NCT04791007

OB-002H Gel Administered Vaginally and Rectally in HIV-1 Seronegative Adults

A Monocentric Phase I Safety, Acceptability, and Pharmacokinetic Trial of OB-002H Gel Administered Vaginally and Rectally in Open-Label and Randomised, Double- Blind, Placebo-Controlled Cohorts of HIV-1 Seronegative Adults

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Orion Biotechnology Polska Sp. z o.o. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a monocentric phase I study in open-label and randomized, double-blind, placebo-controlled cohorts of HIV-1 seronegative adults to evaluate the safety, acceptability, and pharmacokinetic of OB-002H Gel administrated vaginally and rectally.

Conditions

• HIV Prevention

Interventions

Type	Name	Description
DRUG	OB-002	vaginal or rectal administration
DRUG	Placebo	vaginal or rectal administration

Timeline

• Start date: 2019-10-05
• Primary completion: 2020-04-06
• Completion: 2020-08-31
• First posted: 2021-03-10
• Last updated: 2021-03-18

Locations

1 site across 1 country: Poland