Phase 1
Completed N=24
Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults
Evaluate PK Profile
Source: ClinicalTrials.gov NCT04840849 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: Serum Concentrations of Nirsevimab — NA; 27.644; 41.794; 43.811 micrograms/milliliter (mcg/mL)
Summary
The purpose of this study is to evaluate the Pharmacokinetics, Safety, Tolerability of Nirsevimab in Healthy Chinese Adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Concentrations of Nirsevimab |
NA; 27.644; 41.794; 43.811; 46.050; 43.739 | — |
| PRIMARY Maximum Observed Serum Concentration (Cmax) for Nirsevimab |
46.882 | — |
| PRIMARY Time to Reach Maximum Observed Serum Concentration (Tmax) for Nirsevimab |
6.99 | — |
| PRIMARY Area Under the Serum Concentration-Time Curve From Time 0 to 150 Days (AUC0-150) for Nirsevimab |
4210.56 | — |
| SECONDARY Number of Participants With Positive Anti-Drug Antibody (ADA) of Nirsevimab |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 to 45 years
- Weight ≥ 45 kg and ≤ 110 kg and Body Mass Index of 19 to 26 kg/m2
- Healthy Chinese subjects (both male and female)
- Normotensive
- Normal electrocardiogram (ECG) within 28 days prior to Day 1
Exclusion Criteria
- Acute illness at study entry (pre-dose on Day 1)
- Fever ≥99.5°F (37.5°C) on day of dosing
- Any drug therapy within 14 days prior to Day 1 (except contraceptives).
- Receipt of immunoglobulin or blood products within 6 months prior to study entry.
- Receipt of any investigational drug therapy within 120 days prior to investigational product dosing or planned to receive any investigational drug therapy within 150 days after investigational product dosing.
- Previous receipt of any marketed or investigational mAb.
- Previous vaccination against RSV.
- History of immunodeficiency or receipt of immunosuppressive medications during the prior year.
- History of asthma.
- History of autoimmune disorder.
- Evidence of any systemic disease on physical examination.
- Evidence of infection with hepatitis A, B, or C virus, syphilis, or human immunodeficiency virus.
- Any clinically significant abnormal laboratory assessments at screening.
- Pregnant or nursing mother.
- Alcohol or drug abuse
Data sourced from ClinicalTrials.gov (NCT04840849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.