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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04840849
Recruitment Status : Completed
First Posted : April 12, 2021
Last Update Posted : December 8, 2021
Sponsor:
Collaborator:
IQVIA RDS (Shanghai) Co., Ltd.
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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
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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
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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
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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
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04840849


Locations
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China
Research Site
Shanghai, China, 200040
Sponsors and Collaborators
AstraZeneca
IQVIA RDS (Shanghai) Co., Ltd.
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04840849    
Other Study ID Numbers: D5290C00007
First Posted: April 12, 2021    Key Record Dates
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

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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)