At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 224 enrolled
Drug / intervention
AZD7442 +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating AZD7442, AZD8895 (clonal cell line material), and 3 other interventions for Corona Virus Disease. Completed, enrolled 224 participants across 14 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCorona Virus Disease
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
Enrollment StartNov 2021
First PostedDec 2021
Primary CompletionJul 2023
TodayJul 2026
First PostedDec 22, 2021
Enrollment StartNov 30, 2021
Primary CompletionJul 19, 2023
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 4.5 years ago
Interventions
AZD7442biological
AZD7442 will be administered via IM route.
AZD8895 (clonal cell line material)biological
AZD8895 will be administered via IM route.
AZD1061 (clonal cell line material)biological
AZD1061 will be administered via IM route.
AZD8895 (cell pool material)biological
AZD8895 will be administered via IM route.
AZD1061 (cell pool material)biological
AZD1061 will be administered via IM route.