CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 48 enrolled
Drug / intervention
sotrovimab +3 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.

Search/NCT04988152
NCT04988152Phase 1Completed
CompareCT.gov

A Phase I, Single-blind, Randomized, Single-dose Clinical Pharmacology Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Sotrovimab vs Placebo by Intravenous or Intramuscular Administration in Healthy Japanese and Caucasian Participants

Vir Biotechnology, Inc.·interventional·Posted Aug 3, 2021·Updated Jun 7, 2024

In Brief

A Phase 1 clinical trial evaluating sotrovimab and Placebo to Biologic for Covid19. Completed, enrolled 48 participants across 2 sites.

Detailed Summary

This is a Phase I single-dose study to investigate the pharmacokinetics, safety, and tolerability of sotrovimab vs placebo by intravenous or intramuscular administration in healthy Japanese and Caucasian participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19
CountriesUnited States
CollaboratorsGlaxoSmithKline

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedAug 3, 2021
Enrollment StartJul 6, 2021
Primary CompletionSep 2, 2021
Study CompletionDec 7, 2021
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 4.9 years ago

Interventions

sotrovimabbiological

sotrovimab IV infusion, single dose

Placebo to Biologicother

Sterile 0.9% (w/v) sodium chloride solution

sotrovimabbiological

Sotrovimab IM injection, single dose

Placebo to Biologicother

Sterile 0.9% (w/v) sodium chloride solution