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

Phase 1

Completed

• Conditions: High-Grade Squamous Intraepithelial Lesions; Human Papilloma Virus; Cervical Cancer; Cervical Intraepithelial Neoplasia; Cervical Neoplasm; Cervical Dysplasia; CIN; HSIL; HSIL of Cervix; High-grade Cervical Intraepithelial Neoplasia
• Interventions: Drug: ABI-1968

• Registration Number: NCT03239223
• Lead Sponsor: Antiva Biosciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-01
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-03
• Study Start: 2018-01-01
• Primary Completion: 2018-10-30
• Study Completion: 2018-10-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-08
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose 1 - Multiple Ascending Dose (MAD)	ABI-1968	ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22
Dose 2 - Multiple Ascending Dose (MAD)	ABI-1968	ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Research Center; 🇦🇺 South Brisbane, Queensland, Australia