Trial Outcomes & Findings for Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults (NCT NCT04840849)
NCT ID: NCT04840849
Last Updated: 2023-11-02
Results Overview
Serum samples were collected at indicated timepoints to determine the serum concentration of nirsevimab.
COMPLETED
PHASE1
24 participants
Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose.
2023-11-02
Participant Flow
This was a Phase 1, placebo-controlled, study to evaluate pharmacokinetics (PK), safety, and tolerability of nirsevimab compared to placebo in healthy participants conducted at a single center in China.
This study consisted of a screening period (28 days) and treatment period (151 days). A total of 24 participants were randomized in a 3:1 ratio to receive either nirsevimab or placebo.
Participant milestones
| Measure |
Nirsevimab
Participants received single fixed intramuscular (IM) dose of nirsevimab on Day 1.
|
Placebo
Participants received single fixed IM dose of placebo matching with nirsevimab on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
6
|
|
Overall Study
COMPLETED
|
18
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults
Baseline characteristics by cohort
| Measure |
Nirsevimab
n=18 Participants
Participants received single fixed IM dose of nirsevimab on Day 1.
|
Placebo
n=6 Participants
Participants received single fixed IM dose of placebo matching with nirsevimab on Day 1.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.2 years
STANDARD_DEVIATION 5.55 • n=5 Participants
|
29.8 years
STANDARD_DEVIATION 4.71 • n=7 Participants
|
29.3 years
STANDARD_DEVIATION 5.26 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
18 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose.Population: The PK population included all participants who received any dose of study treatment and had at least one measurable post-dose serum PK observation and for whom PK blood samples were assumed not to be affected by factors such as important protocol deviations (if any, determined prior to unblinding). Only participants who received nirsevimab were analyzed for PK outcome measures.
Serum samples were collected at indicated timepoints to determine the serum concentration of nirsevimab.
Outcome measures
| Measure |
Nirsevimab
n=18 Participants
Participants received single fixed IM dose of nirsevimab on Day 1.
|
|---|---|
|
Serum Concentrations of Nirsevimab
Pre-dose Day 1
|
NA micrograms/milliliter (mcg/mL)
Standard Deviation NA
NA indicates mean and standard deviation below the lower limit of quantitation of 0.5 mcg/mL
|
|
Serum Concentrations of Nirsevimab
Day 2
|
27.644 micrograms/milliliter (mcg/mL)
Standard Deviation 5.819
|
|
Serum Concentrations of Nirsevimab
Day 4
|
41.794 micrograms/milliliter (mcg/mL)
Standard Deviation 8.447
|
|
Serum Concentrations of Nirsevimab
Day 15
|
43.739 micrograms/milliliter (mcg/mL)
Standard Deviation 7.236
|
|
Serum Concentrations of Nirsevimab
Day 31
|
40.300 micrograms/milliliter (mcg/mL)
Standard Deviation 5.391
|
|
Serum Concentrations of Nirsevimab
Day 91
|
25.200 micrograms/milliliter (mcg/mL)
Standard Deviation 3.694
|
|
Serum Concentrations of Nirsevimab
Day 151
|
17.597 micrograms/milliliter (mcg/mL)
Standard Deviation 3.854
|
|
Serum Concentrations of Nirsevimab
Day 6
|
43.811 micrograms/milliliter (mcg/mL)
Standard Deviation 8.291
|
|
Serum Concentrations of Nirsevimab
Day 8
|
46.050 micrograms/milliliter (mcg/mL)
Standard Deviation 12.484
|
PRIMARY outcome
Timeframe: Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dosePopulation: The PK population included all participants who received any dose of study treatment and had at least one measurable post-dose serum PK observation and for whom PK blood samples were assumed not to be affected by factors such as important protocol deviations (if any, determined prior to unblinding). Only participants who received nirsevimab were analyzed for PK outcome measures.
Cmax for nirsevimab was directly calculated from the individual concentration-time curve.
Outcome measures
| Measure |
Nirsevimab
n=18 Participants
Participants received single fixed IM dose of nirsevimab on Day 1.
|
|---|---|
|
Maximum Observed Serum Concentration (Cmax) for Nirsevimab
|
46.882 mcg/mL
Geometric Coefficient of Variation 21.7
|
PRIMARY outcome
Timeframe: Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dosePopulation: The PK population included all participants who received any dose of study treatment and had at least one measurable post-dose serum PK observation and for whom PK blood samples were assumed not to be affected by factors such as important protocol deviations (if any, determined prior to unblinding). Only participants who received nirsevimab were analyzed for PK outcome measures.
Tmax for nirsevimab was directly calculated from the individual concentration-time curve.
Outcome measures
| Measure |
Nirsevimab
n=18 Participants
Participants received single fixed IM dose of nirsevimab on Day 1.
|
|---|---|
|
Time to Reach Maximum Observed Serum Concentration (Tmax) for Nirsevimab
|
6.99 days
Interval 4.91 to 29.9
|
PRIMARY outcome
Timeframe: Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dosePopulation: The PK population included all participants who received any dose of study treatment and had at least one measurable post-dose serum PK observation and for whom PK blood samples were assumed not to be affected by factors such as important protocol deviations (if any, determined prior to unblinding). Only participants who received nirsevimab were analyzed for PK outcome measures.
