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

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ClinicalTrials.gov Identifier: NCT03239223
Recruitment Status : Active, not recruiting
First Posted : August 3, 2017
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Antiva Biosciences

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 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.
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 : January 1, 2018
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of cHSIL [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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



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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03239223


Locations
United States, California
Research Center
Los Angeles, California, United States, 90036
United States, Florida
Research Center
Lake Worth, Florida, United States, 33461
United States, Idaho
Research Center
Idaho Falls, Idaho, United States, 83404
United States, North Carolina
Research Center
Chapel Hill, North Carolina, United States, 27517
Research Center
Winston-Salem, North Carolina, United States, 27101
United States, Virginia
Research Center
Norfolk, Virginia, United States, 84304
Australia, Queensland
Research Center
South Brisbane, Queensland, Australia, 4101
Sponsors and Collaborators
Antiva Biosciences

Responsible Party: Antiva Biosciences
ClinicalTrials.gov Identifier: NCT03239223     History of Changes
Other Study ID Numbers: ABI-1968-102
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
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
Squamous Intraepithelial Lesions of the Cervix
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Precancerous Conditions