Trial Outcomes & Findings for A Study of Single and Multiple Doses of ALXN1210 in Healthy, Adult Japanese Participants (NCT NCT05288816)
NCT ID: NCT05288816
Last Updated: 2024-02-05
Results Overview
An adverse event (AE) was defined as any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or procedure, whether or not considered related to the medicinal product or procedure, which occurred during the course of the clinical study. TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. 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
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
Results posted on
2024-02-05
Participant Flow
Participant milestones
| Measure |
Cohort 1: ALXN1210 400 mg Single Dose
Participants received a single dose of ALXN1210 400 milligrams (mg), via intravenous (IV) infusion on Day 1. Participants were followed for 120 days.
|
Cohort 2: ALXN1210 800 mg Single Dose
Participants received a single dose of ALXN1210 800 mg, via IV infusion on Day 1. Participants were followed for 140 days.
|
Cohort 3: ALXN1210 800 mg Multiple Dose
Participants received multiple doses of ALXN1210 800 mg, via IV infusion every 4 weeks (on Days 1, 29, 57, 85, and 113) for a total of 5 doses. Participants were followed for 185 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
8
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
4
|
4
|
8
|
|
Overall Study
COMPLETED
|
4
|
4
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Single and Multiple Doses of ALXN1210 in Healthy, Adult Japanese Participants
Baseline characteristics by cohort
| Measure |
Cohort 1: ALXN1210 400 mg Single Dose
n=4 Participants
Participants received a single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed for 120 days.
|
Cohort 2: ALXN1210 800 mg Single Dose
n=4 Participants
Participants received a single dose of ALXN1210 800 mg, via IV infusion on Day 1. Participants were followed for 140 days.
|
Cohort 3: ALXN1210 800 mg Multiple Dose
n=8 Participants
Participants received multiple doses of ALXN1210 800 mg, via IV infusion every 4 weeks (on Days 1, 29, 57, 85, and 113) for a total of 5 doses. Participants were followed for 185 days.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32.8 years
STANDARD_DEVIATION 7.32 • n=5 Participants
|
35.0 years
STANDARD_DEVIATION 8.72 • n=7 Participants
|
30.9 years
STANDARD_DEVIATION 4.32 • n=5 Participants
|
32.4 years
STANDARD_DEVIATION 6.14 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298Population: The safety population consisted of all participants who received at least 1 dose of study drug.
An adverse event (AE) was defined as any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or procedure, whether or not considered related to the medicinal product or procedure, which occurred during the course of the clinical study. TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. 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: ALXN1210 400 mg Single Dose
n=4 Participants
Participants received a single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed for 120 days.
|
Cohort 2: ALXN1210 800 mg Single Dose
n=4 Participants
Participants received a single dose of ALXN1210 800 mg, via IV infusion on Day 1. Participants were followed for 140 days.
|
Cohort 3: ALXN1210 800 mg Multiple Dose
n=8 Participants
Participants received multiple doses of ALXN1210 800 mg, via IV infusion every 4 weeks (on Days 1, 29, 57, 85, and 113) for a total of 5 doses. Participants were followed for 185 days.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
2 Participants
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298Population: The immunogenicity analysis population consisted of all participants who had a pre-dose and post-dose ADA samples collected.
Blood samples were collected to evaluate antibody response through development of ADAs.
Outcome measures
| Measure |
Cohort 1: ALXN1210 400 mg Single Dose
n=4 Participants
Participants received a single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed for 120 days.
|
Cohort 2: ALXN1210 800 mg Single Dose
n=4 Participants
Participants received a single dose of ALXN1210 800 mg, via IV infusion on Day 1. Participants were followed for 140 days.
|
Cohort 3: ALXN1210 800 mg Multiple Dose
n=8 Participants
Participants received multiple doses of ALXN1210 800 mg, via IV infusion every 4 weeks (on Days 1, 29, 57, 85, and 113) for a total of 5 doses. Participants were followed for 185 days.
|
|---|---|---|---|
|
Number of Participants With Anti-Drug Antibodies (ADAs) To ALXN1210
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Cohort 1: Baseline (pre-dose) up to Day 120; Cohort 2: Baseline (pre-dose) up to Day 140Population: The pharmacokinetic (PK) population consisted of all participants who had sufficient serum concentration data to enable the calculation of PK parameters.
