Protocol Title: 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
IPM 042 is a double-blinded, randomized, placebo-controlled, dose-escalating Phase I trial to determine the safety, pharmacokinetics and pharmacodynamics of the DS003 vaginal tablet in healthy, HIV-negative women. 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. Participants assigned to the active tablet in the first cohort will receive a 1 mg tablet. Participants assigned to the active tablet in the two successive cohorts will receive tablets containing 3 mg and 10 mg, respectively. Each cohort will not proceed until safety data from the previous cohort have been reviewed.
- ClinicalTrials ID: NCT02877979
Participating Research Centers
- SGS Life Science Services — Antwerp, Belgium
Publications, presentations or other scientific data
- Friend et al. Safety and Pharmacokinetics of DS003 When Administered to Women as a Vaginal Tablet [poster presentation]. HIV R4P 2018. See abstract.
- Nuttall et al. Pharmacodynamic Activity of DS003, a Novel gp120 Blocker, When Administered to Women as a Vaginal Tablet [poster presentation]. HIV R4P 2018. See abstract.