Trial Outcomes & Findings for Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN1910 in Healthy Participants (NCT NCT05307978)
NCT ID: NCT05307978
Last Updated: 2025-02-27
Results Overview
The safety and tolerability of ALXN1910 was assessed.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Day 1 (postdose) through Day 75
Results posted on
2025-02-27
Participant Flow
Subjects who met all the inclusion and none of the exclusion criteria were randomized in 1 site. The study was conducted from 12 Apr 2022 to 07 Feb 2023.
The screening period was up to 28 days. Informed consent form (ICF) was signed prior to screening procedures. Subjects received study drug in a randomised order. All the study assessments were performed as per the schedule of assessment.
Participant milestones
| Measure |
Cohort 1- 5 mg
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
12
|
|
Overall Study
COMPLETED
|
6
|
5
|
6
|
2
|
6
|
6
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
4
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1- 5 mg
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
4
|
0
|
0
|
1
|
Baseline Characteristics
Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN1910 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Cohort 1- 5 mg
n=6 Participants
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=6 Participants
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
n=6 Participants
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
n=6 Participants
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
n=6 Participants
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
n=6 Participants
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
n=12 Participants
Participants received a single dose of matching Placebo IV or SC.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Age
|
37.7 Years
STANDARD_DEVIATION 9.69 • n=5 Participants
|
33.0 Years
STANDARD_DEVIATION 13.75 • n=7 Participants
|
35.3 Years
STANDARD_DEVIATION 8.89 • n=5 Participants
|
31.8 Years
STANDARD_DEVIATION 7.65 • n=4 Participants
|
30.2 Years
STANDARD_DEVIATION 4.40 • n=21 Participants
|
34.0 Years
STANDARD_DEVIATION 7.85 • n=8 Participants
|
33.6 Years
STANDARD_DEVIATION 6.27 • n=8 Participants
|
33.6 Years
STANDARD_DEVIATION 8.19 • n=24 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
18 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
30 Participants
n=24 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
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
45 Participants
n=24 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
9 Participants
n=24 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
26 Participants
n=24 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Day 1 (postdose) through Day 75Population: All participants who received any amount of study intervention were included in the Safety Analysis Set. Participants were analyzed according to the study intervention received.
The safety and tolerability of ALXN1910 was assessed.
Outcome measures
| Measure |
Cohort 1- 5 mg
n=6 Participants
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=6 Participants
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
n=6 Participants
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
n=6 Participants
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
n=6 Participants
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
n=6 Participants
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
n=12 Participants
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Any TEAE
|
3 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
8 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Any Serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAE outcome of Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
AE Leading to Withdrawal of Study Drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
SAE Leading to Withdrawal of Study Drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75Population: All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received
The Cmax was assessed as PK parameter of single ascending doses of ALXN1910.
Outcome measures
| Measure |
Cohort 1- 5 mg
n=6 Participants
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=6 Participants
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
n=6 Participants
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
n=6 Participants
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
n=6 Participants
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
n=6 Participants
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax)
|
1.034 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 16.5
|
0.3172 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 60.3
|
3.113 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 11.5
|
0.3807 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 31.8
|
1.230 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 32.0
|
4.257 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 38.3
|
—
|
SECONDARY outcome
Timeframe: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75Population: All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received
The Tmax was assed as PK parameter of single ascending doses of ALXN1910.
Outcome measures
| Measure |
Cohort 1- 5 mg
n=6 Participants
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=6 Participants
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
n=6 Participants
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
n=6 Participants
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
n=6 Participants
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
n=6 Participants
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
Time to Maximum Observed Serum Concentration (Tmax)
|
0.48 hour (h)
Interval 0.23 to 0.6
|
107.85 hour (h)
Interval 48.01 to 171.5
|
0.52 hour (h)
Interval 0.51 to 0.55
|
108.02 hour (h)
Interval 71.92 to 169.32
|
95.99 hour (h)
Interval 71.89 to 145.03
|
84.14 hour (h)
Interval 48.09 to 142.74
|
—
|
SECONDARY outcome
Timeframe: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75Population: All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received. Here, Number of Participants Analyzed refers to the number of participants available for the specific Outcome measure for analysis.
The t1/2 was assed as PK parameter of single ascending doses of ALXN1910.
Outcome measures
| Measure |
Cohort 1- 5 mg
n=6 Participants
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=4 Participants
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
n=6 Participants
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
n=5 Participants
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
n=5 Participants
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
n=6 Participants
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
Apparent Terminal Elimination Half Life (t1/2)
|
166.1 hour (h)
Geometric Coefficient of Variation 25.1
|
215.1 hour (h)
Geometric Coefficient of Variation 12.2
|
194.9 hour (h)
Geometric Coefficient of Variation 19.2
|
207.5 hour (h)
Geometric Coefficient of Variation 13.9
|
271.3 hour (h)
Geometric Coefficient of Variation 6.0
|
263.5 hour (h)
Geometric Coefficient of Variation 18.8
|
—
|
SECONDARY outcome
Timeframe: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75Population: All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received. Here, Number of Participants Analyzed refers to the number of participants available for the specific Outcome measure for analysis.
The λz was assed as PK parameter of single ascending doses of ALXN1910.
Outcome measures
| Measure |
Cohort 1- 5 mg
n=6 Participants
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=4 Participants
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
n=6 Participants
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
n=5 Participants
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
n=5 Participants
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
n=6 Participants
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
Terminal-phase Elimination Rate Constant (λz)
|
0.004172 1/hour (1/h)
Geometric Coefficient of Variation 25.1
|
0.003222 1/hour (1/h)
Geometric Coefficient of Variation 12.2
|
0.003556 1/hour (1/h)
Geometric Coefficient of Variation 19.2
|
0.003341 1/hour (1/h)
Geometric Coefficient of Variation 13.9
|
0.002555 1/hour (1/h)
Geometric Coefficient of Variation 6.0
|
0.002631 1/hour (1/h)
Geometric Coefficient of Variation 18.8
|
—
|
SECONDARY outcome
Timeframe: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75Population: All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received. Here, Number of Participants Analyzed refers to the number of participants available for the specific Outcome measure for analysis.
The AUCt was assed as PK parameter of single ascending doses of ALXN1910.
Outcome measures
| Measure |
Cohort 1- 5 mg
n=6 Participants
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=6 Participants
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
n=6 Participants
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
n=6 Participants
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
n=5 Participants
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
n=6 Participants
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
AUC From Time Zero to the Last Quantifiable Concentratio (AUCt)
|
69.52 hour*microgram/milliliter (h*μg/mL)
Geometric Coefficient of Variation 23.0
|
102.4 hour*microgram/milliliter (h*μg/mL)
Geometric Coefficient of Variation 44.1
|
219.0 hour*microgram/milliliter (h*μg/mL)
Geometric Coefficient of Variation 14.2
|
120.9 hour*microgram/milliliter (h*μg/mL)
Geometric Coefficient of Variation 30.3
|
484.3 hour*microgram/milliliter (h*μg/mL)
Geometric Coefficient of Variation 13.1
|
1606 hour*microgram/milliliter (h*μg/mL)
Geometric Coefficient of Variation 20.4
|
—
|
SECONDARY outcome
Timeframe: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75Population: All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received. Here, Number of Participants Analyzed refers to the number of participants available for the specific Outcome measure for analysis.
