NCT03677960

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

Open-Label Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Multiple Doses Of Topical Abi-1968 In Subjects With Anal High-Grade Squamous Intraepithelial Lesions (aHSIL)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Antiva Biosciences · Industry
• Sex: All
• Age: 27 Years
• Healthy volunteers: Not accepted

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 Neoplasm

Interventions

Type	Name	Description
DRUG	Topical ABI-1968 cream	Multiple doses of Topical ABI-1968 Cream administered by the Investigator in the clinic up to Day 29

Timeline

• Start date: 2018-12-17
• Primary completion: 2019-06-30
• Completion: 2019-06-30
• First posted: 2018-09-19
• Last updated: 2019-07-24

Locations

2 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study