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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2024-11-25

Study results available
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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.

Conditions

  • Corona Virus Disease

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2023-07-19
Completion
2023-07-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05166421 on ClinicalTrials.gov