NCT02877979

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

A Double-blind, Randomised, Placebo-controlled, Dose Escalation Trial to Evaluate the Safety and to Assess Local and Systemic Pharmacokinetics of DS003 Vaginal Tablets Administered to Healthy HIV-negative Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: International Partnership for Microbicides, Inc. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A double-blind, randomised, placebo-controlled, dose escalation trial to evaluate the safety and to assess local and systemic pharmacokinetics of ds003 vaginal tablets administered to healthy HIV-negative women.

Conditions

• HIV

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-11-18
• Primary completion: 2016-08-26
• Completion: 2016-08-26
• First posted: 2016-08-25
• Last updated: 2017-08-24