MedTrace Logo

OB-002H Gel Administered Vaginally and Rectally in HIV-1 Seronegative Adults

NCT04791007 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-03-18

No results posted yet for this study

Summary

This is a monocentric phase I study in open-label and randomized, double-blind, placebo-controlled cohorts of HIV-1 seronegative adults to evaluate the safety, acceptability, and pharmacokinetic of OB-002H Gel administrated vaginally and rectally.

Conditions

  • HIV Prevention

Interventions

DRUG

OB-002

vaginal or rectal administration

DRUG

Placebo

vaginal or rectal administration

Sponsors & Collaborators

  • Scope International AG

    collaborator INDUSTRY

  • Orion Biotechnology Polska Sp. z o.o.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-05
Primary Completion
2020-04-06
Completion
2020-08-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Drugs

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 NCT04791007 on ClinicalTrials.gov