NCT03202992

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 Single and Multiple Doses of Topical ABI-1968 in Subjects With Anal High-Grade Squamous Intraepithelial Lesions (aHSIL)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (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 Neoplasms

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-08-11
• Primary completion: 2019-02-04
• Completion: 2019-02-04
• First posted: 2017-06-29
• Last updated: 2019-02-07

Locations

6 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study