Status:
COMPLETED
Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
IQVIA RDS (Shanghai) Co., Ltd.
Conditions:
Evaluate PK Profile
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 Chines...
Eligibility Criteria
Inclusion
- Age 18 to 45 years
- Weight ≥ 45 kg and ≤ 110 kg and Body Mass Index of 19 to 26 kg/m2
- Healthy Chinese subjects (both male and female)
- Normotensive
- Normal electrocardiogram (ECG) within 28 days prior to Day 1
Exclusion
- 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
Key Trial Info
Start Date :
June 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04840849
Start Date
June 22 2021
End Date
November 18 2021
Last Update
November 2 2023
Active Locations (1)
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1
Research Site
Shanghai, China, 200040