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

NCT05166421

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Corona Virus Disease

Interventions: AZD7442, AZD8895 (clonal cell line material), AZD1061 (clonal cell line material), AZD8895 (cell pool material), AZD1061 (cell pool material)

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 79 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility 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).

Locations (14)

Anniston, Alabama, United States
Cullman, Alabama, United States
Scottsdale, Arizona, United States
Chula Vista, California, United States
La Mesa, California, United States
Long Beach, California, United States
North Hollywood, California, United States
Edgewater, Florida, United States
Lake Worth, Florida, United States
Orlando, Florida, United States
Meridian, Idaho, United States
Berlin, New Jersey, United States
Union, South Carolina, United States
Houston, Texas, United States