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A Study to Investigate the PK, Safety, and Tolerability of Sotrovimab vs Placebo Administered IV or IM in Japanese and Caucasian Participants

NCT04988152 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-06-07

Study results available
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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.

Conditions

  • Covid19

Interventions

BIOLOGICAL

sotrovimab

sotrovimab IV infusion, single dose

OTHER

Placebo to Biologic

Sterile 0.9% (w/v) sodium chloride solution

BIOLOGICAL

sotrovimab

Sotrovimab IM injection, single dose

OTHER

Placebo to Biologic

Sterile 0.9% (w/v) sodium chloride solution

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Vir Biotechnology, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-07-06
Primary Completion
2021-09-02
Completion
2021-12-07
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 NCT04988152 on ClinicalTrials.gov