 0.4864
|
11.300 mcg/L
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
—
|
—
|
-0.219 mcg/L
Standard Deviation 1.3316
|
|
Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints
Day 1: 5 hours post-dose
|
-0.027 mcg/L
Standard Deviation 0.0379
|
4.413 mcg/L
Standard Deviation 9.3654
|
-0.067 mcg/L
Standard Deviation 0.3150
|
-1.140 mcg/L
Standard Deviation 1.2813
|
-0.317 mcg/L
Standard Deviation 0.3281
|
-0.485 mcg/L
Standard Deviation 0.2475
|
0.127 mcg/L
Standard Deviation 0.1115
|
-0.183 mcg/L
Standard Deviation 0.4491
|
4.102 mcg/L
Standard Deviation 6.1943
|
-0.177 mcg/L
Standard Deviation 0.7212
|
0.410 mcg/L
Standard Deviation 0.3996
|
-0.176 mcg/L
Standard Deviation 1.0820
|
|
Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints
Day 1: 8 hours post-dose
|
—
|
—
|
—
|
—
|
0.710 mcg/L
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
-0.445 mcg/L
Standard Deviation 0.3041
|
0.013 mcg/L
Standard Deviation 0.0231
|
-0.275 mcg/L
Standard Deviation 0.7237
|
7.700 mcg/L
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
—
|
—
|
-0.130 mcg/L
Standard Deviation 0.4181
|
|
Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints
Day 1: 12 hours post-dose
|
—
|
—
|
—
|
—
|
-0.680 mcg/L
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
-0.605 mcg/L
Standard Deviation 0.0778
|
0.210 mcg/L
Standard Deviation 0.3637
|
-0.220 mcg/L
Standard Deviation 0.7804
|
-4.413 mcg/L
Standard Deviation 6.3713
|
0.035 mcg/L
Standard Deviation 0.7219
|
0.043 mcg/L
Standard Deviation 0.4466
|
-0.044 mcg/L
Standard Deviation 0.6347
|
|
Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints
Day 2: 24 hours post-dose
|
0.907 mcg/L
Standard Deviation 0.6881
|
0.730 mcg/L
Standard Deviation 2.6751
|
0.003 mcg/L
Standard Deviation 0.6153
|
2.713 mcg/L
Standard Deviation 4.5502
|
3.717 mcg/L
Standard Deviation 3.8882
|
-0.670 mcg/L
Standard Deviation 0.0141
|
0.190 mcg/L
Standard Deviation 0.3291
|
-0.233 mcg/L
Standard Deviation 0.7781
|
0.767 mcg/L
Standard Deviation 9.8244
|
0.425 mcg/L
Standard Deviation 0.8435
|
-0.380 mcg/L
Standard Deviation 0.5027
|
-0.015 mcg/L
Standard Deviation 0.5437
|
|
Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints
Day 3: 48 hours post-dose
|
0.987 mcg/L
Standard Deviation 0.9901
|
1.077 mcg/L
Standard Deviation 3.6656
|
0.360 mcg/L
Standard Deviation 0.4004
|
0.833 mcg/L
Standard Deviation 3.0087
|
2.043 mcg/L
Standard Deviation 2.4110
|
-0.403 mcg/L
Standard Deviation 0.3194
|
0.197 mcg/L
Standard Deviation 0.3406
|
-0.062 mcg/L
Standard Deviation 0.8170
|
-0.142 mcg/L
Standard Deviation 8.3021
|
-0.235 mcg/L
Standard Deviation 0.6678
|
-0.143 mcg/L
Standard Deviation 0.2658
|
0.312 mcg/L
Standard Deviation 0.5937
|
|
Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints
Day 4: 72 hours post-dose
|
0.290 mcg/L
Standard Deviation 1.3130
|
3.907 mcg/L
Standard Deviation 6.9842
|
-0.107 mcg/L
Standard Deviation 0.5805
|
0.257 mcg/L
Standard Deviation 1.7737
|
1.617 mcg/L
Standard Deviation 0.8663
|
-0.423 mcg/L
Standard Deviation 0.3927
|
0.163 mcg/L
Standard Deviation 0.2829
|
-0.282 mcg/L
Standard Deviation 0.7349
|
-0.327 mcg/L
Standard Deviation 9.5142
|
-0.383 mcg/L
Standard Deviation 0.9286
|
0.473 mcg/L
Standard Deviation 0.9347
|
0.398 mcg/L
Standard Deviation 1.5906
|
|
Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints
Day 5: 96 hours post-dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10.166 mcg/L
Standard Deviation 15.4306
|
-0.452 mcg/L
Standard Deviation 0.7897
|
-0.293 mcg/L
