ImQuest (IQP) DuoGel Phase 1 Pharmacokinetic Study

Phase 1 Completed 10 enrolled Johns Hopkins University ImQuest Pharmaceuticals, Inc. · collab National Institute of Allergy and Infectious Diseases (NIAID) · collab

NaSingle-groupOpen-labelOther

Summary

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.

Timeline

Start: 2017-11-01
Primary completion: 2019-05-30
Completion: 2019-06-02

Publications

Al-Khouja A, Shieh E, Fuchs EJ, Marzinke MA, Bakshi RP, Hummert P, Ham AS, Buckheit KW, Breakey J, Weld ED, Chen H, Caffo BS, Buckheit RW, Hendrix CW. Examining the Safety, Pharmacokinetics, and Pharmacodynamics of a Rectally Administered IQP-0528 Gel for HIV Pre-Exposure Prophylaxis: A First-In-Human Study. AIDS Res Hum Retroviruses. 2021 Jun;37(6):444-452. doi: 10.1089/AID.2020.0188. Epub 2021 Jan 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	IQP-0528	Unknown	1 %	Rectal
Subject	IQP-0528	Unknown	10 ml	Rectal

Indications

No indication recorded.