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ImQuest (IQP) DuoGel Phase 1 Pharmacokinetic Study

NCT03082690 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-10-14

No results posted yet for this study

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.

Conditions

  • HIV Prevention

Interventions

DRUG

DuoGel

1% IQP-0528 in gel formulation

Sponsors & Collaborators

  • ImQuest Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Craig Hendrix, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2019-05-30
Completion
2019-06-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03082690 on ClinicalTrials.gov