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DuoGel

Status
Ongoing
Phase
I
Objective

The purpose of this study is describe the safety and single-dose pharmacokinetics of rectally-administered IQP (ImQuest Pharmaceuticals)-0528 (DuoGel) in plasma, rectal tissue biopsies, vaginal tissue biopsies, rectal fluid and cervicovaginal fluid as well as to assess the luminal distribution of IQP-0528 in the rectum. Sixteen healthy volunteers will receive a single rectal dose of DuoGel, followed by blood, tissue and fluid sampling over the following 72 hours.

Prevention Option(s)
Microbicides
Study Design
Open label
Arms and Assigned Interventions
Description
IQP-0528 1% gel administered rectally one time
Mode of Delivery
Gel
Products
IQP-0528
ARMs
Experimental
November 2017
May 2019
Enrollment
16
18
Years
Population
Women
Men
Sites

Johns Hopkins University

Baltimore, Maryland
United States of America