NCT04988152

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Vir Biotechnology, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of a single fixed dose of sotrovimab administered intravenously (IV) or via intramuscular (IM) injection in Japanese and Caucasian healthy volunteers. This study will occur in two parts (Part 1 and Part 2). Part 1: Healthy Japanese and Caucasian participants will be randomized in a 4:1 ratio to receive a single IV infusion of sotrovimab or volume-matched saline placebo on Day 1. Participants will be blinded to study intervention. Safety, tolerability, immunogenicity, and PK of IV sotrovimab will be evaluated. Part 2: Healthy Japanese and Caucasian participants will be randomized in a 4:1 ratio to receive a single IM dose of sotrovimab or volume-matched saline placebo on Day 1. Participants will be blinded to study intervention. Safety, tolerability, immunogenicity, and PK of IM sotrovimab will be evaluated. The data from this study will be used to supplement data available from other clinical trials that were conducted in non-Japanese participants.

Conditions

• Covid19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-07-06
• Primary completion: 2021-09-02
• Completion: 2021-12-07
• First posted: 2021-08-03
• Last updated: 2024-06-07
• Results posted: 2024-06-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study