Clinical trial NCT04840849: Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Evaluate PK Profile
Keywords: PK
safety
tolerability
Nirsevimab
healthy Chinese Adults
Respiratory Syncytial Viral (RSV)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: IQVIA RDS (Shanghai) Co., Ltd.
First posted: 2021-04-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum Concentrations of Nirsevimab
timeFrame: Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose.
measure: Maximum Observed Serum Concentration (Cmax) for Nirsevimab
timeFrame: Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose
measure: Time to Reach Maximum Observed Serum Concentration (Tmax) for Nirsevimab
timeFrame: Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose
measure: Area Under the Serum Concentration-Time Curve From Time 0 to 150 Days (AUC0-150) for Nirsevimab
timeFrame: Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose
Secondary outcomes:
measure: Number of Participants With Positive Anti-Drug Antibody (ADA) of Nirsevimab
timeFrame: Baseline (Day 1) and Days 31, 91 and 151
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Research Site
Study officials:
References: