Study to Evaluate Pharmacokinetic Comparability Between AZD7442 Co-formulation (AZD8895 + AZD1061) vs AZD8895 and AZD1061 Individually in Adult Healthy Participants
NCT ID: NCT05166421
Last Updated: 2024-11-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
224 participants
INTERVENTIONAL
2021-11-30
2023-07-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Pharmacokinetic And Bioavailability Study of Intravenous Danoprevir in Healthy Volunteers
NCT01654211
Pharmacokinetic Comparability Study in Healthy Participants - PF-06881894 On-Body Injector Relative to Prefilled Syringe
NCT05194579
Study to Assess Adverse Events and How Oral ABBV-990 Moves Through the Body of Adult Healthy Participants
NCT05475821
Pharmacokinetics and Safety Following Administration of DWP16001
NCT05414591
A Study in Healthy Participants to Investigate Relative Bioavailability of AZD5004 in Three Solid Oral Formulations
NCT06996886
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Eligible healthy participants will be randomized in a 1:1:1 ratio between the 3 treatment groups. Each participant will receive AZD7442 as either a single intramuscular (IM) dose (co-formulation; AZD8895 + AZD1061), or as two separate IM doses of the individual mAbs (AZD8895 and then AZD1061) from either clonal cell line material or cell pool material.
Following an observation and PK and pharmacodynamic (PD) sample collection, post-dose, participants will be discharged from the Clinical Unit. During the Follow-up Period of approximately 1 year, participants will return as outpatient follow-up visits until Day 361.
The total duration of the study for a participant will be approximately 389 days comprising of a Screening Period that can last up to 28 days, Treatment Period of 1 day, and a Follow up Period of 360 days.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AZD7442 (co-formulation)
Participants will receive single dose of AZD7442 (co-formulation of AZD8895 + AZD1061) on Day 1.
AZD7442
AZD7442 will be administered via IM route.
AZD8895 and AZD1061 (clonal cell line material)
Participants will receive two separate doses of the individual mAbs (AZD8895 and then AZD1061) on Day 1.
AZD8895 (clonal cell line material)
AZD8895 will be administered via IM route.
AZD1061 (clonal cell line material)
AZD1061 will be administered via IM route.
AZD8895 and AZD1061 (cell pool material)
Participants will receive two separate doses of the individual mAbs (AZD8895 and then AZD1061) on Day 1.
AZD8895 (cell pool material)
AZD8895 will be administered via IM route.
AZD1061 (cell pool material)
AZD1061 will be administered via IM route.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AZD7442
AZD7442 will be administered via IM route.
AZD8895 (clonal cell line material)
AZD8895 will be administered via IM route.
AZD1061 (clonal cell line material)
AZD1061 will be administered via IM route.
AZD8895 (cell pool material)
AZD8895 will be administered via IM route.
AZD1061 (cell pool material)
AZD1061 will be administered via IM route.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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).
18 Years
79 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Anniston, Alabama, United States
Research Site
Cullman, Alabama, United States
Research Site
Scottsdale, Arizona, United States
Research Site
Chula Vista, California, United States
Research Site
La Mesa, California, United States
Research Site
Long Beach, California, United States
Research Site
North Hollywood, California, United States
Research Site
Edgewater, Florida, United States
Research Site
Lake Worth, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Meridian, Idaho, United States
Research Site
Berlin, New Jersey, United States
Research Site
Union, South Carolina, United States
Research Site
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D8850C00009
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.