The AUC∞ was assed as PK parameter of single ascending doses of ALXN1910.
Outcome measures
| Measure |
Cohort 1- 5 mg
n=5 Participants
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=3 Participants
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
n=6 Participants
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
n=5 Participants
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
n=5 Participants
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
n=6 Participants
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
AUC From Time Zero Extrapolated to Infinity (AUC∞)
|
89.43 hour*microgram/milliliter (h*μg/mL)
Geometric Coefficient of Variation 22.2
|
168.0 hour*microgram/milliliter (h*μg/mL)
Geometric Coefficient of Variation 20.3
|
244.5 hour*microgram/milliliter (h*μg/mL)
Geometric Coefficient of Variation 13.8
|
157.8 hour*microgram/milliliter (h*μg/mL)
Geometric Coefficient of Variation 23.4
|
517.8 hour*microgram/milliliter (h*μg/mL)
Geometric Coefficient of Variation 12.4
|
1699 hour*microgram/milliliter (h*μg/mL)
Geometric Coefficient of Variation 19.8
|
—
|
SECONDARY outcome
Timeframe: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75Population: All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received.
The AUC0-168 was assed as PK parameter of single ascending doses of ALXN1910.
Outcome measures
| Measure |
Cohort 1- 5 mg
n=6 Participants
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=6 Participants
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
n=6 Participants
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
n=6 Participants
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
n=6 Participants
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
n=6 Participants
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
AUC From Time Zero to 168h (AUC0-168)
|
53.06 hour*microgram/milliliter (h*μg/mL)
Geometric Coefficient of Variation 14.4
|
40.83 hour*microgram/milliliter (h*μg/mL)
Geometric Coefficient of Variation 65.6
|
142.1 hour*microgram/milliliter (h*μg/mL)
Geometric Coefficient of Variation 11.6
|
49.73 hour*microgram/milliliter (h*μg/mL)
Geometric Coefficient of Variation 35.3
|
161.9 hour*microgram/milliliter (h*μg/mL)
Geometric Coefficient of Variation 37.2
|
573.3 hour*microgram/milliliter (h*μg/mL)
Geometric Coefficient of Variation 37.9
|
—
|
SECONDARY outcome
Timeframe: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75Population: All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received. Here, Number of Participants Analyzed refers to the number of participants available for the specific Outcome measure for analysis.
The %AUCex was assed as PK parameter of single ascending doses of ALXN1910.
Outcome measures
| Measure |
Cohort 1- 5 mg
n=6 Participants
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=5 Participants
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
n=6 Participants
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
n=5 Participants
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
n=5 Participants
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
n=6 Participants
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
Percentage of AUC∞ Obtained by Extrapolation Beyond Tlast (%AUCex)
|
24.03 Percentage (%) of AUC∞
Geometric Coefficient of Variation 21.1
|
22.89 Percentage (%) of AUC∞
Geometric Coefficient of Variation 73.2
|
10.41 Percentage (%) of AUC∞
Geometric Coefficient of Variation 5.8
|
16.89 Percentage (%) of AUC∞
Geometric Coefficient of Variation 31.8
|
6.418 Percentage (%) of AUC∞
Geometric Coefficient of Variation 12.5
|
5.133 Percentage (%) of AUC∞
Geometric Coefficient of Variation 39.0
|
—
|
SECONDARY outcome
Timeframe: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75Population: All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received. Here, Number of Participants Analyzed refers to the number of participants available for the specific Outcome measure for analysis.
The CL or CL/F was assed as PK parameter of single ascending doses of ALXN1910.
Outcome measures
| Measure |
Cohort 1- 5 mg
n=5 Participants
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=3 Participants
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
n=6 Participants
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
n=5 Participants
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
n=5 Participants
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
n=6 Participants
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
Total Body Clearance (for IV Cohorts) or Apparent Clearance (for SC Cohorts) (CL or CL/F)
|
0.05591 Liter/hour (L/h)
Geometric Coefficient of Variation 22.2
|
0.08926 Liter/hour (L/h)
Geometric Coefficient of Variation 20.3
|
0.06135 Liter/hour (L/h)
Geometric Coefficient of Variation 13.8
|
0.09507 Liter/hour (L/h)
Geometric Coefficient of Variation 23.4
|
0.08691 Liter/hour (L/h)
Geometric Coefficient of Variation 12.4
|
0.07945 Liter/hour (L/h)
Geometric Coefficient of Variation 19.8
|
—
|
SECONDARY outcome
Timeframe: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75Population: All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received. Here, Number of Participants Analyzed refers to the number of participants available for the specific Outcome measure for analysis.
The Vd or Vd/F was assed as PK parameter of single ascending doses of ALXN1910.
Outcome measures
| Measure |
Cohort 1- 5 mg
n=5 Participants
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=3 Participants
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
n=6 Participants
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
n=5 Participants
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
n=5 Participants
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
n=6 Participants
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
Volume of Distribution (for IV Cohorts) or Apparent Volume of Distribution (for SC Cohorts) (Vd or Vd/F)
|
12.56 Liter (L)
Geometric Coefficient of Variation 11.2
|
27.12 Liter (L)
Geometric Coefficient of Variation 29.4
|
17.25 Liter (L)
Geometric Coefficient of Variation 12.1
|
28.46 Liter (L)
Geometric Coefficient of Variation 21.0
|
34.02 Liter (L)
Geometric Coefficient of Variation 11.3
|
30.20 Liter (L)
Geometric Coefficient of Variation 29.3
|
—
|
SECONDARY outcome
Timeframe: Day 1 (predose), 2, 3, 5, 8, 15, 22, 29, 36, 43, and 75Population: All treated participants for whom the PD profile of ALXN1910 can be adequately characterized were included in the PD Set. Here, Number Analyzed refers to the number of participants available for the specific Outcome measure for specific timeframe.
The plasma concentrations of PPi was assesed.
