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

• ClinicalTrials.gov Identifier: NCT04840849
• Recruitment Status: Completed
• First Posted: April 12, 2021
• Last Update Posted: December 8, 2021
• Sponsor: AstraZeneca
• Collaborator: IQVIA RDS (Shanghai) Co., Ltd.
• Information provided by (Responsible Party): AstraZeneca

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Evaluate PK Profile	Biological: nirsevimab; Other: Placebo	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults
• Actual Study Start Date: June 22, 2021
• Actual Primary Completion Date: November 18, 2021
• Actual Study Completion Date: November 18, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Nirsevimab; Nirsevimab single dose IM injection	Biological: nirsevimab; Drug: injection, a single fixed IM dose on day 1 only.; Other Name: MEDI8897
Placebo Comparator: Placebo; Placebo single dose IM injection	Other: Placebo; Placebo: injection, 0.9% (w/v) saline, a single fixed IM dose on day 1 only.

Outcome Measures

Primary Outcome Measures :

1. Summary of nirsevimab serum concentrations [ Time Frame: Through Day 151 ]
   The serum concentration data and the estimated PK parameters will provide information on the time course and extent of nirsevimab serum exposure in the study population following a single administration. Pharmacokinetic parameters will be calculated using the Phoenix WinNonlin software using a noncompartmental approach.
2. PK parameters - Cmax (maximum observed concentration) [ Time Frame: Through Day 151 ]
   The serum concentration data and the estimated PK parameters will provide information on the time course and extent of nirsevimab serum exposure in the study population following a single administration. Pharmacokinetic parameters will be calculated using the Phoenix WinNonlin software using a noncompartmental approach.
3. PK parameters - Tmax (time to Cmax) [ Time Frame: Through Day 151 ]
   The serum concentration data and the estimated PK parameters will provide information on the time course and extent of nirsevimab serum exposure in the study population following a single administration. Pharmacokinetic parameters will be calculated using the Phoenix WinNonlin software using a noncompartmental approach.
4. PK parameters - AUC0-150 (area under the concentration-time curve from time 0 to 150 days) [ Time Frame: Through Day 151 ]
   The serum concentration data and the estimated PK parameters will provide information on the time course and extent of nirsevimab serum exposure in the study population following a single administration. Pharmacokinetic parameters will be calculated using the Phoenix WinNonlin software using a noncompartmental approach.

Secondary Outcome Measures :

1. Occurrence of all treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), adverse events of special interest (AESIs), and new onset chronic diseases (NOCDs). Clinical laboratory assessments, vital signs [ Time Frame: Through Day 151 ]
2. Incidence of ADA to nirsevimab in serum [ Time Frame: Through Day 151 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

China

Research Site

Shanghai, China, 200040

Sponsors and Collaborators

AstraZeneca

IQVIA RDS (Shanghai) Co., Ltd.

More Information

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT04840849
• Other Study ID Numbers: D5290C00007
• First Posted: April 12, 2021
• Last Update Posted: December 8, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• 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.
• URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AstraZeneca:

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