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

Completed · Phase 1

Conditions studied: Corona Virus Disease

In brief

The study will assess pharmacokinetic (PK) comparability between different formulations of AZD7442, which is a combination of two individual monoclonal antibodies (mAbs), AZD8895 and AZD1061.

Key facts

Study ID

NCT05166421

Run by

AstraZeneca

People needed

224

Starts

2021-11-30

Expected to finish

2023-07-19

Last updated by the study team

2024-11-25

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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