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

Phase 0 Completed 60 enrolled Orion Biotechnology Scope International AG · collab

RandomizedSequentialDouble-blindPrevention

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.

Timeline

Start: 2019-10-05
Primary completion: 2020-04-06
Completion: 2020-08-31

Publications

McGowan IM, Tzakis N, Kosak B, Korczak B, Engstrom J, Tomaszewska-Kiecana M, Hartley O. Evaluation of the Safety, Acceptability, and Pharmacokinetic Profile of a Gel Formulation of OB-002 in Healthy Volunteers. AIDS Res Hum Retroviruses. 2021 Jun;37(6):453-460. doi: 10.1089/AID.2021.0010. Epub 2021 Apr 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	OB-002	Unknown	32 mg	Other

Indications

No indication recorded.