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

NCT03239223 — Phase 1, Completed, 16 participants, Antiva Biosciences

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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)

Registry	NCT03239223
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, sequential, masking: triple, treatment
Enrollment	16 (Actual)
Sponsor	Antiva Biosciences (Industry)
Conditions	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
Interventions	ABI-1968 (Drug)
Dates	start 2018-01-01, primary completion 2018-10-30, completion 2018-10-30, first posted 2017-08-03, last updated 2019-07-10
Locations	9 sites in United States, Australia

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
Dose 1 - Multiple Ascending Dose (MAD)	Experimental	Drug: 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)	Experimental	Drug: ABI-1968	ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22

ABI-1968 (Drug): Topical ABI-1968 Cream or Placebo with 4 doses administered up to 4 Cohorts

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: Female, ages: 25 Years to 50 Years

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.

+Locations (9)

Facility	City	Country
Research Center	Los Angeles, California	United States
Research Center	Lake Worth, Florida	United States
Research Center	Idaho Falls, Idaho	United States
Research Center	Chapel Hill, North Carolina	United States
Research Center	Winston-Salem, North Carolina	United States
Research Center	Norfolk, Virginia	United States
Research Center	Camperdown, New South Wales	Australia
Research Center	Darlinghurst, New South Wales	Australia
Research Center	South Brisbane, Queensland	Australia