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

NCT04840849 | Completed Phase 1 Results

• 1 other identifier: D5290C00007
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Evaluate PK Profile

Keywords

PK; safety; tolerability; Nirsevimab; healthy Chinese Adults; Respiratory Syncytial Viral (RSV)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Number of Participants With Positive Anti-Drug Antibody (ADA) of Nirsevimab

  Baseline (Day 1) and Days 31, 91 and 151

Study Arms (2)

Nirsevimab

EXPERIMENTAL

Nirsevimab single dose IM injection

Biological: nirsevimab

Placebo

PLACEBO COMPARATOR

Placebo single dose IM injection

Other: Placebo

Interventions

nirsevimab BIOLOGICAL

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

Also known as: MEDI8897

Nirsevimab

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• IQVIA RDS (Shanghai) Co., Ltd.: collaborator

Study Sites (1)

Research Site

Shanghai, 200040, China

Location

Related Links

• CSP\_Redacted
• SAP\_Redacted
• CSR\_Synopsis\_Redacted

MeSH Terms

Interventions

nirsevimab

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 12, 2021
• Study Start: June 22, 2021
• Primary Completion: November 18, 2021
• Study Completion: November 18, 2021
• Last Updated: November 2, 2023
• Results First Posted: November 2, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

CN (1)