Trial Outcomes & Findings for A Study of ALXN1830 in Healthy Adult Participants (NCT NCT04730804)
NCT ID: NCT04730804
Last Updated: 2024-09-19
Results Overview
An AE was any untoward medical occurrence in a participant administered the study drug and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as an AE with a start date or time on or after the first dose of the study intervention. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
Day 1 (postdose) through follow-up (up to approximately 141 days)
Results posted on
2024-09-19
Participant Flow
A total of 34 participants (25 ALXN1830 treated and 9 placebo-treated) were enrolled and randomized in a 6:2 ratio in 5 cohorts. Healthy, Japanese participants were planned to be dosed in Cohort 6 according to the highest tolerated dose (HTD) established in the non-Japanese cohorts. This cohort was not achieved due to early termination of the study.
Participant milestones
| Measure |
Cohort 1: ALXN1830 Single Medium Dose
Participants received a single subcutaneous (SC) medium dose of ALXN1830.
|
Cohort 2: ALXN1830 Single Hign Dose
Participants received a single SC high dose of ALXN1830.
|
Cohort 3: ALXN1830 Multiple Low Dose
Participants received multiple SC low doses of ALXN1830 once weekly (QW).
|
Cohort 4: ALXN1830 Multiple Medium Dose
Participants received multiple SC medium doses of ALXN1830 QW.
|
Cohort 5: ALXN1830 Multiple High Dose
Participants received multiple SC high doses of ALXN1830 QW.
|
Placebo
Participants received placebo matched to ALXN1830.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
1
|
6
|
6
|
6
|
9
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
6
|
1
|
6
|
6
|
6
|
9
|
|
Overall Study
COMPLETED
|
6
|
1
|
6
|
6
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
3
|
Reasons for withdrawal
| Measure |
Cohort 1: ALXN1830 Single Medium Dose
Participants received a single subcutaneous (SC) medium dose of ALXN1830.
|
Cohort 2: ALXN1830 Single Hign Dose
Participants received a single SC high dose of ALXN1830.
|
Cohort 3: ALXN1830 Multiple Low Dose
Participants received multiple SC low doses of ALXN1830 once weekly (QW).
|
Cohort 4: ALXN1830 Multiple Medium Dose
Participants received multiple SC medium doses of ALXN1830 QW.
|
Cohort 5: ALXN1830 Multiple High Dose
Participants received multiple SC high doses of ALXN1830 QW.
|
Placebo
Participants received placebo matched to ALXN1830.
|
|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
2
|
Baseline Characteristics
A Study of ALXN1830 in Healthy Adult Participants
Baseline characteristics by cohort
| Measure |
Cohort 1: ALXN1830 Single Medium Dose
n=6 Participants
Participants received a single SC medium dose of ALXN1830.
|
Cohort 2: ALXN1830 Single High Dose
n=1 Participants
Participants received a single SC high dose of ALXN1830.
|
Cohort 3: ALXN1830 Multiple Low Dose
n=6 Participants
Participants received multiple SC low doses of ALXN1830 QW.
|
Cohort 4: ALXN1830 Multiple Medium Dose
n=6 Participants
Participants received multiple SC medium doses of ALXN1830 QW.
|
Cohort 5: ALXN1830 Multiple High Dose
n=6 Participants
Participants received multiple SC high doses of ALXN1830 QW.
|
Placebo
n=9 Participants
Participants received placebo matched to ALXN1830.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
34 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race · Asian Indian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race · Chinese
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race · Other Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race · Samoan
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race · Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not of Hispanic, Latino/a, or Spanish origin
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Another Hispanic, Latino/a, or Spanish origin
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1 (postdose) through follow-up (up to approximately 141 days)Population: The Safety Set included all participants who received at least 1 dose of study drug.
An AE was any untoward medical occurrence in a participant administered the study drug and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as an AE with a start date or time on or after the first dose of the study intervention. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
Cohort 1: ALXN1830 Single Medium Dose
n=6 Participants
Participants received a single SC medium dose of ALXN1830.
|
Cohort 2: ALXN1830 Single High Dose
n=1 Participants
Participants received a single SC high dose of ALXN1830.
|
Cohort 3: ALXN1830 Multiple Low Dose
n=6 Participants
Participants received multiple SC low doses of ALXN1830 QW.
|
Cohort 4: ALXN1830 Multiple Medium Dose
n=6 Participants
Participants received multiple SC medium doses of ALXN1830 QW.
|
Cohort 5: ALXN1830 Multiple High Dose
n=6 Participants
Participants received multiple SC high doses of ALXN1830 QW.
|
Placebo
n=9 Participants
Participants received placebo matched to ALXN1830.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
6 Participants
|
1 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 1 (predose) up to Day 64 (postdose)Population: The Pharmacokinetic Set included all participants who received at least 1 dose of study drug (only active) and had at least 1 postdose serum ALXN1830 concentration measured. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Serum total drug concentrations were measured using a validated liquid chromatography/mass spectrometry (LC/MS) assay.
Outcome measures
| Measure |
Cohort 1: ALXN1830 Single Medium Dose
n=1 Participants
Participants received a single SC medium dose of ALXN1830.
|
Cohort 2: ALXN1830 Single High Dose
n=1 Participants
Participants received a single SC high dose of ALXN1830.
|
Cohort 3: ALXN1830 Multiple Low Dose
Participants received multiple SC low doses of ALXN1830 QW.
|
Cohort 4: ALXN1830 Multiple Medium Dose
Participants received multiple SC medium doses of ALXN1830 QW.
|
Cohort 5: ALXN1830 Multiple High Dose
Participants received multiple SC high doses of ALXN1830 QW.
|
Placebo
Participants received placebo matched to ALXN1830.
|
|---|---|---|---|---|---|---|
|
Single-Dose Cohorts: Area Under the Serum Concentration-time Curve From Time 0 (Dosing) To Time Infinity (AUC0-inf) of ALXN1830
|
360.940 hours*milligram (mg)/liter (L)
|
291.930 hours*milligram (mg)/liter (L)
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (predose up to 12 hours postdose)Population: The Pharmacokinetic Set included all participants who received at least 1 dose of study drug (only active) and had at least 1 postdose serum ALXN1830 concentration measured. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. Per prespecified analysis, only participants in Cohort 5 were analyzed for this outcome measure.
Serum total drug concentrations were measured using a validated LC/MS assay.
Outcome measures
| Measure |
Cohort 1: ALXN1830 Single Medium Dose
Participants received a single SC medium dose of ALXN1830.
|
Cohort 2: ALXN1830 Single High Dose
Participants received a single SC high dose of ALXN1830.
|
Cohort 3: ALXN1830 Multiple Low Dose
n=4 Participants
Participants received multiple SC low doses of ALXN1830 QW.
|
Cohort 4: ALXN1830 Multiple Medium Dose
Participants received multiple SC medium doses of ALXN1830 QW.
|
Cohort 5: ALXN1830 Multiple High Dose
Participants received multiple SC high doses of ALXN1830 QW.
|
Placebo
Participants received placebo matched to ALXN1830.
|
|---|---|---|---|---|---|---|
|
Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 1
|
—
|
—
|
340.085 hours*mg/L
Standard Deviation 162.0531
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 22 (predose up to 12 hours postdose)Population: The Pharmacokinetic Set included all participants who received at least 1 dose of study drug (only active) and had at least 1 postdose serum ALXN1830 concentration measured. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. Per prespecified analysis, only participants in Cohort 4 were analyzed for this outcome measure.
Serum total drug concentrations were measured using a validated LC/MS assay.
