Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults

Phase 1

Completed

Brief Summary: The purpose of this study is to evaluate the Pharmacokinetics, Safety, Tolerability of Nirsevimab in Healthy Chinese Adults.

Detailed Description: This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the PK, safety and tolerability, and ADA of nirsevimab when administered as a single fixed IM dosage to healthy Chinese adult subjects. Enrolment is planned at a single study center in China. Approximately 24 subjects will be randomly assigned in a 3:1 ratio to receive nirsevimab (n = 18) or placebo (n = 6). All subjects will be followed for approximately 150 days after dosing to assess safety, PK, and ADA response.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Nirsevimab	nirsevimab	Nirsevimab single dose IM injection
Placebo	Placebo	Placebo single dose IM injection

Primary Outcome Measures

Name	Time	Method
Maximum Observed Serum Concentration (Cmax) for Nirsevimab	Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose	Cmax for nirsevimab was directly calculated from the individual concentration-time curve.
Time to Reach Maximum Observed Serum Concentration (Tmax) for Nirsevimab	Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose	Tmax for nirsevimab was directly calculated from the individual concentration-time curve.
Serum Concentrations of Nirsevimab	Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose.	Serum samples were collected at indicated timepoints to determine the serum concentration of nirsevimab.
Area Under the Serum Concentration-Time Curve From Time 0 to 150 Days (AUC0-150) for Nirsevimab	Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Positive Anti-Drug Antibody (ADA) of Nirsevimab	Baseline (Day 1) and Days 31, 91 and 151	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.