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

NCT03202992 — Phase 1, Completed, 57 participants, Antiva Biosciences

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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)

Registry	NCT03202992
Status	Completed
Phase	Phase 1
Study type	Interventional; non randomized, sequential, masking: none, treatment
Enrollment	57 (Actual)
Sponsor	Antiva Biosciences (Industry)
Conditions	HSIL, High-Grade Squamous Intraepithelial Lesions, Human Papilloma Virus Infection, HIV Infection, Anal Cancer, Anus Neoplasms
Interventions	ABI-1968 (Drug)
Dates	start 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 in United States, Australia

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Dose 1 -Single Ascending Dose (SAD)	Experimental	Drug: ABI-1968	SAD Dose Level 1 of ABI-1968 topical cream applied on Day 1 of the study
Dose 2 -Single Ascending Dose (SAD)	Experimental	Drug: ABI-1968	SAD Dose Level 2 of ABI-1968 topical cream applied on Day 1 of the study
Dose 3 -Single Ascending Dose(SAD)	Experimental	Drug: ABI-1968	SAD Dose Level 3 of ABI-1968 topical cream applied on Day 1 of the study
Dose 4 -Single Ascending Dose(SAD)	Experimental	Drug: ABI-1968	SAD Dose Level 4 of ABI-1968 topical cream applied on Day 1 of the study
Dose 5 -Single Ascending Dose(SAD)	Experimental	Drug: ABI-1968	SAD Dose Level 5 of ABI-1968 topical cream applied on Day 1 of the study
Dose 1 - Multiple Ascending Dose(MAD)	Experimental	Drug: ABI-1968	MAD Dose Level 1 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29
Dose 2 -Multiple Ascending Dose(MAD)	Experimental	Drug: ABI-1968	MAD Dose Level 2 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29
Dose 3 -Multiple Ascending Dose(MAD)	Experimental	Drug: ABI-1968	MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29
Multiple Ascending Dose (MAD) Cohort Expansion	Experimental	Drug: ABI-1968	MAD Cohort Expansion of ABI-1968 applied at Day 1, Day 8, Day 15, Day 22 and Day 29
Dose 4-Multiple Ascending Dose(MAD)	Experimental	Drug: ABI-1968	MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29

ABI-1968 (Drug): 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

+Outcome measures

Primary outcomes

Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL [SAD portion is 29 days/MAD portion is 84 days]: Number of participants with Adverse Events related to treatment

Secondary outcomes

Systemic exposure to ABI-1968 Topical Cream following topical application to the anal canal. [SAD portion is 29 days/MAD portion is 84 days]: Plasma concentrations of ABI-1968 over time
Histopathology of areas with biopsy-proven disease following single and multiple doses of ABI-1968 Topical Cream. [SAD portion is 29 days/MAD portion is 84 days]: Number of subjects with complete and or partial regression of aHSIL by High Resolution Anoscopy (HRA) and histopathology

+Eligibility

Sex: All, ages: 27 Years to any

Inclusion Criteria:

1. Female or male subjects, at least 27 years old.
2. Confirmed diagnosis of intra-anal HSIL at least 3 months prior to screening and confirmed by histopathology (with p16 positive staining)
3. Intra-anal HSIL are visible and evaluable by HRA at the time of screening, and no lesion(s) is suspicious for invasive cancer.
4. For HIV-positive subjects, CD4 count must be at least 200/mm3 with undetectable (<50 copies/mL) viral load within the 3 months prior to enrollment. Subjects must be on a stable regimen of antiretroviral drugs for the 3 months prior to enrollment.

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, including anal cancer (with the exception of basal cell or squamous cell carcinoma of the skin), or currently undergoing treatment for any skin cancer.
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.

+Locations (6)

Facility	City	Country
Research Center	San Francisco, California	United States
Research Center	Orlando, Florida	United States
Research Center	Chicago, Illinois	United States
Research Center	New York, New York	United States
Research Center	Winston-Salem, North Carolina	United States
Research Center	Sydney, Darlinghurst	Australia

+Investigators

Clinical Operations, Study chair, 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.

My Notes

Public

To Read Reading Read