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

Phase 1

Terminated

• Conditions: HSIL, High-Grade Squamous Intraepithelial Lesions; Human Papilloma Virus Infection; HIV Infection; Anal Cancer; Anus Neoplasm
• Interventions: Drug: Topical ABI-1968 cream

• Registration Number: NCT03677960
• Lead Sponsor: Antiva Biosciences

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-18
• Study First Submitted QC: 2018-09-18
• Study First Posted: 2018-09-19
• Study Start: 2018-12-17
• Status Verified: 2019-04
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

1. Women who are pregnant, plan to become pregnant in the next 3 months, or lactating females.
2. Received topical treatment or ablative procedures for aHSIL in the 6 months prior to enrolment.
3. History of cancer involving the anogenital region, or history of other cancers that have not been fully resolved and free of symptoms in the past 5 years
4. History of genital herpes with > 3 outbreaks per year.
5. Plan to have excision or ablation of the lesion(s) within 3 months of enrolment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose 1 - Multiple Ascending Dose(MAD)	Topical ABI-1968 cream	Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic
Dose 2 - Multiple Ascending Dose(MAD)	Topical ABI-1968 cream	Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic
Dose 3 - Multiple Ascending Dose(MAD)	Topical ABI-1968 cream	Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL	MAD portion is 84 days	Number of participants with Adverse Events related to treatment

Secondary Outcome Measures

Name	Time	Method
Systemic exposure to ABI-1968 Topical Cream following topical application to the anal canal.	MAD portion is 84 days	Plasma concentrations of ABI-1968 over time

Trial Locations

Locations (1)

Research Center; 🇦🇺 Darlinghurst, Sydney, Australia