At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
nirsevimab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults
In Brief
A Phase 1 clinical trial evaluating nirsevimab and Placebo for Evaluate PK Profile. Completed, enrolled 24 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the Pharmacokinetics, Safety, Tolerability of Nirsevimab in Healthy Chinese Adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEvaluate PK Profile
CountriesChina
CollaboratorsIQVIA RDS (Shanghai) Co., Ltd.
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedApr 2021
Enrollment StartJun 2021
Primary CompletionNov 2021
TodayJul 2026
First PostedApr 12, 2021
Enrollment StartJun 22, 2021
Primary CompletionNov 18, 2021
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 5.2 years ago
Interventions
nirsevimabbiological
Drug: injection, a single fixed IM dose on day 1 only.
Placeboother
Placebo: injection, 0.9% (w/v) saline, a single fixed IM dose on day 1 only.