Outcome measures
| Measure |
Cohort 1- 5 mg
n=6 Participants
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=6 Participants
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
n=6 Participants
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
n=6 Participants
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
n=6 Participants
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
n=6 Participants
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
n=12 Participants
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
Plasma Concentration of Inorganic Pyrophosphate (PPi)
Day 1
|
1.677 micromole/Liter (umol/L)
Standard Deviation 0.6197
|
1.783 micromole/Liter (umol/L)
Standard Deviation 0.5743
|
1.580 micromole/Liter (umol/L)
Standard Deviation 0.2270
|
1.683 micromole/Liter (umol/L)
Standard Deviation 0.2788
|
1.577 micromole/Liter (umol/L)
Standard Deviation 0.2518
|
1.525 micromole/Liter (umol/L)
Standard Deviation 0.2882
|
1.638 micromole/Liter (umol/L)
Standard Deviation 0.3860
|
|
Plasma Concentration of Inorganic Pyrophosphate (PPi)
Day 2
|
1.162 micromole/Liter (umol/L)
Standard Deviation 0.2057
|
1.550 micromole/Liter (umol/L)
Standard Deviation 0.3407
|
0.915 micromole/Liter (umol/L)
Standard Deviation 0.2219
|
1.582 micromole/Liter (umol/L)
Standard Deviation 0.3579
|
1.165 micromole/Liter (umol/L)
Standard Deviation 0.2696
|
0.823 micromole/Liter (umol/L)
Standard Deviation 0.1152
|
1.418 micromole/Liter (umol/L)
Standard Deviation 0.2699
|
|
Plasma Concentration of Inorganic Pyrophosphate (PPi)
Day 3
|
1.152 micromole/Liter (umol/L)
Standard Deviation 0.0719
|
1.303 micromole/Liter (umol/L)
Standard Deviation 0.2728
|
0.950 micromole/Liter (umol/L)
Standard Deviation 0.2134
|
1.405 micromole/Liter (umol/L)
Standard Deviation 0.1733
|
1.093 micromole/Liter (umol/L)
Standard Deviation 0.3075
|
0.778 micromole/Liter (umol/L)
Standard Deviation 0.0694
|
1.408 micromole/Liter (umol/L)
Standard Deviation 0.2405
|
|
Plasma Concentration of Inorganic Pyrophosphate (PPi)
Day 5
|
1.232 micromole/Liter (umol/L)
Standard Deviation 0.1052
|
1.265 micromole/Liter (umol/L)
Standard Deviation 0.2091
|
0.978 micromole/Liter (umol/L)
Standard Deviation 0.2481
|
1.476 micromole/Liter (umol/L)
Standard Deviation 0.4730
|
0.962 micromole/Liter (umol/L)
Standard Deviation 0.2212
|
0.750 micromole/Liter (umol/L)
Standard Deviation 0.750
|
1.509 micromole/Liter (umol/L)
Standard Deviation 0.4246
|
|
Plasma Concentration of Inorganic Pyrophosphate (PPi)
Day 8
|
1.368 micromole/Liter (umol/L)
Standard Deviation 0.1269
|
1.257 micromole/Liter (umol/L)
Standard Deviation 0.2279
|
1.177 micromole/Liter (umol/L)
Standard Deviation 0.3393
|
1.470 micromole/Liter (umol/L)
Standard Deviation 0.2206
|
0.974 micromole/Liter (umol/L)
Standard Deviation 0.1218
|
0.750 micromole/Liter (umol/L)
Standard Deviation 0
|
1.368 micromole/Liter (umol/L)
Standard Deviation 0.3200
|
|
Plasma Concentration of Inorganic Pyrophosphate (PPi)
Day 15
|
1.326 micromole/Liter (umol/L)
Standard Deviation 0.0503
|
1.388 micromole/Liter (umol/L)
Standard Deviation 0.1080
|
1.198 micromole/Liter (umol/L)
Standard Deviation 0.1982
|
1.483 micromole/Liter (umol/L)
Standard Deviation 0.2817
|
0.977 micromole/Liter (umol/L)
Standard Deviation 0.1695
|
0.830 micromole/Liter (umol/L)
Standard Deviation 0.1171
|
1.261 micromole/Liter (umol/L)
Standard Deviation 0.1614
|
|
Plasma Concentration of Inorganic Pyrophosphate (PPi)
Day 22
|
1.424 micromole/Liter (umol/L)
Standard Deviation 0.1036
|
1.356 micromole/Liter (umol/L)
Standard Deviation 0.1195
|
1.350 micromole/Liter (umol/L)
Standard Deviation 0.2692
|
1.558 micromole/Liter (umol/L)
Standard Deviation 0.1855
|
1.134 micromole/Liter (umol/L)
Standard Deviation 0.1828
|
0.875 micromole/Liter (umol/L)
Standard Deviation 0.1524
|
1.328 micromole/Liter (umol/L)
Standard Deviation 0.1873
|
|
Plasma Concentration of Inorganic Pyrophosphate (PPi)
Day 29
|
1.295 micromole/Liter (umol/L)
Standard Deviation 0.1610
|
1.332 micromole/Liter (umol/L)
Standard Deviation 0.2834
|
1.320 micromole/Liter (umol/L)
Standard Deviation 0.1582
|
1.518 micromole/Liter (umol/L)
Standard Deviation 0.0952
|
1.294 micromole/Liter (umol/L)
Standard Deviation 0.1997
|
1.044 micromole/Liter (umol/L)
Standard Deviation 0.1790
|
1.438 micromole/Liter (umol/L)
Standard Deviation 0.2677
|
|
Plasma Concentration of Inorganic Pyrophosphate (PPi)
Day 36
|
1.417 micromole/Liter (umol/L)
Standard Deviation 0.1845
|
1.455 micromole/Liter (umol/L)
Standard Deviation 0.2036
|
1.412 micromole/Liter (umol/L)
Standard Deviation 0.2226
|
1.516 micromole/Liter (umol/L)
Standard Deviation 0.2192
|
1.308 micromole/Liter (umol/L)
Standard Deviation 0.1760
|
1.180 micromole/Liter (umol/L)
Standard Deviation 0.2347
|
1.413 micromole/Liter (umol/L)
Standard Deviation 0.2283
|
|
Plasma Concentration of Inorganic Pyrophosphate (PPi)
Day 43
|
1.433 micromole/Liter (umol/L)
Standard Deviation 0.2263
|
1.418 micromole/Liter (umol/L)
Standard Deviation 0.2204
|
1.553 micromole/Liter (umol/L)
Standard Deviation 0.3434
|
1.615 micromole/Liter (umol/L)
Standard Deviation 0.1463
|
1.377 micromole/Liter (umol/L)
Standard Deviation 0.2673
|
1.243 micromole/Liter (umol/L)
Standard Deviation 0.3406
|
1.225 micromole/Liter (umol/L)
Standard Deviation 0.1939
|
|
Plasma Concentration of Inorganic Pyrophosphate (PPi)
Day 75
|
1.496 micromole/Liter (umol/L)
Standard Deviation 0.1576
|
1.375 micromole/Liter (umol/L)
Standard Deviation 0.2001
|
1.592 micromole/Liter (umol/L)
Standard Deviation 0.3540
|
1.820 micromole/Liter (umol/L)
Standard Deviation 0.0424
|
1.495 micromole/Liter (umol/L)
Standard Deviation 0.2073
|
1.527 micromole/Liter (umol/L)
Standard Deviation 0.2527
|
1.290 micromole/Liter (umol/L)
Standard Deviation 0.1968
|
SECONDARY outcome
Timeframe: Day 1 (predose), 2, 3, 5, 8, 15, 22, 29, 36, 43, and 75Population: All treated participants for whom the PD profile of ALXN1910 can be adequately characterized were included in the PD Set. Here, Number Analyzed refers to the number of participants available for the specific Outcome measure for specific timeframe.
