Trial Outcomes & Findings for A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes Mellitus (NCT NCT02211261)
NCT ID: NCT02211261
Last Updated: 2018-10-16
Results Overview
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 85 (for SAD cohorts) or Day 169 (for MAD cohorts) that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs. Causality with the study treatment was determined by the investigator.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
84 participants
Primary outcome timeframe
Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
Results posted on
2018-10-16
Participant Flow
Participant milestones
| Measure |
Placebo SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
6
|
6
|
6
|
9
|
2
|
6
|
8
|
8
|
16
|
8
|
|
Overall Study
COMPLETED
|
9
|
6
|
5
|
6
|
7
|
1
|
6
|
7
|
8
|
14
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
2
|
1
|
0
|
1
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Placebo SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Placebo SC (SAD Cohorts)
n=9 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
n=9 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
n=2 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
n=8 Participants
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
n=8 Participants
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
n=16 Participants
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
n=8 Participants
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
<18 years
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=40 Participants
|
0 participants
n=8 Participants
|
0 participants
n=62 Participants
|
0 participants
n=95 Participants
|
0 participants
n=129 Participants
|
|
Age, Customized
18-44 years
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
1 participants
n=36 Participants
|
1 participants
n=10 Participants
|
1 participants
n=115 Participants
|
0 participants
n=40 Participants
|
0 participants
n=8 Participants
|
0 participants
n=62 Participants
|
0 participants
n=95 Participants
|
3 participants
n=129 Participants
|
|
Age, Customized
45-64 years
|
7 participants
n=93 Participants
|
4 participants
n=4 Participants
|
4 participants
n=27 Participants
|
6 participants
n=483 Participants
|
6 participants
n=36 Participants
|
1 participants
n=10 Participants
|
5 participants
n=115 Participants
|
7 participants
n=40 Participants
|
4 participants
n=8 Participants
|
9 participants
n=62 Participants
|
8 participants
n=95 Participants
|
61 participants
n=129 Participants
|
|
Age, Customized
>=65 years
|
2 participants
n=93 Participants
|
2 participants
n=4 Participants
|
2 participants
n=27 Participants
|
0 participants
n=483 Participants
|
2 participants
n=36 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
1 participants
n=40 Participants
|
4 participants
n=8 Participants
|
7 participants
n=62 Participants
|
0 participants
n=95 Participants
|
20 participants
n=129 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
3 Participants
n=8 Participants
|
9 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
34 Participants
n=129 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=62 Participants
|
7 Participants
n=95 Participants
|
50 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
4 Participants
n=8 Participants
|
7 Participants
n=62 Participants
|
7 Participants
n=95 Participants
|
46 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
6 Participants
n=40 Participants
|
4 Participants
n=8 Participants
|
9 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
38 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
PRIMARY outcome
Timeframe: Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.Population: The safety analysis population included all participants who received any amount of dose of study medication.
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 85 (for SAD cohorts) or Day 169 (for MAD cohorts) that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs. Causality with the study treatment was determined by the investigator.
Outcome measures
| Measure |
Placebo SC (SAD Cohorts)
n=9 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
n=9 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
n=2 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
n=8 Participants
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
n=8 Participants
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
n=16 Participants
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
n=8 Participants
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With All-Causality and Treatment Related Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events
All-causality SAE
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
|
Number of Participants With All-Causality and Treatment Related Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events
All-causality AE
|
5 participants
|
3 participants
|
3 participants
|
5 participants
|
5 participants
|
0 participants
|
3 participants
|
4 participants
|
4 participants
|
11 participants
|
8 participants
|
|
Number of Participants With All-Causality and Treatment Related Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events
Treatment-related AE
|
1 participants
|
0 participants
|
0 participants
|
3 participants
|
3 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
4 participants
|
5 participants
|
|
Number of Participants With All-Causality and Treatment Related Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events
Treatment-related SAE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD CohortsPopulation: Data for this outcome measure were not collected.
Dose limiting or intolerable AEs were originally planned to be collected. However, this outcome measure was not actually summarized, since collection and monitoring of treatment-emergent AEs was performed during the study, and deemed sufficient to ensure the participants safety.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD CohortsPopulation: The safety analysis population included all participants who received any amount of dose of study medication.
