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A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of BWC0977 in Healthy Volunteers

Bacterial Infections Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled, Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of BWC0977 in Healthy Adult Volunteers

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single and multiple intravenous doses of BWC0977 when administered to healthy adult volunteers.

Clinical Trial Description

This Phase 1 study is designed to assess the safety, tolerabilty and pharmcokinetics of single and multiple intravenous doses of BWC0977 when administered to healthy adult volunteers. This is a randomized double-blind, placebo-controlled, ascending dose, multi-cohort trial. A total of 64 healthy volunteers are expected to be enrolled into 8 Cohorts. The study will be conducted in two phases: A single ascending dose (SAD) phase, followed by a multiple ascending dose (MAD) phase. In SAD, participants in Cohorts 1 - 5 will receive one dose of BWC0977 or placebo. In MAD, participants in Cohorts 6 - 8 will receive multiple doses of BWC0977 or placebo for 10 consecutive days at a dose deemed safe and tolerable as determined in the preceding SAD Cohorts. In both parts sequential cohorts will be exposed to increasing doses of BWC0977. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05088421
Study type Interventional
Source Bugworks Research Inc.
Contact
Status Completed
Phase Phase 1
Start date November 5, 2021
Completion date May 28, 2023
View Details
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