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Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC)

NCT05280717 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2024-09-19

Study results available
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Summary

This clinical pharmacology study will evaluate the relative bioavailability, safety, and tolerability of two different concentrations of sotrovimab injections administered at different injection sites in male or female healthy participants aged 18 to 65 years. The study will be conducted in three parts (Part A, an optional Part B and Part C). Part B and Part C (cohort 2) were optional so they were not initiated. Part C cohort 1 was discontinued early in the context of evolving variants with increased fold changes in the in vitro half maximal inhibitory concentration (IC50) and uncertainty in the clinical relevance of these changes.

Conditions

  • Covid19

Interventions

BIOLOGICAL

sotrovimab

via IM injection

BIOLOGICAL

sotrovimab

via IM injection

BIOLOGICAL

sotrovimab

via IM injection

BIOLOGICAL

sotrovimab

via IM injection

BIOLOGICAL

sotrovimab

via IM injection

BIOLOGICAL

sotrovimab

via IV injection

BIOLOGICAL

sotrovimab

via IV infusion

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Vir Biotechnology, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-03-28
Primary Completion
2023-04-05
Completion
2023-11-06
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 NCT05280717 on ClinicalTrials.gov