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OB-002H

Status
Completed
Phase
I
Objective

This is a safety and acceptability study of the OB-002H gel which is a topical formulation of OB-002 (5P12-RANTES), a novel chemokine analogue that binds to the CCR5 receptors in order to prevent HIV infection. 

 

Last updated: May 11, 2021

Prevention Option(s)
Microbicides
Study Design
Placebo-controlled
Randomized
Open label
Double-blind
Arms and Assigned Interventions
Description
Experimental: Single dose administration (Part 1) the dose of the drug (4g OB-002H (8.0 mg/g)) administrated once vaginally or rectally Drug: OB-002 vaginal or rectal administration
ARMs
Experimental
Description
Experimental: Multidose administration (Part 2) the dose of the drug (4g OB-002H (8.0 mg/g)) or placebo administered vaginally through five consecutive days Drug: OB-002 vaginal or rectal administration Drug: Placebo vaginal or rectal administration
ARMs
Placebo Comparator
Results
Evaluation of the Safety, Acceptability, and Pharmacokinetic Profile of a Gel Formulation of OB-002 in Healthy Volunteers
Official Code
NCT04791007
Trial Sponsors
SCOPE International AG
Product Developers
Orion Biotechnology Polska Sp. z o.o. (OB-002H-101)
October 2019
August 2020
Date of Enrollment Completion
April 6, 2020
Enrollment
60
18
Years
45
Years
Population
MSM
Women
Sites

Site(s)-Poland

Poland