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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-22

Study Completion Date

2021-11-18

Brief Summary

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

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Detailed Description

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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.

Conditions

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Evaluate PK Profile

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Nirsevimab

Nirsevimab single dose IM injection

Group Type EXPERIMENTAL

nirsevimab

Intervention Type BIOLOGICAL

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

Placebo

Placebo single dose IM injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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nirsevimab

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

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type OTHER

Other Intervention Names

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MEDI8897

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes