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

PHASE1CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

November 5, 2021

Primary Completion Date

December 29, 2022

Study Completion Date

May 28, 2023

Conditions
Infectious DiseasesBacterial Infections
Interventions
DRUG

BWC0977

"SAD Cohorts: Double-blind dosing will occur. Six participants will receive single doses of BWC0977. The dose escalation steps may be altered following review of the safety data upon completion of each cohort.~MAD Cohorts: Double blind dosing will occur. Six participants in each cohort will receive multiple doses of BWC0977. The dose escalation steps may be altered following review of the safety data upon completion of each cohort. Dosing will commence on the morning of Day 1. Dosing frequency to be confirmed based on safety, tolerability and PK data from SAD cohorts. Daily dosing will continue for a total of 10 consecutive days."

DRUG

Placebo

SAD Cohorts: Two participants in each cohort will receive matching placebo. MAD Cohorts: Two participants in each cohort will receive matching placebo.

Trial Locations (1)

5000

CMAX Clinical Research, Adelaide

Sponsors
All Listed Sponsors
collaborator

Avance Clinical Pty Ltd.

INDUSTRY

lead

Bugworks Research Inc.

INDUSTRY