Study to Evaluate Pharmacokinetic Comparability Between AZD7442 Co-formulation (AZD8895 + AZD1061) vs AZD8895 and AZD1061 Individually in Adult Healthy Participants
Status and phase
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Details and patient eligibility
About
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.
Full description
This is a randomized, open label, three-arm, single dose, parallel group, multi-center, PK comparability study.
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.
Enrollment
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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).
Trial design
Primary purpose
Allocation
Interventional model
Masking
224 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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