Standard Deviation 0.6240
|
-0.307 mcg/L
Standard Deviation 0.4571
|
|
Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints
Day 8: 168 hours post-dose
|
3.230 mcg/L
Standard Deviation 6.0836
|
-1.280 mcg/L
Standard Deviation 1.1086
|
-0.323 mcg/L
Standard Deviation 0.7149
|
-0.667 mcg/L
Standard Deviation 0.7332
|
0.330 mcg/L
Standard Deviation 0.1015
|
-0.643 mcg/L
Standard Deviation 0.0153
|
0.027 mcg/L
Standard Deviation 0.0462
|
0.217 mcg/L
Standard Deviation 0.3525
|
13.542 mcg/L
Standard Deviation 20.3702
|
-0.284 mcg/L
Standard Deviation 0.4548
|
-0.150 mcg/L
Standard Deviation 0.6874
|
0.001 mcg/L
Standard Deviation 1.7010
|
|
Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints
Day 15: 336 hours post-dose
|
2.023 mcg/L
Standard Deviation 1.8553
|
2.310 mcg/L
Standard Deviation 4.7039
|
-0.287 mcg/L
Standard Deviation 0.7174
|
-0.067 mcg/L
Standard Deviation 1.1829
|
0.930 mcg/L
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
-0.550 mcg/L
Standard Deviation 0.1273
|
0.000 mcg/L
Standard Deviation 0.0000
|
2.898 mcg/L
Standard Deviation 7.8222
|
-11.698 mcg/L
Standard Deviation 14.0227
|
-0.703 mcg/L
Standard Deviation 1.9050
|
0.257 mcg/L
Standard Deviation 1.0000
|
0.081 mcg/L
Standard Deviation 1.1008
|
SECONDARY outcome
Timeframe: Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts.Population: All enrolled subjects treated who had at least 1 measurement of the exploratory endpoints of interest. "Number Analyzed" in each row will be 0 if no participant had at least 1 measurement of the exploratory endpoints of interest within the specified timeframe.
Bb was one of the complement components/biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
Outcome measures
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
n=3 Participants
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
n=3 Participants
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
n=6 Participants
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
n=3 Participants
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
n=16 Participants
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints
Day 1: 12 hours post-dose
|
—
|
—
|
—
|
—
|
0.830 milligrams per liter (mg/L)
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
0.145 milligrams per liter (mg/L)
Standard Deviation 0.2051
|
0.097 milligrams per liter (mg/L)
Standard Deviation 0.5154
|
-0.318 milligrams per liter (mg/L)
Standard Deviation 1.8083
|
0.198 milligrams per liter (mg/L)
Standard Deviation 0.1277
|
0.775 milligrams per liter (mg/L)
Standard Deviation 0.5881
|
0.523 milligrams per liter (mg/L)
Standard Deviation 0.5636
|
-0.015 milligrams per liter (mg/L)
Standard Deviation 0.2355
|
|
Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints
Day 3: 48 hours post-dose
|
-0.273 milligrams per liter (mg/L)
Standard Deviation 0.0802
|
-0.230 milligrams per liter (mg/L)
Standard Deviation 0.3974
|
0.023 milligrams per liter (mg/L)
Standard Deviation 0.0252
|
-0.617 milligrams per liter (mg/L)
Standard Deviation 1.1825
|
0.257 milligrams per liter (mg/L)
Standard Deviation 0.4532
|
0.320 milligrams per liter (mg/L)
Standard Deviation 0.5632
|
0.127 milligrams per liter (mg/L)
Standard Deviation 0.6966
|
0.090 milligrams per liter (mg/L)
Standard Deviation 1.5773
|
0.255 milligrams per liter (mg/L)
Standard Deviation 0.2673
|
0.312 milligrams per liter (mg/L)
Standard Deviation 0.5293
|
0.203 milligrams per liter (mg/L)
Standard Deviation 0.2050
|
0.156 milligrams per liter (mg/L)
