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ImQuest DuoGel

Status
Completed
Phase
I
Principal Investigator(s)
Craig Hendrix, MD
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.

 

 

Last updated April 30, 2021

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
June 2019
Enrollment
16
18
Years
Population
Men
Women
Sites

Johns Hopkins University

Baltimore, Maryland
United States of America