ADA against PF-06293620 in human serum samples was determined following a tiered approach using screening, confirmation, and titer/quantification by semi-quantitative enzyme linked immunosorbent assay (ELISA). Endpoint titer \>=1.88 was considered positive.
Outcome measures
| Measure |
Placebo SC (SAD Cohorts)
n=9 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
n=9 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
n=2 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
n=8 Participants
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
n=8 Participants
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
n=16 Participants
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
n=8 Participants
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Anti-drug Antibody (ADA) Result
|
1 participants
|
5 participants
|
2 participants
|
1 participants
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
5 participants
|
7 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85Population: The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
AUCinf was calculated as AUClast +(Clast\*/kel), where AUClast is area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis, kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Outcome measures
| Measure |
Placebo SC (SAD Cohorts)
n=1 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
n=5 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
n=7 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06293620 (SAD Cohorts)
|
300 microgram*hour/milliliter (mcg*hr/mL)
Geometric Coefficient of Variation NA
Only 1 participant had reportable value, geometric coefficient of variation is not applicable.
|
1716 microgram*hour/milliliter (mcg*hr/mL)
Geometric Coefficient of Variation 46
|
6306 microgram*hour/milliliter (mcg*hr/mL)
Geometric Coefficient of Variation 54
|
19440 microgram*hour/milliliter (mcg*hr/mL)
Geometric Coefficient of Variation 56
|
6775 microgram*hour/milliliter (mcg*hr/mL)
Geometric Coefficient of Variation 12
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85Population: The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
AUCinf(dn) was calculated as AUCinf/dose, where AUCinf is area under the serum concentration-time profile from time 0 extrapolated to infinite time.
Outcome measures
| Measure |
Placebo SC (SAD Cohorts)
n=1 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
n=5 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
n=7 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose-normalized AUCinf (AUCinf(dn)) of PF-06293620 (SAD Cohorts)
|
12.00 mcg*hr/mL/mg
Geometric Coefficient of Variation NA
Only 1 participant had reportable value, geometric coefficient of variation is not applicable.
|
22.24 mcg*hr/mL/mg
Geometric Coefficient of Variation 45
|
23.79 mcg*hr/mL/mg
Geometric Coefficient of Variation 47
|
36.13 mcg*hr/mL/mg
Geometric Coefficient of Variation 49
|
67.94 mcg*hr/mL/mg
Geometric Coefficient of Variation 16
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85Population: The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) of PF-06293620 was determined using linear/log trapezoidal method.
Outcome measures
| Measure |
Placebo SC (SAD Cohorts)
n=5 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
n=5 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
n=7 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06293620 (SAD Cohorts)
|
128.3 mcg*hr/mL
Geometric Coefficient of Variation 54
|
1619 mcg*hr/mL
Geometric Coefficient of Variation 46
|
5945 mcg*hr/mL
Geometric Coefficient of Variation 53
|
18080 mcg*hr/mL
Geometric Coefficient of Variation 58
|
6509 mcg*hr/mL
Geometric Coefficient of Variation 13
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85Population: The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
AUClast(dn) of PF-06293620 was calculated as AUClast/dose, where AUClast was area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration.
Outcome measures
| Measure |
Placebo SC (SAD Cohorts)
n=5 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
n=5 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
n=7 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose-normalized AUClast (AUClast(dn)) of PF-06293620 (SAD Cohorts)
|
4.779 mcg*hr/mL/mg
Geometric Coefficient of Variation 58
|
21.01 mcg*hr/mL/mg
Geometric Coefficient of Variation 44
|
22.47 mcg*hr/mL/mg
Geometric Coefficient of Variation 47
|
33.59 mcg*hr/mL/mg
Geometric Coefficient of Variation 50
|
65.26 mcg*hr/mL/mg
Geometric Coefficient of Variation 18
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85Population: The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Clearance (CL) was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to IV arms.
Outcome measures
| Measure |
Placebo SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Clearance (CL) of PF-06293620 (SAD Cohorts)
|
14.72 mL/hr
Geometric Coefficient of Variation 16
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85Population: The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Apparent Clearance (CL/F) of PF-06293620 was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to SC arms.
