The Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of BWC0977 in Healthy Adult Volunteers

PHASE1TerminatedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

August 30, 2023

Primary Completion Date

January 30, 2024

Study Completion Date

February 15, 2024

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 a matching placebo. MAD Cohorts: Two participants in each cohort will receive matching placebo.~Other Names:~• Compounded solution minus BWC0977"

Trial Locations (1)

5000

CMAX Clinical Research, Adelaide

Sponsors
All Listed Sponsors
collaborator

Avance Clinical Pty Ltd.

INDUSTRY

lead

Bugworks Research Inc.

INDUSTRY

NCT05942820 - The Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of BWC0977 in Healthy Adult Volunteers | Biotech Hunter | Biotech Hunter