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Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection

NCT03202992 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2019-02-07

No results posted yet for this study

Summary

This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal precancerous lesions in adults with and without human immunodeficiency virus (HIV) infection.

Conditions

  • HSIL, High-Grade Squamous Intraepithelial Lesions
  • Human Papilloma Virus Infection
  • HIV Infection
  • Anal Cancer
  • Anus Neoplasms

Interventions

DRUG

ABI-1968

Topical cream applied at Day 1 for the SAD portion and applied at Day 1, Day 8, Day 15, Day 22 and Day 29 for the MAD portion

Sponsors & Collaborators

  • Antiva Biosciences

    lead INDUSTRY

Principal Investigators

  • Clinical Operations · Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may use the contacts provided below.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
27 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-11
Primary Completion
2019-02-04
Completion
2019-02-04
FDA Drug
Yes

Countries

  • United States
  • Australia

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 NCT03202992 on ClinicalTrials.gov