Evaluate the Safety & Assess Local and Systemic PK of DS003 Vaginal Tablets Administered to Healthy HIV-negative Women

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

November 18, 2015

Primary Completion Date

August 26, 2016

Study Completion Date

August 26, 2016

Conditions
HIV
Interventions
DRUG

DS003 vaginal tablet

The trial will be conducted in three cohorts of 12 women each. In each cohort, participants will be randomised in a 3:1 ratio to receive either DS003 or placebo on Day 0 and Day 17. In each cohort, therefore, 9 participants will receive DS003 vaginal tablets and 3 participants will receive placebo vaginal tablets.

DRUG

Placebo

All Listed Sponsors
lead

International Partnership for Microbicides, Inc.

INDUSTRY

NCT02877979 - Evaluate the Safety & Assess Local and Systemic PK of DS003 Vaginal Tablets Administered to Healthy HIV-negative Women | Biotech Hunter | Biotech Hunter