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

• Sponsor: Antiva Biosciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03239223
• Collaborator: (none)
• Enrollment: 16
• Locations: 9
• Arms: 2
• Actual Duration (Months): 9.9
• Patients Per Site: 1.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical precancerous lesions in adult women.

Condition or Disease	Intervention/Treatment	Phase
HSIL; HSIL of Cervix; High-Grade Squamous Intraepithelial Lesions; High-grade Cervical Intraepithelial Neoplasia; Human Papilloma Virus; Cervical Cancer; Cervical Intraepithelial Neoplasia; Cervical Neoplasm; Cervical Dysplasia; CIN	Drug: ABI-1968	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Up to two ascending dose cohorts (8 subjects per cohort) may receive multiple doses in 2 ascending dose strengths of ABI-1968 Topical Cream. After completing the multiple ascending dose portion a Cohort Expansion group of 32 to 40 subjects will be initiated.Up to two ascending dose cohorts (8 subjects per cohort) may receive multiple doses in 2 ascending dose strengths of ABI-1968 Topical Cream. After completing the multiple ascending dose portion a Cohort Expansion group of 32 to 40 subjects will be initiated.
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomised, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of Topical ABI-1968 in Subjects With Cervical High Grade Squamous Intreaepithelial Lesions (cHSIL)
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Oct 30, 2018
• Actual Study Completion Date: Oct 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose 1 - Multiple Ascending Dose (MAD) ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22	Drug: ABI-1968; Topical ABI-1968 Cream or Placebo with 4 doses administered up to 4 Cohorts
Experimental: Dose 2 - Multiple Ascending Dose (MAD) ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22	Drug: ABI-1968; Topical ABI-1968 Cream or Placebo with 4 doses administered up to 4 Cohorts

Outcome Measures

Primary Outcome Measures

1. Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of cHSIL [85 Days]

   Number of participants with Adverse Events related to treatment to determine MTD

Secondary Outcome Measures

1. Systemic exposure to Topical ABI-1968 Cream following topical application to the cervix. [85 Days]

   Plasma concentrations of ABI-1968 over time to determine systemic exposure

2. Histopathology of areas with biopsy-proven disease following multiple doses of Topical ABI-1968 Cream. [85 Days]

   Number of subjects with complete and or partial regression of cHSIL by Colposcopy and histopathology to determine change and impact over 4 weekly doses

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Women, 25 to 50 years old.

• Cervical HSIL diagnosis made within 2 months of enrollment and confirmed with biopsy with no evidence of invasive cancer in any specimen and must be p16+.

• Able and willing to abstain from sexual intercourse for 48 hours prior to first dose and 2 days after each dose.

• Generally experiencing regular menstrual cycles, unless using long-acting reversible contraception that induces amenorrhea (e.g., Mirena IUD, Norplant).

Exclusion Criteria:

• Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females.

• History of cancer, except basal cell or squamous cell carcinoma of the skin.

• History of genital herpes with > 3 outbreaks per year, or active non-HPV vaginal infection.

• Plan to have excision or ablation of the lesion(s) within 3 months of enrollment.

• History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of CIN, or hysterectomy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Center	Los Angeles	California	United States	90036
2	Research Center	Lake Worth	Florida	United States	33461
3	Research Center	Idaho Falls	Idaho	United States	83404
4	Research Center	Chapel Hill	North Carolina	United States	27517
5	Research Center	Winston-Salem	North Carolina	United States	27101
6	Research Center	Norfolk	Virginia	United States	84304
7	Research Center	Camperdown	New South Wales	Australia	2050
8	Research Center	Darlinghurst	New South Wales	Australia	2010
9	Research Center	South Brisbane	Queensland	Australia	4101

Sponsors and Collaborators

• Antiva Biosciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Antiva Biosciences
• ClinicalTrials.gov Identifier: NCT03239223
• Other Study ID Numbers: ABI-1968-102
• First Posted: Aug 3, 2017
• Last Update Posted: Jul 10, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Uterine Cervical Neoplasms; Neoplasms; Carcinoma in Situ; Papilloma; Cervical Intraepithelial Neoplasia; Uterine Cervical Dysplasia

Study Results

No Results Posted as of Jul 10, 2019