Study to Evaluate Pharmacokinetic Comparability Between AZD7442 Co-formulation (AZD8895 + AZD1061) vs AZD8895 and AZD1061 Individually in Adult Healthy Participants

Study identifier:D8850C00009

ClinicalTrials.gov identifier:NCT05166421

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Phase 1, Randomized, Open label, Three-arm, Single Dose, Parallel Group Study to Compare AZD7442 (AZD8895 + AZD1061) Pharmacokinetic Exposure Following Intramuscular Administration as a Co-formulation versus Administration from Two Separate Vials of the Individual Monoclonal Antibodies in Adult Healthy Participants

Medical condition

Corona virus disease

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Sex

All

Actual Enrollment

224

Study type

Interventional

Age

18 Years - 79 Years

Date

Study Start Date: 30 Nov 2021

Primary Completion Date: 19 Jul 2023

Study Completion Date: 19 Jul 2023

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Healthy participants according to medical history, physical examination, and baseline safety laboratory tests.
- Documented negative results of a Severe Acute Respiratory Syndrome Corona Virus 2 reverse transcriptase polymerase chain reaction (SARS-CoV-2 RT-PCR) test collected ≤ 3 days prior to investigational medicinal drug (IMP) dose administration (Day 1) or a negative rapid SARS-CoV-2 antigen test on Day 1 (pre-dose).
- Able to complete the Follow-up period up to Day 361 as required by the protocol.
- Body weight ≥ 50 kg to ≤ 110 kg at screening and a Body mass index ≥ 18.0 to ≤ 30 kg/m^2 at the time of the Screening Visit.

Exclusion Criteria

- Known history of allergy or reaction to any component of AZD7442 (AZD8895 + AZD1061).
- History of infection with SARS or Middle East Respiratory Syndrome.
- Positive SARSCoV-2 result based on available data at screening or at Day 1.
- Any clinical signs and symptoms consistent with Corona virus disease 2019 (COVID-19), eg, fever, dry cough, dyspnea, sore throat, fatigue, or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on admission.
- History of clinically significant bleeding disorder.
- Active infection with hepatitis B or C or positive test for hepatitis C or for hepatitis B surface antigen at screening.
- Immunodeficiency due to illness, including HIV infection, or due to drugs, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone.
- Any other significant disease, disorder, or finding that may significantly increase the risk to the participant because of participation in the study
-Any prior receipt of another mAb indicated for the prevention or treatment of SARS CoV-2 or COVID-19.
- Receipt of a mAb within 6 months or 5 antibody half-lives.
- Receipt of a COVID-19 vaccination ≤ 14 days before IMP administration (Day 1) or plan to receive a COVID-19 vaccination ≤ 14 days after IMP dose (such participants can subsequently be included in the study once they have reached > 14 days after their last dose of vaccine).

No locations available

Arms	Assigned Interventions
Experimental: AZD7442 (co-formulation) Participants will receive single dose of AZD7442 (co-formulation of AZD8895 + AZD1061) on Day 1.	Biological/Vaccine: AZD7442 AZD7442 will be administered via IM route.
Active Comparator: AZD8895 and AZD1061 (clonal cell line material) Participants will receive two separate doses of the individual mAbs (AZD8895 and then AZD1061) on Day 1.	Biological/Vaccine: AZD8895 (clonal cell line material) AZD8895 will be administered via IM route. Biological/Vaccine: AZD1061 (clonal cell line material) AZD1061 will be administered via IM route.
Active Comparator: AZD8895 and AZD1061 (cell pool material) Participants will receive two separate doses of the individual mAbs (AZD8895 and then AZD1061) on Day 1.	Biological/Vaccine: AZD8895 (cell pool material) AZD8895 will be administered via IM route. Biological/Vaccine: AZD1061 (cell pool material) AZD1061 will be administered via IM route.

Documents available

Redacted_CSR_Synopsis
Download
Redacted_CSP
Download
Redacted_SAP
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]