The plasma concentrations of PL was assessed.
Outcome measures
| Measure |
Cohort 1- 5 mg
n=6 Participants
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=6 Participants
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
n=6 Participants
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
n=6 Participants
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
n=6 Participants
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
n=6 Participants
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
n=12 Participants
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
Plasma Concentration of Pyridoxal (PL)
Day 75
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0.0700
|
4.033 nanogram/milliliter (ng/ml)
Standard Deviation 4.9806
|
3.305 nanogram/milliliter (ng/ml)
Standard Deviation 1.8455
|
2.498 nanogram/milliliter (ng/ml)
Standard Deviation 0.9561
|
2.580 nanogram/milliliter (ng/ml)
Standard Deviation 0.7991
|
2.525 nanogram/milliliter (ng/ml)
Standard Deviation 1.6742
|
|
Plasma Concentration of Pyridoxal (PL)
Day 1
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
2.133 nanogram/milliliter (ng/ml)
Standard Deviation 0.3266
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
2.092 nanogram/milliliter (ng/ml)
Standard Deviation 0.2245
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
2.182 nanogram/milliliter (ng/ml)
Standard Deviation 0.3561
|
2.003 nanogram/milliliter (ng/ml)
Standard Deviation 0.0087
|
|
Plasma Concentration of Pyridoxal (PL)
Day 2
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
2.078 nanogram/milliliter (ng/ml)
Standard Deviation 0.1919
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
2.395 nanogram/milliliter (ng/ml)
Standard Deviation 0.6874
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
|
Plasma Concentration of Pyridoxal (PL)
Day 3
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
2.088 nanogram/milliliter (ng/ml)
Standard Deviation 0.1412
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
2.280 nanogram/milliliter (ng/ml)
Standard Deviation 0.5295
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
|
Plasma Concentration of Pyridoxal (PL)
Day 5
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
2.015 nanogram/milliliter (ng/ml)
Standard Deviation 0.0367
|
2.157 nanogram/milliliter (ng/ml)
Standard Deviation 0.3552
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
|
Plasma Concentration of Pyridoxal (PL)
Day 8
|
2.035 nanogram/milliliter (ng/ml)
Standard Deviation 0.0857
|
2.025 nanogram/milliliter (ng/ml)
Standard Deviation 0.0612
|
2.135 nanogram/milliliter (ng/ml)
Standard Deviation 0.3307
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
3.903 nanogram/milliliter (ng/ml)
Standard Deviation 4.6037
|
2.028 nanogram/milliliter (ng/ml)
Standard Deviation 0.0626
|
2.014 nanogram/milliliter (ng/ml)
Standard Deviation 0.0491
|
|
Plasma Concentration of Pyridoxal (PL)
Day 15
|
2.108 nanogram/milliliter (ng/ml)
Standard Deviation 0.1855
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
2.850 nanogram/milliliter (ng/ml)
Standard Deviation 1.6067
|
3.877 nanogram/milliliter (ng/ml)
Standard Deviation 4.1356
|
3.430 nanogram/milliliter (ng/ml)
Standard Deviation 2.7195
|
2.183 nanogram/milliliter (ng/ml)
Standard Deviation 0.6319
|
|
Plasma Concentration of Pyridoxal (PL)
Day 22
|
6.230 nanogram/milliliter (ng/ml)
Standard Deviation 8.9909
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
2.017 nanogram/milliliter (ng/ml)
Standard Deviation 0.0408
|
5.042 nanogram/milliliter (ng/ml)
Standard Deviation 5.0662
|
2.140 nanogram/milliliter (ng/ml)
Standard Deviation 0.2706
|
2.725 nanogram/milliliter (ng/ml)
Standard Deviation 1.6564
|
3.904 nanogram/milliliter (ng/ml)
Standard Deviation 4.9090
|
|
Plasma Concentration of Pyridoxal (PL)
Day 29
|
2.012 nanogram/milliliter (ng/ml)
Standard Deviation 0.0286
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
3.524 nanogram/milliliter (ng/ml)
Standard Deviation 2.8236
|
2.652 nanogram/milliliter (ng/ml)
Standard Deviation 1.4579
|
2.366 nanogram/milliliter (ng/ml)
Standard Deviation 0.7119
|
3.922 nanogram/milliliter (ng/ml)
Standard Deviation 4.4773
|
|
Plasma Concentration of Pyridoxal (PL)
Day 36
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
3.783 nanogram/milliliter (ng/ml)
Standard Deviation 3.5650
|
2.732 nanogram/milliliter (ng/ml)
Standard Deviation 1.5382
|
2.303 nanogram/milliliter (ng/ml)
Standard Deviation 0.3774
|
3.264 nanogram/milliliter (ng/ml)
Standard Deviation 4.1910
|
|
Plasma Concentration of Pyridoxal (PL)
Day 43
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
2.000 nanogram/milliliter (ng/ml)
Standard Deviation 0
|
4.368 nanogram/milliliter (ng/ml)
Standard Deviation 4.8417
|
2.797 nanogram/milliliter (ng/ml)
Standard Deviation 1.9368
|
2.052 nanogram/milliliter (ng/ml)
Standard Deviation 0.0816
|
2.119 nanogram/milliliter (ng/ml)
Standard Deviation 0.2683
|
SECONDARY outcome
Timeframe: Day 1 (predose), 2, 3, 5, 8, 15, 22, 29, 36, 43, and 75Population: All treated participants for whom the PD profile of ALXN1910 can be adequately characterized were included in the PD Set. Here, Number Analyzed refers to the number of participants available for the specific Outcome measure for specific timeframe.
The plasma concentrations of PLP was assessed.