Standard Deviation 0.7536
|
|
Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints
Day 36: 840 hours post-dose
|
-0.250 milligrams per liter (mg/L)
Standard Deviation 0.2951
|
-0.387 milligrams per liter (mg/L)
Standard Deviation 0.4382
|
-0.107 milligrams per liter (mg/L)
Standard Deviation 0.3235
|
-0.700 milligrams per liter (mg/L)
Standard Deviation 1.0522
|
—
|
0.360 milligrams per liter (mg/L)
Standard Deviation 0.4525
|
0.450 milligrams per liter (mg/L)
Standard Deviation 0.9617
|
-1.018 milligrams per liter (mg/L)
Standard Deviation 1.6763
|
0.890 milligrams per liter (mg/L)
Standard Deviation 1.0579
|
-0.040 milligrams per liter (mg/L)
Standard Deviation 0.2539
|
0.163 milligrams per liter (mg/L)
Standard Deviation 0.2329
|
0.266 milligrams per liter (mg/L)
Standard Deviation 0.4960
|
|
Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints
Day 1: 1 hour post-dose
|
0.277 milligrams per liter (mg/L)
Standard Deviation 0.2574
|
0.177 milligrams per liter (mg/L)
Standard Deviation 0.1106
|
0.680 milligrams per liter (mg/L)
Standard Deviation 0.1735
|
1.897 milligrams per liter (mg/L)
Standard Deviation 1.4677
|
3.713 milligrams per liter (mg/L)
Standard Deviation 1.2371
|
4.130 milligrams per liter (mg/L)
Standard Deviation 0.4888
|
-0.073 milligrams per liter (mg/L)
Standard Deviation 0.1563
|
-0.518 milligrams per liter (mg/L)
Standard Deviation 1.1527
|
0.000 milligrams per liter (mg/L)
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
—
|
—
|
0.132 milligrams per liter (mg/L)
Standard Deviation 0.2589
|
|
Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints
Day 1: 3 hours post-dose
|
0.057 milligrams per liter (mg/L)
Standard Deviation 0.3636
|
0.253 milligrams per liter (mg/L)
Standard Deviation 0.0473
|
0.593 milligrams per liter (mg/L)
Standard Deviation 0.1943
|
0.977 milligrams per liter (mg/L)
Standard Deviation 0.9903
|
3.920 milligrams per liter (mg/L)
Standard Deviation 1.6404
|
2.850 milligrams per liter (mg/L)
Standard Deviation 0.1838
|
0.117 milligrams per liter (mg/L)
Standard Deviation 0.2011
|
-0.015 milligrams per liter (mg/L)
Standard Deviation 0.7729
|
0.120 milligrams per liter (mg/L)
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
—
|
—
|
0.175 milligrams per liter (mg/L)
Standard Deviation 0.3925
|
|
Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints
Day 1: 5 hours post-dose
|
-0.117 milligrams per liter (mg/L)
Standard Deviation 0.3980
|
-0.243 milligrams per liter (mg/L)
Standard Deviation 0.3557
|
0.117 milligrams per liter (mg/L)
Standard Deviation 0.1150
|
0.260 milligrams per liter (mg/L)
Standard Deviation 0.2762
|
2.313 milligrams per liter (mg/L)
Standard Deviation 2.3526
|
1.355 milligrams per liter (mg/L)
Standard Deviation 0.0636
|
0.163 milligrams per liter (mg/L)
Standard Deviation 0.1626
|
-0.253 milligrams per liter (mg/L)
Standard Deviation 1.4442
|
0.048 milligrams per liter (mg/L)
Standard Deviation 0.0560
|
1.013 milligrams per liter (mg/L)
Standard Deviation 0.8021
|
0.673 milligrams per liter (mg/L)
Standard Deviation 0.5974
|
0.031 milligrams per liter (mg/L)
Standard Deviation 0.2548
|
|
Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints
Day 1: 8 hours post-dose
|
—
|
—
|
—
|
—
|
1.670 milligrams per liter (mg/L)
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
0.375 milligrams per liter (mg/L)
Standard Deviation 0.3889
|
0.067 milligrams per liter (mg/L)
Standard Deviation 0.3308
|
-0.432 milligrams per liter (mg/L)
Standard Deviation 1.5607
|
