Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults - PK/ADA

Study identifier:D5290C00007

ClinicalTrials.gov identifier:NCT04840849

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults

Medical condition

Evaluate PK profile

Phase

Phase 1

Healthy volunteers

Yes

Study drug

-

Sex

All

Actual Enrollment

24

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: 22 Jun 2021
Primary Completion Date: 18 Nov 2021
Study Completion Date: 18 Nov 2021

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Other

Verification:

Verified 01 Dec 2022 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

IQVIA RDS (Shanghai) Co., Ltd.

Inclusion and exclusion criteria