Area Under the Serum Concentration-Time Curve From Time 0 to 150 Days (AUC0-150) for Nirsevimab was calculated by linear up/log down trapezoidal summation.
Outcome measures
| Measure |
Nirsevimab
n=18 Participants
Participants received single fixed IM dose of nirsevimab on Day 1.
|
|---|---|
|
Area Under the Serum Concentration-Time Curve From Time 0 to 150 Days (AUC0-150) for Nirsevimab
|
4210.56 mcg*day/mL
Geometric Coefficient of Variation 13.6
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Days 31, 91 and 151Population: As-treated population included all participants who were randomized into the study and received any amount of study treatment.
ADA positive was defined as any participant with a positive ADA result available at any time, including baseline and all post-baseline measurements; otherwise ADA negative.
Outcome measures
| Measure |
Nirsevimab
n=18 Participants
Participants received single fixed IM dose of nirsevimab on Day 1.
|
|---|---|
|
Number of Participants With Positive Anti-Drug Antibody (ADA) of Nirsevimab
Baseline (Day 1)
|
0 Participants
|
|
Number of Participants With Positive Anti-Drug Antibody (ADA) of Nirsevimab
Day 31
|
0 Participants
|
|
Number of Participants With Positive Anti-Drug Antibody (ADA) of Nirsevimab
Day 91
|
0 Participants
|
|
Number of Participants With Positive Anti-Drug Antibody (ADA) of Nirsevimab
Day 151
|
0 Participants
|
Adverse Events
Nirsevimab
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nirsevimab
n=18 participants at risk
Participants received single fixed IM dose of nirsevimab on Day 1.
|
Placebo
n=6 participants at risk
Participants received single fixed IM dose of placebo matching with nirsevimab on Day 1.
|
|---|---|---|
|
Investigations
Haemoglobin decreased
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events were collected from first date of study treatment administration (Day 1) up to 151 days.
Treatment emergent adverse events were reported for As-treated population which included all participants who were randomized into the study and received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events were collected from first date of study treatment administration (Day 1) up to 151 days.
Treatment emergent adverse events were reported for As-treated population which included all participants who were randomized into the study and received any amount of study treatment.
|
|
Investigations
Urobilinogen urine increased
|
11.1%
2/18 • Number of events 2 • Treatment emergent adverse events were collected from first date of study treatment administration (Day 1) up to 151 days.
Treatment emergent adverse events were reported for As-treated population which included all participants who were randomized into the study and received any amount of study treatment.
|
0.00%
0/6 • Treatment emergent adverse events were collected from first date of study treatment administration (Day 1) up to 151 days.
Treatment emergent adverse events were reported for As-treated population which included all participants who were randomized into the study and received any amount of study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/18 • Treatment emergent adverse events were collected from first date of study treatment administration (Day 1) up to 151 days.
Treatment emergent adverse events were reported for As-treated population which included all participants who were randomized into the study and received any amount of study treatment.
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events were collected from first date of study treatment administration (Day 1) up to 151 days.
Treatment emergent adverse events were reported for As-treated population which included all participants who were randomized into the study and received any amount of study treatment.
|
|
Investigations
Blood creatinine increased
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events were collected from first date of study treatment administration (Day 1) up to 151 days.
Treatment emergent adverse events were reported for As-treated population which included all participants who were randomized into the study and received any amount of study treatment.
|
0.00%
0/6 • Treatment emergent adverse events were collected from first date of study treatment administration (Day 1) up to 151 days.
Treatment emergent adverse events were reported for As-treated population which included all participants who were randomized into the study and received any amount of study treatment.
|
|
Investigations
Complement factor decreased
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events were collected from first date of study treatment administration (Day 1) up to 151 days.
Treatment emergent adverse events were reported for As-treated population which included all participants who were randomized into the study and received any amount of study treatment.
|
0.00%
0/6 • Treatment emergent adverse events were collected from first date of study treatment administration (Day 1) up to 151 days.
Treatment emergent adverse events were reported for As-treated population which included all participants who were randomized into the study and received any amount of study treatment.
|
|
Investigations
Platelet count decreased
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events were collected from first date of study treatment administration (Day 1) up to 151 days.
Treatment emergent adverse events were reported for As-treated population which included all participants who were randomized into the study and received any amount of study treatment.
|
0.00%
0/6 • Treatment emergent adverse events were collected from first date of study treatment administration (Day 1) up to 151 days.
Treatment emergent adverse events were reported for As-treated population which included all participants who were randomized into the study and received any amount of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events were collected from first date of study treatment administration (Day 1) up to 151 days.
Treatment emergent adverse events were reported for As-treated population which included all participants who were randomized into the study and received any amount of study treatment.
|
0.00%
0/6 • Treatment emergent adverse events were collected from first date of study treatment administration (Day 1) up to 151 days.
Treatment emergent adverse events were reported for As-treated population which included all participants who were randomized into the study and received any amount of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place