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

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

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.

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

Conditions
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Evaluate PK Profile

Intervention / Treatment
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* Biological: nirsevimab
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nirsevimab<br>Nirsevimab single dose IM injection | Biological: nirsevimab<br>* Drug: injection, a single fixed IM dose on day 1 only.<br>* Other names: MEDI8897;|
| Placebo Comparator: Placebo<br>Placebo single dose IM injection | Other: Placebo<br>* Placebo: injection, 0.9% (w/v) saline, a single fixed IM dose on day 1 only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Concentrations of Nirsevimab | Serum samples were collected at indicated timepoints to determine the serum concentration of nirsevimab. | Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose. | 
| Maximum Observed Serum Concentration (Cmax) for Nirsevimab | Cmax for nirsevimab was directly calculated from the individual concentration-time curve. | Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose | 
| Time to Reach Maximum Observed Serum Concentration (Tmax) for Nirsevimab | Tmax for nirsevimab was directly calculated from the individual concentration-time curve. | Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose | 
| Area Under the Serum Concentration-Time Curve From Time 0 to 150 Days (AUC0-150) for Nirsevimab | Area Under the Serum Concentration-Time Curve From Time 0 to 150 Days (AUC0-150) for Nirsevimab was calculated by linear up/log down trapezoidal summation. | Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Positive Anti-Drug Antibody (ADA) of Nirsevimab | ADA positive was defined as any participant with a positive ADA result available at any time, including baseline and all post-baseline measurements; otherwise ADA negative. | Baseline (Day 1) and Days 31, 91 and 151 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PK, safety, tolerability, Nirsevimab, healthy Chinese Adults, Respiratory Syncytial Viral (RSV)