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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Evaluate PK Profile

Treatments: Other: Placebo; Biological: nirsevimab

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04840849

D5290C00007

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 18 to 45 years
2. Weight ≥ 45 kg and ≤ 110 kg and Body Mass Index of 19 to 26 kg/m2
3. Healthy Chinese subjects (both male and female)
4. Normotensive
5. Normal electrocardiogram (ECG) within 28 days prior to Day 1

Exclusion criteria

1. Acute illness at study entry (pre-dose on Day 1)
2. Fever ≥99.5°F (37.5°C) on day of dosing
3. Any drug therapy within 14 days prior to Day 1 (except contraceptives).
4. Receipt of immunoglobulin or blood products within 6 months prior to study entry.
5. 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.
6. Previous receipt of any marketed or investigational mAb.
7. Previous vaccination against RSV.
8. History of immunodeficiency or receipt of immunosuppressive medications during the prior year.
9. History of asthma.
10. History of autoimmune disorder.
11. Evidence of any systemic disease on physical examination.
12. Evidence of infection with hepatitis A, B, or C virus, syphilis, or human immunodeficiency virus.
13. Any clinically significant abnormal laboratory assessments at screening.
14. Pregnant or nursing mother.
15. Alcohol or drug abuse

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups, including a placebo group

Nirsevimab

Experimental group

Description:

Nirsevimab single dose IM injection

Treatment:

Biological: nirsevimab

Placebo

Placebo Comparator group

Description:

Placebo single dose IM injection

Treatment:

Other: Placebo