Blood samples were collected for estimation of AUCinf using Phoenix WinNonlin software version 7.0.
Outcome measures
| Measure |
Cohort 1: ALXN1210 400 mg Single Dose
n=4 Participants
Participants received a single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed for 120 days.
|
Cohort 2: ALXN1210 800 mg Single Dose
n=4 Participants
Participants received a single dose of ALXN1210 800 mg, via IV infusion on Day 1. Participants were followed for 140 days.
|
Cohort 3: ALXN1210 800 mg Multiple Dose
Participants received multiple doses of ALXN1210 800 mg, via IV infusion every 4 weeks (on Days 1, 29, 57, 85, and 113) for a total of 5 doses. Participants were followed for 185 days.
|
|---|---|---|---|
|
Area Under The Serum Concentration Versus Time Curve From Time Zero To Infinity (AUCinf) For Single Dose of ALXN1210
|
102361.591 hour*microgram/milliliter (hr*mcg/mL)
Standard Deviation 22918.174
|
261313.227 hour*microgram/milliliter (hr*mcg/mL)
Standard Deviation 16016.673
|
—
|
SECONDARY outcome
Timeframe: Day 113 (pre-dose) up to Day 298Population: The PK population consisted of all participants who had sufficient serum concentration data to enable the calculation of PK parameters.
Blood samples were collected for estimation of AUCinf using Phoenix WinNonlin software version 7.0.
Outcome measures
| Measure |
Cohort 1: ALXN1210 400 mg Single Dose
n=8 Participants
Participants received a single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed for 120 days.
|
Cohort 2: ALXN1210 800 mg Single Dose
Participants received a single dose of ALXN1210 800 mg, via IV infusion on Day 1. Participants were followed for 140 days.
|
Cohort 3: ALXN1210 800 mg Multiple Dose
Participants received multiple doses of ALXN1210 800 mg, via IV infusion every 4 weeks (on Days 1, 29, 57, 85, and 113) for a total of 5 doses. Participants were followed for 185 days.
|
|---|---|---|---|
|
Area Under The Serum Concentration Versus Time Curve From Time Zero To Infinity (AUCinf) For Multiple Dose of ALXN1210
|
499626.032 hr*mcg/mL
Standard Deviation 116203.665
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 1: Baseline (pre-dose) up to Day 120; Cohort 2: Baseline (pre-dose) up to Day 140Population: The PK population consisted of all participants who had sufficient serum concentration data to enable the calculation of PK parameters.
Blood samples were collected for estimation of Cmax using Phoenix WinNonlin software version 7.0.
Outcome measures
| Measure |
Cohort 1: ALXN1210 400 mg Single Dose
n=4 Participants
Participants received a single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed for 120 days.
|
Cohort 2: ALXN1210 800 mg Single Dose
n=4 Participants
Participants received a single dose of ALXN1210 800 mg, via IV infusion on Day 1. Participants were followed for 140 days.
|
Cohort 3: ALXN1210 800 mg Multiple Dose
Participants received multiple doses of ALXN1210 800 mg, via IV infusion every 4 weeks (on Days 1, 29, 57, 85, and 113) for a total of 5 doses. Participants were followed for 185 days.
|
|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) For Single Dose of ALXN1210
|
174.750 micrograms/milliliter
Standard Deviation 25.316
|
397.750 micrograms/milliliter
Standard Deviation 25.526
|
—
|
SECONDARY outcome
Timeframe: Day 113 (pre-dose) up to Day 298Population: The PK population consisted of all participants who had sufficient serum concentration data to enable the calculation of PK parameters.