Outcome measures
| Measure |
Placebo SC (SAD Cohorts)
n=1 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
n=5 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
n=7 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of PF-06293620 (SAD Cohorts)
|
83.20 mL/hr
Geometric Coefficient of Variation NA
Only 1 participant had reportable value, geometric coefficient of variation is not applicable.
|
44.93 mL/hr
Geometric Coefficient of Variation 45
|
42.05 mL/hr
Geometric Coefficient of Variation 47
|
27.67 mL/hr
Geometric Coefficient of Variation 49
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85Population: The pharmacokinetic (PK) concentration population included all enrolled participants treated who had at least 1 measurable (greater than lower limit of quantification) concentration value.
Maximum serum concentration (Cmax) of PF-06293620 was observed directly from data.
Outcome measures
| Measure |
Placebo SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
n=5 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
n=7 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of PF-06293620 (SAD Cohorts)
|
0.3907 mcg/mL
Geometric Coefficient of Variation 58
|
2.896 mcg/mL
Geometric Coefficient of Variation 48
|
7.222 mcg/mL
Geometric Coefficient of Variation 52
|
22.30 mcg/mL
Geometric Coefficient of Variation 62
|
27.64 mcg/mL
Geometric Coefficient of Variation 20
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85Population: The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Time for Maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence.
Outcome measures
| Measure |
Placebo SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
n=5 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
n=7 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time for Maximum Serum Concentration (Tmax) of PF-06293620 (SAD Cohorts)
|
168 hours
Full Range 58 • Interval 71.9 to 336.0
|
168 hours
Full Range 48 • Interval 48.0 to 504.0
|
252 hours
Full Range 52 • Interval 95.9 to 504.0
|
168 hours
Full Range 62 • Interval 96.0 to 504.0
|
1.00 hours
Full Range 20 • Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85Population: The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Steady-state volume of distribution (Vss) of PF-06293620 was calculated as CL\*MRT, where MRT was the mean residence time calculated as (AUMCinf/AUCinf - infusion duration/2), AUMCinf was area under the moment curve from time 0 extrapolated to infinity; CL was the clearance. This outcome measure only applies to IV arms.
Outcome measures
| Measure |
Placebo SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Steady-state Volume of Distribution (Vss) of PF-06293620 (SAD Cohorts)
|
7.095 liters
Geometric Coefficient of Variation 21 • Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85Population: The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Apparent Volume of Distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCinf\*kel), where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time, kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. This outcome measure only applies to SC arms.
Outcome measures
| Measure |
Placebo SC (SAD Cohorts)
n=1 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
n=5 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
n=7 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of PF-06293620 (SAD Cohorts)
|
21.10 liters
Geometric Coefficient of Variation NA
Only 1 participant had reportable value, geometric coefficient of variation is not applicable.
|
16.25 liters
Geometric Coefficient of Variation 43
|
20.63 liters
Geometric Coefficient of Variation 44
|
18.17 liters
Geometric Coefficient of Variation 48
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85Population: The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Terminal elimination half-life (Thalf) of PF-06293620 was calculated as ln(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Outcome measures
| Measure |
Placebo SC (SAD Cohorts)
n=1 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
n=5 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
n=7 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
n=6 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half-life (Thalf) of PF-06293620 (SAD Cohorts)
|
7.33 days
Standard Deviation NA
Only 1 participant had reportable value, geometric coefficient of variation is not applicable.
|
10.95 days
Standard Deviation 3.74
|
14.66 days
Standard Deviation 4.21
|
19.23 days
Standard Deviation 3.45
|
14.37 days
Standard Deviation 3.13
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169Population: The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Tau refers to the dosing interval, which was 4 weeks (672 hours). Area under the concentration-time profile from time 0 to time tau (AUCtau) was determined using linear/log trapezoidal method.
Outcome measures
| Measure |
Placebo SC (SAD Cohorts)
n=8 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
n=16 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
n=8 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Day 1
|
609.6 mcg*hr/mL
Geometric Coefficient of Variation 137
|
802.5 mcg*hr/mL
Geometric Coefficient of Variation 79
|
2752 mcg*hr/mL
Geometric Coefficient of Variation 73
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Day 57
|
1309 mcg*hr/mL
Geometric Coefficient of Variation 60
|
2991 mcg*hr/mL
Geometric Coefficient of Variation 57
|
6121 mcg*hr/mL
Geometric Coefficient of Variation 48
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169Population: The PK concentration population included all enrolled participants treated who had at least 1 measurable concentration value.