Outcome measures
| Measure |
Cohort 1- 5 mg
n=6 Participants
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=6 Participants
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
n=6 Participants
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
n=6 Participants
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
n=6 Participants
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
n=6 Participants
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
n=12 Participants
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
Plasma Concentration of Pyridoxal 5-Phosphate (PLP)
Day 1
|
10.187 nanogram/milliliter (ng/ml)
Standard Deviation 4.6534
|
10.332 nanogram/milliliter (ng/ml)
Standard Deviation 3.5662
|
9.817 nanogram/milliliter (ng/ml)
Standard Deviation 4.8904
|
15.883 nanogram/milliliter (ng/ml)
Standard Deviation 5.7614
|
11.503 nanogram/milliliter (ng/ml)
Standard Deviation 6.2856
|
13.940 nanogram/milliliter (ng/ml)
Standard Deviation 4.5167
|
8.789 nanogram/milliliter (ng/ml)
Standard Deviation 3.8742
|
|
Plasma Concentration of Pyridoxal 5-Phosphate (PLP)
Day 2
|
7.593 nanogram/milliliter (ng/ml)
Standard Deviation 2.3404
|
9.150 nanogram/milliliter (ng/ml)
Standard Deviation 3.5081
|
6.532 nanogram/milliliter (ng/ml)
Standard Deviation 2.5528
|
11.777 nanogram/milliliter (ng/ml)
Standard Deviation 4.2860
|
10.552 nanogram/milliliter (ng/ml)
Standard Deviation 5.1884
|
6.508 nanogram/milliliter (ng/ml)
Standard Deviation 1.6985
|
8.356 nanogram/milliliter (ng/ml)
Standard Deviation 3.8675
|
|
Plasma Concentration of Pyridoxal 5-Phosphate (PLP)
Day 3
|
8.148 nanogram/milliliter (ng/ml)
Standard Deviation 2.2653
|
9.398 nanogram/milliliter (ng/ml)
Standard Deviation 3.3232
|
7.110 nanogram/milliliter (ng/ml)
Standard Deviation 2.4781
|
11.487 nanogram/milliliter (ng/ml)
Standard Deviation 4.1591
|
8.182 nanogram/milliliter (ng/ml)
Standard Deviation 3.6379
|
5.737 nanogram/milliliter (ng/ml)
Standard Deviation 1.1692
|
8.753 nanogram/milliliter (ng/ml)
Standard Deviation 4.0128
|
|
Plasma Concentration of Pyridoxal 5-Phosphate (PLP)
Day 5
|
8.597 nanogram/milliliter (ng/ml)
Standard Deviation 3.5325
|
9.158 nanogram/milliliter (ng/ml)
Standard Deviation 3.4736
|
7.038 nanogram/milliliter (ng/ml)
Standard Deviation 2.0301
|
10.098 nanogram/milliliter (ng/ml)
Standard Deviation 1.6344
|
7.672 nanogram/milliliter (ng/ml)
Standard Deviation 3.2028
|
5.490 nanogram/milliliter (ng/ml)
Standard Deviation 1.2002
|
8.942 nanogram/milliliter (ng/ml)
Standard Deviation 5.0870
|
|
Plasma Concentration of Pyridoxal 5-Phosphate (PLP)
Day 8
|
8.753 nanogram/milliliter (ng/ml)
Standard Deviation 3.4828
|
9.443 nanogram/milliliter (ng/ml)
Standard Deviation 2.9710
|
8.190 nanogram/milliliter (ng/ml)
Standard Deviation 5.6565
|
10.572 nanogram/milliliter (ng/ml)
Standard Deviation 3.8381
|
7.562 nanogram/milliliter (ng/ml)
Standard Deviation 2.7438
|
5.270 nanogram/milliliter (ng/ml)
Standard Deviation 0.6037
|
8.960 nanogram/milliliter (ng/ml)
Standard Deviation 4.4173
|
|
Plasma Concentration of Pyridoxal 5-Phosphate (PLP)
Day 15
|
10.170 nanogram/milliliter (ng/ml)
Standard Deviation 5.1691
|
8.360 nanogram/milliliter (ng/ml)
Standard Deviation 2.5086
|
8.800 nanogram/milliliter (ng/ml)
Standard Deviation 5.7621
|
18.927 nanogram/milliliter (ng/ml)
Standard Deviation 11.9441
|
9.292 nanogram/milliliter (ng/ml)
Standard Deviation 4.7827
|
10.040 nanogram/milliliter (ng/ml)
Standard Deviation 5.4156
|
10.328 nanogram/milliliter (ng/ml)
Standard Deviation 7.0041
|
|
Plasma Concentration of Pyridoxal 5-Phosphate (PLP)
Day 22
|
13.656 nanogram/milliliter (ng/ml)
Standard Deviation 14.9897
|
8.384 nanogram/milliliter (ng/ml)
Standard Deviation 2.6076
|
9.805 nanogram/milliliter (ng/ml)
Standard Deviation 7.1460
|
30.427 nanogram/milliliter (ng/ml)
Standard Deviation 22.5240
|
10.828 nanogram/milliliter (ng/ml)
Standard Deviation 4.5559
|
10.380 nanogram/milliliter (ng/ml)
Standard Deviation 8.4672
|
20.086 nanogram/milliliter (ng/ml)
Standard Deviation 26.9065
|
|
Plasma Concentration of Pyridoxal 5-Phosphate (PLP)
Day 29
|
9.722 nanogram/milliliter (ng/ml)
Standard Deviation 2.8996
|
8.758 nanogram/milliliter (ng/ml)
Standard Deviation 4.4855
|
8.610 nanogram/milliliter (ng/ml)
Standard Deviation 2.6303
|
26.354 nanogram/milliliter (ng/ml)
Standard Deviation 24.3632
|
14.880 nanogram/milliliter (ng/ml)
Standard Deviation 10.5484
|
12.682 nanogram/milliliter (ng/ml)
Standard Deviation 7.7458
|
16.309 nanogram/milliliter (ng/ml)
Standard Deviation 21.8318
|
|
Plasma Concentration of Pyridoxal 5-Phosphate (PLP)
Day 36
|
11.115 nanogram/milliliter (ng/ml)
Standard Deviation 4.5799
|
7.932 nanogram/milliliter (ng/ml)
Standard Deviation 2.6500
|
8.118 nanogram/milliliter (ng/ml)
Standard Deviation 3.6145
|
19.608 nanogram/milliliter (ng/ml)
Standard Deviation 19.6025
|
18.514 nanogram/milliliter (ng/ml)
Standard Deviation 12.7452
|
12.318 nanogram/milliliter (ng/ml)
Standard Deviation 3.4330
|
14.191 nanogram/milliliter (ng/ml)
Standard Deviation 15.8284
|
|
Plasma Concentration of Pyridoxal 5-Phosphate (PLP)
Day 43
|
10.597 nanogram/milliliter (ng/ml)
Standard Deviation 4.7562
|
8.697 nanogram/milliliter (ng/ml)
Standard Deviation 3.6949
|
8.577 nanogram/milliliter (ng/ml)
Standard Deviation 3.3439
|
22.367 nanogram/milliliter (ng/ml)
Standard Deviation 19.3420
|
16.223 nanogram/milliliter (ng/ml)
Standard Deviation 14.2766
|
9.033 nanogram/milliliter (ng/ml)
Standard Deviation 2.5026
|
10.026 nanogram/milliliter (ng/ml)
Standard Deviation 5.6783
|
|
Plasma Concentration of Pyridoxal 5-Phosphate (PLP)
Day 75
|
12.284 nanogram/milliliter (ng/ml)
Standard Deviation 4.3254
|
9.620 nanogram/milliliter (ng/ml)
Standard Deviation 5.6757
|
10.010 nanogram/milliliter (ng/ml)
Standard Deviation 4.9121
|
17.750 nanogram/milliliter (ng/ml)
Standard Deviation 18.0312
|
14.918 nanogram/milliliter (ng/ml)
Standard Deviation 8.7744
|
15.292 nanogram/milliliter (ng/ml)
Standard Deviation 6.7615
|
13.228 nanogram/milliliter (ng/ml)
Standard Deviation 13.3117
|
SECONDARY outcome
Timeframe: Day 1 (predose), 2, 3, 5, 8, 15, 22, 29, 36, 43, and 75Population: All treated participants for whom the PD profile of ALXN1910 can be adequately characterized were included in the PD Set. Here, Number Analyzed refers to the number of participants available for the specific Outcome measure for specific timeframe.