Blood samples were collected for estimation of Cmax using Phoenix WinNonlin software version 7.0.
Outcome measures
| Measure |
Cohort 1: ALXN1210 400 mg Single Dose
n=8 Participants
Participants received a single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed for 120 days.
|
Cohort 2: ALXN1210 800 mg Single Dose
Participants received a single dose of ALXN1210 800 mg, via IV infusion on Day 1. Participants were followed for 140 days.
|
Cohort 3: ALXN1210 800 mg Multiple Dose
Participants received multiple doses of ALXN1210 800 mg, via IV infusion every 4 weeks (on Days 1, 29, 57, 85, and 113) for a total of 5 doses. Participants were followed for 185 days.
|
|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) For Multiple Dose of ALXN1210
|
565.625 mcg/mL
Standard Deviation 76.651
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 1 (end of infusion)Population: The pharmacodynamic (PD) population consisted of all participants who had sufficient total and free C5 concentration data and chicken red blood cells (cRBC) hemolysis data.
Outcome measures
| Measure |
Cohort 1: ALXN1210 400 mg Single Dose
n=4 Participants
Participants received a single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed for 120 days.
|
Cohort 2: ALXN1210 800 mg Single Dose
n=4 Participants
Participants received a single dose of ALXN1210 800 mg, via IV infusion on Day 1. Participants were followed for 140 days.
|
Cohort 3: ALXN1210 800 mg Multiple Dose
Participants received multiple doses of ALXN1210 800 mg, via IV infusion every 4 weeks (on Days 1, 29, 57, 85, and 113) for a total of 5 doses. Participants were followed for 185 days.
|
|---|---|---|---|
|
Percent Change From Baseline in Free Complement Protein C5 Concentration at Day 1
|
-99.7762 percent change
Standard Deviation 0.0617
|
-99.8920 percent change
Standard Deviation 0.0333
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 113 (end of infusion)Population: The PD population consisted of all participants who had sufficient total and free C5 concentration data and cRBC hemolysis data.
Outcome measures
| Measure |
Cohort 1: ALXN1210 400 mg Single Dose
n=8 Participants
Participants received a single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed for 120 days.
|
Cohort 2: ALXN1210 800 mg Single Dose
Participants received a single dose of ALXN1210 800 mg, via IV infusion on Day 1. Participants were followed for 140 days.
|
Cohort 3: ALXN1210 800 mg Multiple Dose
Participants received multiple doses of ALXN1210 800 mg, via IV infusion every 4 weeks (on Days 1, 29, 57, 85, and 113) for a total of 5 doses. Participants were followed for 185 days.
|
|---|---|---|---|
|
Percent Change From Baseline in Free Complement Protein C5 Concentration at Day 113
|
-99.5724 percent change
Standard Deviation 0.0492
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 1 (end of infusion)Population: The PD population consisted of all participants who had sufficient total and free C5 concentration data and cRBC hemolysis data.
Outcome measures
| Measure |
Cohort 1: ALXN1210 400 mg Single Dose
n=4 Participants
Participants received a single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed for 120 days.
|
Cohort 2: ALXN1210 800 mg Single Dose
n=4 Participants
Participants received a single dose of ALXN1210 800 mg, via IV infusion on Day 1. Participants were followed for 140 days.
|
Cohort 3: ALXN1210 800 mg Multiple Dose
Participants received multiple doses of ALXN1210 800 mg, via IV infusion every 4 weeks (on Days 1, 29, 57, 85, and 113) for a total of 5 doses. Participants were followed for 185 days.
|
|---|---|---|---|
|
Percent Change From Baseline in Total C5 Concentration at Day 1
|
-5.0810 percent change
Standard Deviation 4.7737
|
-5.5713 percent change
Standard Deviation 2.6475
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 113 (end of infusion)Population: The PD population consisted of all participants who had sufficient total and free C5 concentration data and cRBC hemolysis data.
