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

NCT04840849 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-11-02

Study results available
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Summary

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

Conditions

  • Evaluate PK Profile

Interventions

BIOLOGICAL

nirsevimab

Drug: injection, a single fixed IM dose on day 1 only.

OTHER

Placebo

Placebo: injection, 0.9% (w/v) saline, a single fixed IM dose on day 1 only.

Sponsors & Collaborators

  • IQVIA RDS (Shanghai) Co., Ltd.

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-22
Primary Completion
2021-11-18
Completion
2021-11-18

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04840849 on ClinicalTrials.gov