0.240 milligrams per liter (mg/L)
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
—
|
—
|
0.030 milligrams per liter (mg/L)
Standard Deviation 0.2307
|
|
Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints
Day 2: 24 hours post-dose
|
-0.360 milligrams per liter (mg/L)
Standard Deviation 0.1637
|
-0.097 milligrams per liter (mg/L)
Standard Deviation 0.3465
|
-0.233 milligrams per liter (mg/L)
Standard Deviation 0.4041
|
-0.577 milligrams per liter (mg/L)
Standard Deviation 1.0866
|
0.377 milligrams per liter (mg/L)
Standard Deviation 0.5680
|
0.315 milligrams per liter (mg/L)
Standard Deviation 0.4455
|
0.030 milligrams per liter (mg/L)
Standard Deviation 0.5565
|
-0.322 milligrams per liter (mg/L)
Standard Deviation 1.6140
|
0.220 milligrams per liter (mg/L)
Standard Deviation 0.2082
|
0.908 milligrams per liter (mg/L)
Standard Deviation 1.2157
|
0.413 milligrams per liter (mg/L)
Standard Deviation 0.3602
|
-0.016 milligrams per liter (mg/L)
Standard Deviation 0.4309
|
|
Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints
Day 4: 72 hours post-dose
|
-0.133 milligrams per liter (mg/L)
Standard Deviation 0.3057
|
0.437 milligrams per liter (mg/L)
Standard Deviation 0.2318
|
-0.127 milligrams per liter (mg/L)
Standard Deviation 0.2194
|
-0.640 milligrams per liter (mg/L)
Standard Deviation 1.1521
|
0.153 milligrams per liter (mg/L)
Standard Deviation 0.8702
|
0.100 milligrams per liter (mg/L)
Standard Deviation 0.3219
|
0.100 milligrams per liter (mg/L)
Standard Deviation 0.3260
|
0.082 milligrams per liter (mg/L)
Standard Deviation 0.4979
|
0.335 milligrams per liter (mg/L)
Standard Deviation 0.2649
|
0.250 milligrams per liter (mg/L)
Standard Deviation 0.3824
|
0.160 milligrams per liter (mg/L)
Standard Deviation 0.1600
|
0.196 milligrams per liter (mg/L)
Standard Deviation 0.5920
|
|
Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints
Day 5: 96 hours post-dose
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.372 milligrams per liter (mg/L)
Standard Deviation 0.4206
|
-0.016 milligrams per liter (mg/L)
Standard Deviation 0.5003
|
0.053 milligrams per liter (mg/L)
Standard Deviation 0.0462
|
-0.018 milligrams per liter (mg/L)
Standard Deviation 0.7665
|
|
Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints
Day 8: 168 hours post-dose
|
-0.423 milligrams per liter (mg/L)
Standard Deviation 0.0961
|
-0.217 milligrams per liter (mg/L)
Standard Deviation 0.3121
|
-0.067 milligrams per liter (mg/L)
Standard Deviation 0.1155
|
-0.657 milligrams per liter (mg/L)
Standard Deviation 1.0185
|
0.110 milligrams per liter (mg/L)
Standard Deviation 0.3772
|
0.083 milligrams per liter (mg/L)
Standard Deviation 0.2940
|
-0.050 milligrams per liter (mg/L)
Standard Deviation 0.2787
|
-0.047 milligrams per liter (mg/L)
Standard Deviation 0.7904
|
0.158 milligrams per liter (mg/L)
Standard Deviation 0.3306
|
-0.522 milligrams per liter (mg/L)
Standard Deviation 0.5220
|
0.057 milligrams per liter (mg/L)
Standard Deviation 0.0981
|
0.187 milligrams per liter (mg/L)
Standard Deviation 0.5747
|
|
Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints
Day 15: 336 hours post-dose
|
-0.020 milligrams per liter (mg/L)
Standard Deviation 0.5429
|
-0.100 milligrams per liter (mg/L)
Standard Deviation 0.4911
|
-0.157 milligrams per liter (mg/L)
Standard Deviation 0.2714
|
-0.820 milligrams per liter (mg/L)
Standard Deviation 1.3516
|
-0.280 milligrams per liter (mg/L)
Standard Deviation NA
Standard deviaiton is not calculable for 1 value.