Outcome measures
| Measure |
Cohort 1: ALXN1830 Single Medium Dose
Participants received a single SC medium dose of ALXN1830.
|
Cohort 2: ALXN1830 Single High Dose
n=3 Participants
Participants received a single SC high dose of ALXN1830.
|
Cohort 3: ALXN1830 Multiple Low Dose
Participants received multiple SC low doses of ALXN1830 QW.
|
Cohort 4: ALXN1830 Multiple Medium Dose
Participants received multiple SC medium doses of ALXN1830 QW.
|
Cohort 5: ALXN1830 Multiple High Dose
Participants received multiple SC high doses of ALXN1830 QW.
|
Placebo
Participants received placebo matched to ALXN1830.
|
|---|---|---|---|---|---|---|
|
Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 22
|
—
|
333.787 hours*mg/L
Standard Deviation 143.7390
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 78 (predose up to 12 hours postdose)Population: The Pharmacokinetic Set included all participants who received at least 1 dose of study drug (only active) and had at least 1 postdose serum ALXN1830 concentration measured. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. Per prespecified analysis, only participants in Cohort 3 were analyzed for this outcome measure.
Serum total drug concentrations were measured using a validated LC/MS assay.
Outcome measures
| Measure |
Cohort 1: ALXN1830 Single Medium Dose
n=1 Participants
Participants received a single SC medium dose of ALXN1830.
|
Cohort 2: ALXN1830 Single High Dose
Participants received a single SC high dose of ALXN1830.
|
Cohort 3: ALXN1830 Multiple Low Dose
Participants received multiple SC low doses of ALXN1830 QW.
|
Cohort 4: ALXN1830 Multiple Medium Dose
Participants received multiple SC medium doses of ALXN1830 QW.
|
Cohort 5: ALXN1830 Multiple High Dose
Participants received multiple SC high doses of ALXN1830 QW.
|
Placebo
Participants received placebo matched to ALXN1830.
|
|---|---|---|---|---|---|---|
|
Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 78
|
847.380 hours*mg/L
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, early termination visit (up to Day 141)Population: The Pharmacodynamic Set included all participants who received at least 1 dose of study drug (active and placebo) who had evaluable serum Immunoglobulin data (IgG, IgG subtypes, Ig subtypes, and circulating immune complexes \[CIC\]) or neonatal crystallizable fragment receptor (FcRn) data.
Serum concentration of IgG was measured using validated nephelometric assays.
Outcome measures
| Measure |
Cohort 1: ALXN1830 Single Medium Dose
n=6 Participants
Participants received a single SC medium dose of ALXN1830.
|
Cohort 2: ALXN1830 Single High Dose
n=1 Participants
Participants received a single SC high dose of ALXN1830.
|
Cohort 3: ALXN1830 Multiple Low Dose
n=6 Participants
Participants received multiple SC low doses of ALXN1830 QW.
|
Cohort 4: ALXN1830 Multiple Medium Dose
n=6 Participants
Participants received multiple SC medium doses of ALXN1830 QW.
|
Cohort 5: ALXN1830 Multiple High Dose
n=6 Participants
Participants received multiple SC high doses of ALXN1830 QW.
|
Placebo
n=9 Participants
Participants received placebo matched to ALXN1830.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Serum Immunoglobulin G (IgG) at Early Termination Visit (up to Day 141)
|
-0.60 grams (g)/L
Standard Deviation 1.037
|
-1.00 grams (g)/L
|
-0.22 grams (g)/L
Standard Deviation 1.504
|
-0.70 grams (g)/L
Standard Deviation 0.899
|
0.10 grams (g)/L
Standard Deviation 0.555
|
-0.17 grams (g)/L
Standard Deviation 1.122
|
SECONDARY outcome
Timeframe: Day 120Population: The Pharmacodynamic Set included all participants who received at least 1 dose of study drug (active and placebo) who had evaluable serum Immunoglobulin data (IgG, IgG subtypes, Ig subtypes, and CIC) or FcRn data. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Outcome measures
| Measure |
Cohort 1: ALXN1830 Single Medium Dose
Participants received a single SC medium dose of ALXN1830.
|
Cohort 2: ALXN1830 Single High Dose
Participants received a single SC high dose of ALXN1830.
|
Cohort 3: ALXN1830 Multiple Low Dose
n=6 Participants
Participants received multiple SC low doses of ALXN1830 QW.