Outcome measures
| Measure |
Cohort 1: ALXN1210 400 mg Single Dose
n=8 Participants
Participants received a single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed for 120 days.
|
Cohort 2: ALXN1210 800 mg Single Dose
Participants received a single dose of ALXN1210 800 mg, via IV infusion on Day 1. Participants were followed for 140 days.
|
Cohort 3: ALXN1210 800 mg Multiple Dose
Participants received multiple doses of ALXN1210 800 mg, via IV infusion every 4 weeks (on Days 1, 29, 57, 85, and 113) for a total of 5 doses. Participants were followed for 185 days.
|
|---|---|---|---|
|
Percent Change From Baseline in Total C5 Concentration at Day 113
|
-8.3487 percent change
Standard Deviation 3.5507
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 1 (end of infusion)Population: The PD population consisted of all participants who had sufficient total and free C5 concentration data and cRBC hemolysis data.
Outcome measures
| Measure |
Cohort 1: ALXN1210 400 mg Single Dose
n=4 Participants
Participants received a single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed for 120 days.
|
Cohort 2: ALXN1210 800 mg Single Dose
n=4 Participants
Participants received a single dose of ALXN1210 800 mg, via IV infusion on Day 1. Participants were followed for 140 days.
|
Cohort 3: ALXN1210 800 mg Multiple Dose
Participants received multiple doses of ALXN1210 800 mg, via IV infusion every 4 weeks (on Days 1, 29, 57, 85, and 113) for a total of 5 doses. Participants were followed for 185 days.
|
|---|---|---|---|
|
Percent Change From Baseline in Chicken Red Blood Cell Hemolysis at Day 1
|
-98.9905 percent change
Standard Deviation 1.8232
|
-98.5454 percent change
Standard Deviation 2.2934
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 113 (end of infusion)Population: The PD population consisted of all participants who had sufficient total and free C5 concentration data and cRBC hemolysis data.
Outcome measures
| Measure |
Cohort 1: ALXN1210 400 mg Single Dose
n=8 Participants
Participants received a single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed for 120 days.
|
Cohort 2: ALXN1210 800 mg Single Dose
Participants received a single dose of ALXN1210 800 mg, via IV infusion on Day 1. Participants were followed for 140 days.
|
Cohort 3: ALXN1210 800 mg Multiple Dose
Participants received multiple doses of ALXN1210 800 mg, via IV infusion every 4 weeks (on Days 1, 29, 57, 85, and 113) for a total of 5 doses. Participants were followed for 185 days.
|
|---|---|---|---|
|
Percent Change From Baseline in Chicken Red Blood Cell Hemolysis at Day 113
|
-97.8156 percent change
Standard Deviation 2.9408
|
—
|
—
|
Adverse Events
Cohort 1: ALXN1210 400 mg Single Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2: ALXN1210 800 mg Single Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3: ALXN1210 800 mg Multiple Dose
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: ALXN1210 400 mg Single Dose
n=4 participants at risk
Participants received a single dose of ALXN1210 400 mg, via IV infusion on Day 1. Participants were followed for 120 days.
|
Cohort 2: ALXN1210 800 mg Single Dose
n=4 participants at risk
Participants received a single dose of ALXN1210 800 mg, via IV infusion on Day 1. Participants were followed for 140 days.
|
Cohort 3: ALXN1210 800 mg Multiple Dose
n=8 participants at risk
Participants received multiple doses of ALXN1210 800 mg, via IV infusion every 4 weeks (on Days 1, 29, 57, 85, and 113) for a total of 5 doses. Participants were followed for 185 days.
|
|---|---|---|---|
|
Eye disorders
Eyelids pruritus
|
0.00%
0/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Photopsia
|
25.0%
1/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
25.0%
1/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
1/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
37.5%
3/8 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
25.0%
1/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
37.5%
3/8 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298
The safety population consisted of 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