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Safety Study of Monoclonal Antibodies to Reduce the Vaginal Transmission of HSV and HIV

NCT02579083 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-11-14

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and pharmacokinetics of MB66, a monoclonal antibody film for vaginal application that is being developed to potentially reduce the transmission of herpes simplex virus (HSV) and human immunodeficiency virus (HIV).

Conditions

  • HIV
  • Herpes Simplex Infections

Interventions

DRUG

MB66

10 mg of HSV8-N and 10 mg of VRC01-N monoclonal antibodies per MB66 film

DRUG

Placebo Film

The placebo film is composed of the identical excipients as MB66 without the monoclonal antibodies.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Boston University

    collaborator OTHER

  • The Miriam Hospital

    collaborator OTHER

  • KBio Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02579083 on ClinicalTrials.gov