The purpose of this study is to evaluate the Pharmacokinetics, Safety, Tolerability of Nirsevimab in Healthy Chinese Adults.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
24
Drug: injection, a single fixed IM dose on day 1 only.
Placebo: injection, 0.9% (w/v) saline, a single fixed IM dose on day 1 only.
Research Site
Shanghai, China
Serum Concentrations of Nirsevimab
Serum samples were collected at indicated timepoints to determine the serum concentration of nirsevimab.
Time frame: Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose.
Maximum Observed Serum Concentration (Cmax) for Nirsevimab
Cmax for nirsevimab was directly calculated from the individual concentration-time curve.
Time frame: Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose
Time to Reach Maximum Observed Serum Concentration (Tmax) for Nirsevimab
Tmax for nirsevimab was directly calculated from the individual concentration-time curve.
Time frame: 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
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.
Time frame: Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose
Number of Participants With Positive Anti-Drug Antibody (ADA) of Nirsevimab
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.
Time frame: Baseline (Day 1) and Days 31, 91 and 151
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.