Outcome measures
| Measure |
Placebo SC (SAD Cohorts)
n=8 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
n=16 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
n=8 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Day 57
|
1.989 mcg/mL
Geometric Coefficient of Variation 183
|
6.012 mcg/mL
Geometric Coefficient of Variation 65
|
11.74 mcg/mL
Geometric Coefficient of Variation 56
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Day 1
|
1.526 mcg/mL
Geometric Coefficient of Variation 139
|
1.706 mcg/mL
Geometric Coefficient of Variation 72
|
5.184 mcg/mL
Geometric Coefficient of Variation 73
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169Population: The PK concentration population included all enrolled participants treated who had at least 1 measurable concentration value.
Average Concentration (Cav) of PF-06293620 was calculated as AUCtau/tau, where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours).
Outcome measures
| Measure |
Placebo SC (SAD Cohorts)
n=8 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
n=16 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
n=8 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Average Concentration (Cav) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Day 1
|
0.9067 mcg/mL
Geometric Coefficient of Variation 137
|
1.194 mcg/mL
Geometric Coefficient of Variation 79
|
4.096 mcg/mL
Geometric Coefficient of Variation 73
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Average Concentration (Cav) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Day 57
|
1.948 mcg/mL
Geometric Coefficient of Variation 60
|
4.449 mcg/mL
Geometric Coefficient of Variation 57
|
9.102 mcg/mL
Geometric Coefficient of Variation 48
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169Population: The pharmacokinetic (PK) concentration population included all enrolled participants treated who had at least 1 measurable (greater than lower limit of quantification) concentration value.
Outcome measures
| Measure |
Placebo SC (SAD Cohorts)
n=7 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
n=14 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
n=7 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-06293620 (MAD Cohorts) After Day 57 Administration
|
0.7555 µg/mL
Geometric Coefficient of Variation 94
|
1.979 µg/mL
Geometric Coefficient of Variation 72
|
5.456 µg/mL
Geometric Coefficient of Variation 48
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169Population: The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Time for maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence.
Outcome measures
| Measure |
Placebo SC (SAD Cohorts)
n=8 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
n=16 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
n=8 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time for Maximum Serum Concentration (Tmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Day 57
|
168 hours
Interval 47.8 to 192.0
|
144 hours
Interval 47.5 to 648.0
|
120 hours
Interval 48.0 to 504.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time for Maximum Serum Concentration (Tmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Day 1
|
240 hours
Interval 144.0 to 338.0
|
252 hours
Interval 48.0 to 338.0
|
360 hours
Interval 144.0 to 648.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169Population: The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Apparent clearance (CL/F) of PF-06293620 was calculated as dose/AUCtau, where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours).
Outcome measures
| Measure |
Placebo SC (SAD Cohorts)
n=7 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
n=14 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
n=7 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration
|
38.19 mL/hr
Geometric Coefficient of Variation 60
|
25.07 mL/hr
Geometric Coefficient of Variation 57
|
24.53 mL/hr
Geometric Coefficient of Variation 47
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169Population: The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Apparent volume of distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCtau/kel), where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours); and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Outcome measures
| Measure |
Placebo SC (SAD Cohorts)
n=7 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
n=14 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
n=7 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration
|
13.43 liters
Geometric Coefficient of Variation 38
|
10.45 liters
Geometric Coefficient of Variation 52
|
12.09 liters
Geometric Coefficient of Variation 40
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169Population: The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Terminal elimination half-life (Thalf) of PF-06293620 was calculated as ln(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Outcome measures
| Measure |
Placebo SC (SAD Cohorts)
n=7 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
n=14 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
n=7 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half-life (Thalf) of PF-06293620 (MAD Cohorts) After Day 57 Administration
|
10.37 days
Standard Deviation 2.22
|
12.72 days
Standard Deviation 4.21
|
14.50 days
Standard Deviation 2.81
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169Population: The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Observed accumulation ratio based on AUC (Rac) of PF-06293620 was calculated as AUCtau(Day57)/AUCtau(Day1).
