NCT05166421

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Corona Virus Disease

Interventions

Type	Name	Description
BIOLOGICAL	AZD7442	AZD7442 will be administered via IM route.
BIOLOGICAL	AZD8895 (clonal cell line material)	AZD8895 will be administered via IM route.
BIOLOGICAL	AZD1061 (clonal cell line material)	AZD1061 will be administered via IM route.
BIOLOGICAL	AZD8895 (cell pool material)	AZD8895 will be administered via IM route.
BIOLOGICAL	AZD1061 (cell pool material)	AZD1061 will be administered via IM route.

Timeline

• Start date: 2021-11-30
• Primary completion: 2023-07-19
• Completion: 2023-07-19
• First posted: 2021-12-22
• Last updated: 2024-11-25
• Results posted: 2024-11-25

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study