The plasma concentrations of PA was assessed.
Outcome measures
| Measure |
Cohort 1- 5 mg
n=6 Participants
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=6 Participants
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
n=6 Participants
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
n=6 Participants
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
n=6 Participants
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
n=6 Participants
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
n=12 Participants
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
Plasma Concentration of Pyridoxic Acid (PA)
Day 29
|
3.453 nanogram/milliliter (ng/ml)
Standard Deviation 1.0153
|
2.575 nanogram/milliliter (ng/ml)
Standard Deviation 0.6291
|
3.070 nanogram/milliliter (ng/ml)
Standard Deviation 1.0623
|
6.922 nanogram/milliliter (ng/ml)
Standard Deviation 7.2945
|
4.576 nanogram/milliliter (ng/ml)
Standard Deviation 3.4900
|
4.482 nanogram/milliliter (ng/ml)
Standard Deviation 2.3754
|
4.553 nanogram/milliliter (ng/ml)
Standard Deviation 4.6084
|
|
Plasma Concentration of Pyridoxic Acid (PA)
Day 36
|
2.833 nanogram/milliliter (ng/ml)
Standard Deviation 1.1429
|
2.657 nanogram/milliliter (ng/ml)
Standard Deviation 0.7266
|
2.563 nanogram/milliliter (ng/ml)
Standard Deviation 1.1121
|
6.185 nanogram/milliliter (ng/ml)
Standard Deviation 7.3577
|
4.236 nanogram/milliliter (ng/ml)
Standard Deviation 2.7877
|
3.950 nanogram/milliliter (ng/ml)
Standard Deviation 1.6757
|
4.557 nanogram/milliliter (ng/ml)
Standard Deviation 4.8259
|
|
Plasma Concentration of Pyridoxic Acid (PA)
Day 43
|
2.415 nanogram/milliliter (ng/ml)
Standard Deviation 0.5445
|
2.827 nanogram/milliliter (ng/ml)
Standard Deviation 0.8977
|
3.330 nanogram/milliliter (ng/ml)
Standard Deviation 1.9655
|
8.055 nanogram/milliliter (ng/ml)
Standard Deviation 8.7461
|
4.123 nanogram/milliliter (ng/ml)
Standard Deviation 3.3854
|
3.220 nanogram/milliliter (ng/ml)
Standard Deviation 0.8897
|
3.328 nanogram/milliliter (ng/ml)
Standard Deviation 1.4716
|
|
Plasma Concentration of Pyridoxic Acid (PA)
Day 75
|
3.620 nanogram/milliliter (ng/ml)
Standard Deviation 1.2921
|
2.998 nanogram/milliliter (ng/ml)
Standard Deviation 0.9216
|
2.868 nanogram/milliliter (ng/ml)
Standard Deviation 0.7116
|
6.350 nanogram/milliliter (ng/ml)
Standard Deviation 6.1518
|
3.595 nanogram/milliliter (ng/ml)
Standard Deviation 1.8915
|
4.580 nanogram/milliliter (ng/ml)
Standard Deviation 1.1087
|
3.695 nanogram/milliliter (ng/ml)
Standard Deviation 2.7428
|
|
Plasma Concentration of Pyridoxic Acid (PA)
Day 1
|
2.613 nanogram/milliliter (ng/ml)
Standard Deviation 0.8986
|
3.088 nanogram/milliliter (ng/ml)
Standard Deviation 0.5566
|
2.988 nanogram/milliliter (ng/ml)
Standard Deviation 1.0540
|
3.590 nanogram/milliliter (ng/ml)
Standard Deviation 1.8724
|
2.750 nanogram/milliliter (ng/ml)
Standard Deviation 0.8456
|
3.797 nanogram/milliliter (ng/ml)
Standard Deviation 1.3833
|
2.798 nanogram/milliliter (ng/ml)
Standard Deviation 0.7626
|
|
Plasma Concentration of Pyridoxic Acid (PA)
Day 2
|
2.270 nanogram/milliliter (ng/ml)
Standard Deviation 0.5563
|
2.502 nanogram/milliliter (ng/ml)
Standard Deviation 0.3333
|
2.580 nanogram/milliliter (ng/ml)
Standard Deviation 0.6935
|
3.140 nanogram/milliliter (ng/ml)
Standard Deviation 1.4506
|
2.680 nanogram/milliliter (ng/ml)
Standard Deviation 0.7706
|
2.955 nanogram/milliliter (ng/ml)
Standard Deviation 0.9038
|
2.541 nanogram/milliliter (ng/ml)
Standard Deviation 0.5817
|
|
Plasma Concentration of Pyridoxic Acid (PA)
Day 3
|
2.273 nanogram/milliliter (ng/ml)
Standard Deviation 0.3469
|
2.828 nanogram/milliliter (ng/ml)
Standard Deviation 0.5980
|
2.558 nanogram/milliliter (ng/ml)
Standard Deviation 0.6787
|
3.240 nanogram/milliliter (ng/ml)
Standard Deviation 1.1469
|
2.463 nanogram/milliliter (ng/ml)
Standard Deviation 0.5376
|
2.828 nanogram/milliliter (ng/ml)
Standard Deviation 0.8422
|
2.751 nanogram/milliliter (ng/ml)
Standard Deviation 0.6523
|
|
Plasma Concentration of Pyridoxic Acid (PA)
Day 5
|
2.517 nanogram/milliliter (ng/ml)
Standard Deviation 0.4942
|
2.782 nanogram/milliliter (ng/ml)
Standard Deviation 0.5094
|
2.702 nanogram/milliliter (ng/ml)
Standard Deviation 0.5883
|
3.070 nanogram/milliliter (ng/ml)
Standard Deviation 0.9821
|
2.605 nanogram/milliliter (ng/ml)
Standard Deviation 0.5392
|
3.125 nanogram/milliliter (ng/ml)
Standard Deviation 0.3094
|
2.713 nanogram/milliliter (ng/ml)
Standard Deviation 0.5881
|
|
Plasma Concentration of Pyridoxic Acid (PA)
Day 8
|
2.680 nanogram/milliliter (ng/ml)
Standard Deviation 1.5016
|
2.797 nanogram/milliliter (ng/ml)
Standard Deviation 1.0017
|
2.733 nanogram/milliliter (ng/ml)
Standard Deviation 0.8122
|
3.497 nanogram/milliliter (ng/ml)
Standard Deviation 1.6013
|
3.012 nanogram/milliliter (ng/ml)
Standard Deviation 1.1908
|
3.054 nanogram/milliliter (ng/ml)
Standard Deviation 0.4078
|
2.939 nanogram/milliliter (ng/ml)
Standard Deviation 0.8534
|
|
Plasma Concentration of Pyridoxic Acid (PA)
Day 15
|
2.812 nanogram/milliliter (ng/ml)
Standard Deviation 0.9420
|
3.000 nanogram/milliliter (ng/ml)
Standard Deviation 1.0794
|
2.908 nanogram/milliliter (ng/ml)
Standard Deviation 0.9542
|
5.132 nanogram/milliliter (ng/ml)
Standard Deviation 3.4143
|
3.285 nanogram/milliliter (ng/ml)
Standard Deviation 1.7404
|
6.118 nanogram/milliliter (ng/ml)
Standard Deviation 5.5760
|
2.930 nanogram/milliliter (ng/ml)
Standard Deviation 1.4804
|
|
Plasma Concentration of Pyridoxic Acid (PA)
Day 22
|
10.750 nanogram/milliliter (ng/ml)
Standard Deviation 18.8695
|
2.566 nanogram/milliliter (ng/ml)
Standard Deviation 0.6971
|
3.172 nanogram/milliliter (ng/ml)
Standard Deviation 1.8925
|
10.143 nanogram/milliliter (ng/ml)
Standard Deviation 11.4645
|
3.946 nanogram/milliliter (ng/ml)
Standard Deviation 1.9630
|
4.532 nanogram/milliliter (ng/ml)
Standard Deviation 2.0736
|
5.579 nanogram/milliliter (ng/ml)
Standard Deviation 7.2517
|
SECONDARY outcome
Timeframe: Day 1 (postdose) through Day 75Population: All randomized/enrolled participants who received at least 1 dose of the study intervention and who after the dose have at least 1 reportable ADA result. Participants were analyzed according to the study intervention they actually received.
The ADAs of ALXN1910 was assessed as immunogenicity parameter. Treatment-emergent ADA Responses is defined as a positive result in the ADA assay post first dose, when baseline results are negative or missing.
Outcome measures
| Measure |
Cohort 1- 5 mg
n=6 Participants
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=6 Participants
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
n=6 Participants
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
n=6 Participants
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
n=6 Participants
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
n=6 Participants
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
n=12 Participants
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Treatment-Emergent Antidrug Antibodies (ADAs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 75Population: All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received. Here, Number Analyzed refers to the number of participants available for the specific Outcome measure analysis.
The absolute bioavailability GMR AUC∞ of ALXN1910 SC was assessed.
Outcome measures
| Measure |
Cohort 1- 5 mg
n=3 Participants
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=6 Participants
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratio (GMR) of Area Under the Curve (AUC∞) Values of Subcutaneous (SC) Versus Intravenous (IV) Serum Concentration of ALXN1910
|
168.05 h × μg/mL
Interval 135.38 to 208.59
|
244.51 h × μg/mL
Interval 209.85 to 284.88
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 75Population: All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received.
Quantitative assessment of PK parameter (Cmax) was assessed between Japanese and non-Japanese participants.
Outcome measures
| Measure |
Cohort 1- 5 mg
n=6 Participants
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=6 Participants
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) in Japanese and Non-Japanese Participants
|
0.32 μg/mL
Interval 0.21 to 0.48
|
0.38 μg/mL
Interval 0.25 to 0.57
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 75Population: All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received.
Quantitative assessment of PK parameter (AUCt) was assessed between Japanese and non-Japanese participants.
Outcome measures
| Measure |
Cohort 1- 5 mg
n=6 Participants
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=6 Participants
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
AUC From Time Zero to the Last Quantifiable Concentration (AUCt) in Japanese and Non-Japanese Participants
|
102.37 h × μg/mL
Interval 73.49 to 142.61
|
120.94 h × μg/mL
Interval 86.82 to 168.48
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 75Population: All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received. Here, Number Analyzed refers to the number of participants available for the specific Outcome measure analysis.
Quantitative assessment of PK parameter (AUC∞) was assessed between Japanese and non-Japanese participants.
Outcome measures
| Measure |
Cohort 1- 5 mg
n=3 Participants
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=5 Participants
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
AUC From Time Zero Extrapolated to Infinity (AUC∞) in Japanese and Non-Japanese Participants
|
168.05 h × μg/mL
Interval 122.84 to 229.89
|
157.78 h × μg/mL
Interval 123.78 to 201.12
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 2, 15, 22, 43, and 75Population: All treated participants for whom the PD profile of ALXN1910 can be adequately characterized were included in the PD Set.
Change from baseline in PD parameter Inorganic Pyrophosphate was evaluated over time for Japanese and non-Japanese participants (Cohort 2 versus Cohort 4) on active treatment.
Outcome measures
| Measure |
Cohort 1- 5 mg
n=6 Participants
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=6 Participants
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Inorganic Pyrophosphate Concentration in Japanese and Non-Japanese Participants
Day 2
|
-0.195 μmol
Standard Error 0.101
|
-0.152 μmol
Standard Error 0.101
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Inorganic Pyrophosphate Concentration in Japanese and Non-Japanese Participants
Day 15
|
-0.357 μmol
Standard Error 0.101
|
-0.251 μmol
Standard Error 0.101
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Inorganic Pyrophosphate Concentration in Japanese and Non-Japanese Participants
Day 22
|
-0.355 μmol
Standard Error 0.106
|
-0.176 μmol
Standard Error 0.101
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Inorganic Pyrophosphate Concentration in Japanese and Non-Japanese Participants
Day 43
|
-0.327 μmol
Standard Error 0.101
|
-0.119 μmol
Standard Error 0.101
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Inorganic Pyrophosphate Concentration in Japanese and Non-Japanese Participants
Day 75
|
-0.329 μmol
Standard Error 0.114
|
-0.015 μmol
Standard Error 0.147
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 2, 15, 22, 43, and 75Population: All treated participants for whom the PD profile of ALXN1910 can be adequately characterized were included in the PD Set.
Change from baseline in PD parameter Pyridoxal-5-phosphate was evaluated over time for Japanese and non-Japanese participants (Cohort 2 versus Cohort 4) on active treatment
Outcome measures
| Measure |
Cohort 1- 5 mg
n=6 Participants
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=6 Participants
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Pyridoxal-5-phosphate Concentration in Japanese and Non-Japanese Participants
Day 2
|
-0.430 μmol
Standard Error 3.628
|
-4.957 μmol
Standard Error 3.659
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Pyridoxal-5-phosphate Concentration in Japanese and Non-Japanese Participants
Day 15
|
-1.220 μmol
Standard Error 3.628
|
2.193 μmol
Standard Error 3.659
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Pyridoxal-5-phosphate Concentration in Japanese and Non-Japanese Participants
Day 22
|
-0.412 μmol
Standard Error 3.900
|
13.693 μmol
Standard Error 3.659
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Pyridoxal-5-phosphate Concentration in Japanese and Non-Japanese Participants
Day 43
|
-0.883 μmol
Standard Error 3.628
|
5.633 μmol
Standard Error 3.659
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Pyridoxal-5-phosphate Concentration in Japanese and Non-Japanese Participants
Day 75
|
1.137 μmol
Standard Error 4.269
|
2.839 μmol
Standard Error 5.677
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 2, 15, 22, 43, and 75Population: All treated participants for whom the PD profile of ALXN1910 can be adequately characterized were included in the PD Set.
Change from baseline in PD parameter Pyridoxal was evaluated over time for Japanese and non-Japanese participants (Cohort 2 versus Cohort 4) on active treatment.
Outcome measures
| Measure |
Cohort 1- 5 mg
n=6 Participants
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=6 Participants
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Pyridoxal Concentration in Japanese and Non-Japanese Participants
Day 2
|
-0.093 ng/mL
Standard Error 0.740
|
-0.061 ng/mL
Standard Error 0.740
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Pyridoxal Concentration in Japanese and Non-Japanese Participants
Day 15
|
-0.171 ng/mL
Standard Error 0.740
|
0.789 ng/mL
Standard Error 0.740
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Pyridoxal Concentration in Japanese and Non-Japanese Participants
Day 22
|
0.190 ng/mL
Standard Error 0.795
|
2.981 ng/mL
Standard Error 0.740
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Pyridoxal Concentration in Japanese and Non-Japanese Participants
Day 43
|
-0.171 ng/mL
Standard Error 0.740
|
2.308 ng/mL
Standard Error 0.740
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Pyridoxal Concentration in Japanese and Non-Japanese Participants
Day 75
|
-0.063 ng/mL
Standard Error 0.868
|
1.789 ng/mL
Standard Error 1.174
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 2, 15, 22, 43, and 75Population: All treated participants for whom the PD profile of ALXN1910 can be adequately characterized were included in the PD Set.
Change from baseline in PD parameter Pyridoxic Acid was evaluated over time for Japanese and non-Japanese participants (Cohort 2 versus Cohort 4) on active treatment.
Outcome measures
| Measure |
Cohort 1- 5 mg
n=6 Participants
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=6 Participants
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Pyridoxic Acid Concentration in Japanese and Non-Japanese Participants
Day 2
|
-0.316 ng/mL
Standard Error 1.263
|
-0.725 ng/mL
Standard Error 1.263
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Pyridoxic Acid Concentration in Japanese and Non-Japanese Participants
Day 15
|
0.182 ng/mL
Standard Error 1.263
|
1.267 ng/mL
Standard Error 1.263
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Pyridoxic Acid Concentration in Japanese and Non-Japanese Participants
Day 22
|
-0.238 ng/mL
Standard Error 1.383
|
6.278 ng/mL
Standard Error 1.263
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Pyridoxic Acid Concentration in Japanese and Non-Japanese Participants
Day 43
|
0.009 ng/mL
Standard Error 1.263
|
4.190 ng/mL
Standard Error 1.263
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Pyridoxic Acid Concentration in Japanese and Non-Japanese Participants
Day 75
|
0.189 ng/mL
Standard Error 1.545
|
4.812 ng/mL
Standard Error 2.184
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1- 5 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2- 15 mg SC
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3- 15 mg IV
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Japanese Cohort 4- 15 mg SC
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 5- 45 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 6- 135 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Pooled Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1- 5 mg
n=6 participants at risk
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=6 participants at risk
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
n=6 participants at risk
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
n=6 participants at risk
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
n=6 participants at risk
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
n=6 participants at risk
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
n=12 participants at risk
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
Other adverse events
| Measure |
Cohort 1- 5 mg
n=6 participants at risk
Participants received a single dose of 5 mg of ALXN1910 IV.
|
Cohort 2- 15 mg SC
n=6 participants at risk
Participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 3- 15 mg IV
n=6 participants at risk
Participant received a single dose of 15 mg of ALXN1910 IV.
|
Japanese Cohort 4- 15 mg SC
n=6 participants at risk
Japanese participants received a single dose of 15 mg of ALXN1910 SC.
|
Cohort 5- 45 mg
n=6 participants at risk
Participants received a single dose of 45 mg of ALXN1910 SC.
|
Cohort 6- 135 mg
n=6 participants at risk
Participants received a single dose of 135 mg of ALXN1910 SC.
|
Pooled Placebo
n=12 participants at risk
Participants received a single dose of matching Placebo IV or SC.
|
|---|---|---|---|---|---|---|---|
|
General disorders
Catheter site bruise
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
8.3%
1/12 • Number of events 1 • Day 1 (postdose) through Day 75
|
|
General disorders
Fatigue
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
8.3%
1/12 • Number of events 1 • Day 1 (postdose) through Day 75
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
General disorders
Catheter site related reaction
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
General disorders
Injection site erythema
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
General disorders
Injection site pruritus
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Infections and infestations
COVID-19
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
33.3%
2/6 • Number of events 2 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
8.3%
1/12 • Number of events 1 • Day 1 (postdose) through Day 75
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
8.3%
1/12 • Number of events 1 • Day 1 (postdose) through Day 75
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Infections and infestations
Infected bite
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
8.3%
1/12 • Number of events 1 • Day 1 (postdose) through Day 75
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 2 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
33.3%
2/6 • Number of events 2 • Day 1 (postdose) through Day 75
|
25.0%
3/12 • Number of events 4 • Day 1 (postdose) through Day 75
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
8.3%
1/12 • Number of events 1 • Day 1 (postdose) through Day 75
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
8.3%
1/12 • Number of events 1 • Day 1 (postdose) through Day 75
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
8.3%
1/12 • Number of events 1 • Day 1 (postdose) through Day 75
|
|
Gastrointestinal disorders
Dental discomfort
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 2 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Musculoskeletal and connective tissue disorders
Joint noise
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
2/12 • Number of events 2 • Day 1 (postdose) through Day 75
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 2 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
8.3%
1/12 • Number of events 1 • Day 1 (postdose) through Day 75
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
8.3%
1/12 • Number of events 1 • Day 1 (postdose) through Day 75
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Injury, poisoning and procedural complications
Muscle strain
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Reproductive system and breast disorders
Dysuria
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Renal and urinary disorders
Urethral discharge
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Renal and urinary disorders
Dysmenorrhoea
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 1 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
0.00%
0/6 • Day 1 (postdose) through Day 75
|
16.7%
1/6 • Number of events 2 • Day 1 (postdose) through Day 75
|
0.00%
0/12 • Day 1 (postdose) through Day 75
|
Additional Information
Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
Phone: +1 855-752-2356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER