Back to resultsStudy of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection
Primary Purpose
HSIL, HSIL of Cervix, High-Grade Squamous Intraepithelial Lesions
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ABI-1968
Sponsored by
About this trial
This is an interventional treatment trial for HSIL
Eligibility 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.
Sites / Locations
- Research Center
- Research Center
- Research Center
- Research Center
- Research Center
- Research Center
- Research Center
- Research Center
- Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dose 1 - Multiple Ascending Dose (MAD)
Dose 2 - Multiple Ascending Dose (MAD)
Arm Description
ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22
ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of cHSIL
Number of participants with Adverse Events related to treatment to determine MTD
Secondary Outcome Measures
Systemic exposure to Topical ABI-1968 Cream following topical application to the cervix.
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.
Number of subjects with complete and or partial regression of cHSIL by Colposcopy and histopathology to determine change and impact over 4 weekly doses
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03239223
Brief Title
Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Antiva Biosciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical precancerous lesions in adult women.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose 1 - Multiple Ascending Dose (MAD)
Arm Type
Experimental
Arm Description
ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22
Arm Title
Dose 2 - Multiple Ascending Dose (MAD)
Arm Type
Experimental
Arm Description
ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22
Intervention Type
Drug
Intervention Name(s)
ABI-1968
Intervention Description
Topical ABI-1968 Cream or Placebo with 4 doses administered up to 4 Cohorts
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of cHSIL
Description
Number of participants with Adverse Events related to treatment to determine MTD
Time Frame
85 Days
Secondary Outcome Measure Information:
Title
Systemic exposure to Topical ABI-1968 Cream following topical application to the cervix.
Description
Plasma concentrations of ABI-1968 over time to determine systemic exposure
Time Frame
85 Days
Title
Histopathology of areas with biopsy-proven disease following multiple doses of Topical ABI-1968 Cream.
Description
Number of subjects with complete and or partial regression of cHSIL by Colposcopy and histopathology to determine change and impact over 4 weekly doses
Time Frame
85 Days
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Research Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Research Center
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Research Center
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Research Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
Research Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Facility Name
Research Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
84304
Country
United States
Facility Name
Research Center
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Research Center
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Research Center
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection
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