Trial Outcomes & Findings for A Study of Single and Multiple SC Doses of ALXN1830 in Healthy Adult Participants (NCT NCT05254613)
NCT ID: NCT05254613
Last Updated: 2024-03-22
Results Overview
A TEAE was defined as any adverse event (AE) that commences after the start of administration of study drug. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An AE was considered serious if, in the view of the investigator or sponsor, it resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. A summary of all serious AEs and other AEs (nonserious) regardless of causality is located in 'Adverse events' Section.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Baseline up to Day 64
Results posted on
2024-03-22
Participant Flow
Due to a lack of participant availability caused by the COVID-19 pandemic, the study was terminated on 22 January 2021 after completion of the ALXN1830 subcutaneous 750 milligrams (mg) dose or placebo groups and partial enrollment of the ALXN1830 subcutaneous 1250 mg dose or placebo groups.
Participant milestones
| Measure |
ALXN1830 750 mg
Participants received a single dose of ALXN1830 750 mg subcutaneously on Day 1.
|
ALXN1830 1250 mg
Participants received a single dose of ALXN1830 1250 mg subcutaneously on Day 1.
|
Placebo
Participants received placebo matched to ALXN1830 subcutaneously on Day 1.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
3
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
6
|
3
|
3
|
|
Overall Study
COMPLETED
|
6
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
ALXN1830 750 mg
Participants received a single dose of ALXN1830 750 mg subcutaneously on Day 1.
|
ALXN1830 1250 mg
Participants received a single dose of ALXN1830 1250 mg subcutaneously on Day 1.
|
Placebo
Participants received placebo matched to ALXN1830 subcutaneously on Day 1.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Single and Multiple SC Doses of ALXN1830 in Healthy Adult Participants
Baseline characteristics by cohort
| Measure |
ALXN1830 750 mg
n=6 Participants
Participants received a single dose of ALXN1830 750 mg subcutaneously on Day 1.
|
ALXN1830 1250 mg
n=3 Participants
Participants received a single dose of ALXN1830 1250 mg subcutaneously on Day 1.
|
Placebo
n=3 Participants
Participants received placebo matched to ALXN1830 subcutaneously on Day 1.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
22.8 years
STANDARD_DEVIATION 2.93 • n=5 Participants
|
23.0 years
STANDARD_DEVIATION 3.46 • n=7 Participants
|
28.3 years
STANDARD_DEVIATION 5.86 • n=5 Participants
|
24.3 years
STANDARD_DEVIATION 4.29 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Chinese
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Other Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not of Hispanic, Latino/a, or Spanish Origin
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Another Hispanic, Latino/a, or Spanish Origin
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 64Population: The safety population consisted of all participants who received at least 1 dose of study drug.
A TEAE was defined as any adverse event (AE) that commences after the start of administration of study drug. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An AE was considered serious if, in the view of the investigator or sponsor, it resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. A summary of all serious AEs and other AEs (nonserious) regardless of causality is located in 'Adverse events' Section.
Outcome measures
| Measure |
ALXN1830 750 mg
n=6 Participants
Participants received a single dose of ALXN1830 750 mg subcutaneously on Day 1.
|
ALXN1830 1250 mg
n=3 Participants
Participants received a single dose of ALXN1830 1250 mg subcutaneously on Day 1.
|
Placebo
n=3 Participants
Participants received placebo matched to ALXN1830 subcutaneously on Day 1.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
AEs
|
5 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose, end of infusion, and 0.5, 2, 4, 8, and 12 hours postdose on Day 1; and Days 2 to 8Population: The pharmacokinetic (PK) population consisted of all participants who had sufficient serum ALXN1830 concentration data to evaluate PK parameters. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Outcome measures
| Measure |
ALXN1830 750 mg
n=1 Participants
Participants received a single dose of ALXN1830 750 mg subcutaneously on Day 1.
|
ALXN1830 1250 mg
n=3 Participants
Participants received a single dose of ALXN1830 1250 mg subcutaneously on Day 1.
|
Placebo
Participants received placebo matched to ALXN1830 subcutaneously on Day 1.
|
|---|---|---|---|
|
Area Under The Serum Concentration Versus Time Curve From Time Zero (Dosing) To The Last Quantifiable Concentration (AUC0-t) of ALXN1830
|
31.8 hour*nanogram/milliliter
|
44.2 hour*nanogram/milliliter
Standard Deviation 33.7
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 10Population: The pharmacodynamic (PD) population consisted of all participants who had sufficient serum IgG data to evaluate pharmacodynamics effects.
Outcome measures
| Measure |
ALXN1830 750 mg
n=6 Participants
Participants received a single dose of ALXN1830 750 mg subcutaneously on Day 1.
|
ALXN1830 1250 mg
n=3 Participants
Participants received a single dose of ALXN1830 1250 mg subcutaneously on Day 1.
|
Placebo
n=3 Participants
Participants received placebo matched to ALXN1830 subcutaneously on Day 1.
|
|---|---|---|---|
|
Percent Change From Baseline in Immunoglobulin G (IgG) Levels at Day 10
|
-36.137 percent change
Standard Deviation 3.7163
|
-39.044 percent change
Standard Deviation 2.0933
|
-2.369 percent change
Standard Deviation 6.6831
|
SECONDARY outcome
Timeframe: Baseline up to Day 64Population: The immunogenicity population consisted of all participants who had ADA sample collected.
Outcome measures
| Measure |
ALXN1830 750 mg
n=6 Participants
Participants received a single dose of ALXN1830 750 mg subcutaneously on Day 1.
|
ALXN1830 1250 mg
n=3 Participants
Participants received a single dose of ALXN1830 1250 mg subcutaneously on Day 1.
|
Placebo
n=3 Participants
Participants received placebo matched to ALXN1830 subcutaneously on Day 1.
|
|---|---|---|---|
|
Number of Participants With Positive Anti-Drug Antibodies (ADA)
|
4 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 64Population: The immunogenicity population consisted of all participants who had ADA sample collected. Here, 'Overall number of participants analyzed' = participants with positive ADA.
All samples that are confirmed positive for ADA were evaluated for the presence of neutralizing antibodies.
Outcome measures
| Measure |
ALXN1830 750 mg
n=4 Participants
Participants received a single dose of ALXN1830 750 mg subcutaneously on Day 1.
|
ALXN1830 1250 mg
n=2 Participants
Participants received a single dose of ALXN1830 1250 mg subcutaneously on Day 1.
|
Placebo
Participants received placebo matched to ALXN1830 subcutaneously on Day 1.
|
|---|---|---|---|
|
Number of Participants With Positive Neutralizing Antibodies (NAbs)
|
2 Participants
|
2 Participants
|
—
|
Adverse Events
ALXN1830 750 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
ALXN1830 1250 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ALXN1830 750 mg
n=6 participants at risk
Participants received a single dose of ALXN1830 750 mg subcutaneously on Day 1.
|
ALXN1830 1250 mg
n=3 participants at risk
Participants received a single dose of ALXN1830 1250 mg subcutaneously on Day 1.
|
Placebo
n=3 participants at risk
Participants received placebo matched to ALXN1830 subcutaneously on Day 1.
|
|---|---|---|---|
|
Infections and infestations
Viral upper respiratory tract infection
|
83.3%
5/6 • Number of events 5 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
100.0%
3/3 • Number of events 3 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Number of events 3 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Number of events 1 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/6 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Number of events 3 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 2 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Number of events 2 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/6 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site discomfort
|
0.00%
0/6 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Number of events 2 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/6 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Baseline up to Day 64
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: +1 855-752-2356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place