Outcome measures
| Measure |
Placebo SC (SAD Cohorts)
n=7 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
n=14 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
n=7 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Observed Accumulation Ratio Based on AUC (Rac) of PF-06293620 (MAD Cohorts)
|
1.833 ratio
Geometric Coefficient of Variation 64
|
3.446 ratio
Geometric Coefficient of Variation 36
|
2.148 ratio
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169Population: The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Observed accumulation ratio based on Cmax (Rac,Cmax) of PF-06293620 was calculated as Cmax(Day57)/Cmax(Day1).
Outcome measures
| Measure |
Placebo SC (SAD Cohorts)
n=8 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
n=14 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
n=7 Participants
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Observed Accumulation Ratio Based on Cmax (Rac,Cmax) of PF-06293620 (MAD Cohorts)
|
1.302 ratio
Geometric Coefficient of Variation 114
|
3.257 ratio
Geometric Coefficient of Variation 42
|
2.188 ratio
Geometric Coefficient of Variation 22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo SC (SAD Cohorts)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo IV (SAD Cohorts)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo SC (MAD Cohorts)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
PF-06293620 50 mg SC (MAD Cohorts)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
PF-06293620 75 mg SC (MAD Cohorts)
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
PF-06293620 150 mg SC (MAD Cohorts)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo SC (SAD Cohorts)
n=9 participants at risk
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
n=6 participants at risk
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
n=6 participants at risk
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
n=6 participants at risk
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
n=9 participants at risk
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
n=2 participants at risk
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
n=6 participants at risk
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
n=8 participants at risk
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
n=8 participants at risk
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
n=16 participants at risk
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
n=8 participants at risk
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
6.2%
1/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
Other adverse events
| Measure |
Placebo SC (SAD Cohorts)
n=9 participants at risk
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 0.3 mg/kg SC (SAD Cohorts)
n=6 participants at risk
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg SC (SAD Cohorts)
n=6 participants at risk
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 3.0 mg/kg SC (SAD Cohorts)
n=6 participants at risk
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 6.0 mg/kg SC (SAD Cohorts)
n=9 participants at risk
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
Placebo IV (SAD Cohorts)
n=2 participants at risk
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
PF-06293620 1.0 mg/kg IV (SAD Cohorts)
n=6 participants at risk
One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.
|
Placebo SC (MAD Cohorts)
n=8 participants at risk
One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 50 mg SC (MAD Cohorts)
n=8 participants at risk
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 75 mg SC (MAD Cohorts)
n=16 participants at risk
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
PF-06293620 150 mg SC (MAD Cohorts)
n=8 participants at risk
One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
1/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
37.5%
3/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
6.2%
1/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
11.1%
1/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
6.2%
1/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Gastrointestinal disorders
Diarrhoea
|
22.2%
2/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
50.0%
3/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
2/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
11.1%
1/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
6.2%
1/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
General disorders
Asthenia
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
General disorders
Hunger
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
General disorders
Infusion site hemorrhage
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
General disorders
Injection site pruritus
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
6.2%
1/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
General disorders
Malaise
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
6.2%
1/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
6.2%
1/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Infections and infestations
Body tinea
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
11.1%
1/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
6.2%
1/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
11.1%
1/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Infections and infestations
Infective glossitis
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Infections and infestations
Influenza
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
6.2%
1/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
6.2%
1/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Infections and infestations
Viral infection
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
6.2%
1/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Investigations
Blood pressure increased
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
11.1%
1/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
6.2%
1/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Investigations
Liver function test increased
|
11.1%
1/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
22.2%
2/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
6.2%
1/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
62.5%
5/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
6.2%
1/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
6.2%
1/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
6.2%
1/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue swelling
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
11.1%
1/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
6.2%
1/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
11.1%
1/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
6.2%
1/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Skin and subcutaneous tissue disorders
Diabetic dermopathy
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
22.2%
2/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
33.3%
2/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Vascular disorders
Hypertension
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
12.5%
1/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
3/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
11.1%
1/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
11.1%
1/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/9 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/2 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
16.7%
1/6 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/16 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
0.00%
0/8 • Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER