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
DescriptionIQP-0528 1% gel administered rectally one time
Mode of DeliveryGel
ARMsExperimental
Official Code:
NCT03082690
Start Date
End Date
November 1, 2017
June 2, 2019
Enrollment:16
Age range:
18 Years ↔
any
Population:Cisgender Men, Cisgender Women