|
Cohort 4: ALXN1830 Multiple Medium Dose
Participants received multiple SC medium doses of ALXN1830 QW.
|
Cohort 5: ALXN1830 Multiple High Dose
Participants received multiple SC high doses of ALXN1830 QW.
|
Placebo
n=1 Participants
Participants received placebo matched to ALXN1830.
|
|---|---|---|---|---|---|---|
|
Percent FcRN Receptor Occupancy at Day 120
|
—
|
—
|
12.07 percentage of receptor occupied
Geometric Coefficient of Variation 92.0
|
—
|
—
|
6.40 percentage of receptor occupied
|
SECONDARY outcome
Timeframe: Day 1 (postdose) through follow-up (up to approximately 141 days)Population: The Immunogenicity Set included all participants who had a predose (baseline) and at least 1 postdose ADA sample collected.
Outcome measures
| Measure |
Cohort 1: ALXN1830 Single Medium Dose
n=6 Participants
Participants received a single SC medium dose of ALXN1830.
|
Cohort 2: ALXN1830 Single High Dose
n=1 Participants
Participants received a single SC high dose of ALXN1830.
|
Cohort 3: ALXN1830 Multiple Low Dose
n=6 Participants
Participants received multiple SC low doses of ALXN1830 QW.
|
Cohort 4: ALXN1830 Multiple Medium Dose
n=6 Participants
Participants received multiple SC medium doses of ALXN1830 QW.
|
Cohort 5: ALXN1830 Multiple High Dose
n=6 Participants
Participants received multiple SC high doses of ALXN1830 QW.
|
Placebo
n=9 Participants
Participants received placebo matched to ALXN1830.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Antidrug Antibodies (ADA) and Neutralizing Antibodies (NAb) to ALXN1830
ADA positive
|
6 Participants
|
1 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Antidrug Antibodies (ADA) and Neutralizing Antibodies (NAb) to ALXN1830
NAb
|
4 Participants
|
0 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
Cohort 1: ALXN1830 Single Medium Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2: ALXN1830 Single High Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3: ALXN1830 Multiple Low Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 4: ALXN1830 Multiple Medium Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 5: ALXN1830 Multiple High Dose
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: ALXN1830 Single Medium Dose
n=6 participants at risk
Participants received a single SC medium dose of ALXN1830.
|
Cohort 2: ALXN1830 Single High Dose
n=1 participants at risk
Participants received a single SC high dose of ALXN1830.
|
Cohort 3: ALXN1830 Multiple Low Dose
n=6 participants at risk
Participants received multiple SC low doses of ALXN1830 QW.
|
Cohort 4: ALXN1830 Multiple Medium Dose
n=6 participants at risk
Participants received multiple SC medium doses of ALXN1830 QW.
|
Cohort 5: ALXN1830 Multiple High Dose
n=6 participants at risk
Participants received multiple SC high doses of ALXN1830 QW.
|
Placebo
n=9 participants at risk
Participants received placebo matched to ALXN1830.
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Phlebitis
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Eye pain
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Weight increased
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site erythema
|
33.3%
2/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
100.0%
1/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
83.3%
5/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
100.0%
6/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site pain
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
100.0%
1/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
50.0%
3/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
50.0%
3/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site swelling
|
66.7%
4/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
100.0%
1/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site bruising
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site induration
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site pruritus
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
50.0%
3/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Catheter site pain
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Catheter site vesicles
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Chest discomfort
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Feeling abnormal
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site discomfort
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site inflammation
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site paraesthesia
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site urticaria
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Mass
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Medical device site reaction
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
50.0%
3/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
66.7%
4/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
33.3%
3/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Tension headache
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
50.0%
3/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Acarodermatitis
|
33.3%
2/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gonorrhoea
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
50.0%
3/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Salivary gland pain
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
50.0%
3/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
11.1%
1/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/1 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
22.2%
2/9 • Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included all participants who received at least 1 dose of study drug.
|
Additional Information
Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
Phone: 855-752-2356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place