|
-0.025 milligrams per liter (mg/L)
Standard Deviation 0.0354
|
-0.090 milligrams per liter (mg/L)
Standard Deviation 0.0707
|
-0.377 milligrams per liter (mg/L)
Standard Deviation 1.4630
|
0.126 milligrams per liter (mg/L)
Standard Deviation 0.2881
|
-0.445 milligrams per liter (mg/L)
Standard Deviation 0.6457
|
0.583 milligrams per liter (mg/L)
Standard Deviation 1.0104
|
0.137 milligrams per liter (mg/L)
Standard Deviation 0.4811
|
|
Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints
Day 71: 1680 hours post-dose
|
—
|
—
|
—
|
—
|
—
|
—
|
2.067 milligrams per liter (mg/L)
Standard Deviation 2.8386
|
-1.165 milligrams per liter (mg/L)
Standard Deviation 2.2748
|
0.818 milligrams per liter (mg/L)
Standard Deviation 0.5851
|
-0.466 milligrams per liter (mg/L)
Standard Deviation 0.4039
|
0.193 milligrams per liter (mg/L)
Standard Deviation 0.3349
|
0.058 milligrams per liter (mg/L)
Standard Deviation 0.5159
|
Adverse Events
Cohort 1: PF-06755347 0.01 mg/kg IV
Cohort 2: PF-06755347 0.03 mg/kg IV
Cohort 3: PF-06755347 0.1 mg/kg IV
Cohort 4: PF-06755347 0.3 mg/kg IV
Cohort 5: PF-06755347 1 mg/kg IV
Cohort 6: PF-06755347 0.7 mg/kg IV
Cohort 7: PF-06755347 25 mg SC
Cohort 8: PF-06755347 50 mg SC
Cohort 9: PF-06755347 100 mg SC
Cohort 10: PF-06755347 200 mg SC
Cohort 11: PF-06755347 300 mg SC
Placebo
Serious adverse events
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 participants at risk
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=3 participants at risk
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=3 participants at risk
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=3 participants at risk
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 participants at risk
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
n=3 participants at risk
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
n=3 participants at risk
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
n=6 participants at risk
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
n=6 participants at risk
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
n=6 participants at risk
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
n=3 participants at risk
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
n=16 participants at risk
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
Other adverse events
| Measure |
Cohort 1: PF-06755347 0.01 mg/kg IV
n=3 participants at risk
Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1.
|
Cohort 2: PF-06755347 0.03 mg/kg IV
n=3 participants at risk
Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1.
|
Cohort 3: PF-06755347 0.1 mg/kg IV
n=3 participants at risk
Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1.
|
Cohort 4: PF-06755347 0.3 mg/kg IV
n=3 participants at risk
Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1.
|
Cohort 5: PF-06755347 1 mg/kg IV
n=3 participants at risk
Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1.
|
Cohort 6: PF-06755347 0.7 mg/kg IV
n=3 participants at risk
Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1.
|
Cohort 7: PF-06755347 25 mg SC
n=3 participants at risk
Healthy participants received single dose of PF-06755347 25 mg SC on Day 1.
|
Cohort 8: PF-06755347 50 mg SC
n=6 participants at risk
Healthy participants received single dose of PF-06755347 50 mg SC on Day 1.
|
Cohort 9: PF-06755347 100 mg SC
n=6 participants at risk
Healthy participants received single dose of PF-06755347 100 mg SC on Day 1.
|
Cohort 10: PF-06755347 200 mg SC
n=6 participants at risk
Healthy participants received single dose of PF-06755347 200 mg SC on Day 1.
|
Cohort 11: PF-06755347 300 mg SC
n=3 participants at risk
Healthy participants received single dose of PF-06755347 300 mg SC on Day 1.
|
Placebo
n=16 participants at risk
Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Asthenia
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
6.2%
1/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
6.2%
1/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
6.2%
1/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
6.2%
1/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
6.2%
1/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
100.0%
3/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
General disorders
Administration site erythema
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
2/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
General disorders
Application site irritation
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
General disorders
Catheter site haematoma
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
6.2%
1/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
General disorders
Discomfort
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
6.2%
1/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
18.8%
3/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
General disorders
Feeling cold
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
66.7%
2/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
General disorders
Feeling hot
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
General disorders
Infusion site haemorrhage
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
General disorders
Injection site bruising
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
General disorders
Injection site erythema
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
66.7%
2/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
83.3%
5/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
2/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
66.7%
2/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
General disorders
Injection site induration
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
General disorders
Injection site pain
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
General disorders
Injection site pruritus
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
General disorders
Injection site reaction
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
General disorders
Injection site swelling
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
General disorders
Mass
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
General disorders
Pain
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
General disorders
Swelling
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
66.7%
2/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
6.2%
1/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
66.7%
2/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
6.2%
1/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
6.2%
1/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
6.2%
1/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Investigations
Body temperature
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Investigations
Electrocardiogram PR prolongation
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
2/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
6.2%
1/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
6.2%
1/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
66.7%
2/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
2/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
6.2%
1/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
6.2%
1/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
6.2%
1/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Reproductive system and breast disorders
Penile erythema
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Reproductive system and breast disorders
Perineal swelling
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
12.5%
2/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Skin and subcutaneous tissue disorders
Skin depigmentation
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
16.7%
1/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
33.3%
1/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/6 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/3 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/16 • Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before the participants participation in the study (ie, before undergoing any study related procedure and/or receiving investigational product), through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60