Brief Title
Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection.
Official Title
An Open-Label Multiple-Dose, Dose Escalation Study To Evaluate Safety, Tolerability and Pharmacokinetics of Topical ABI-1968 in Participants With Cervical High Grade Squamous Intraepithelial Lesions
Brief Summary
This study evaluates the use of ABI-1968, a topical cream, in the treatment of cervical
precancerous lesions in females without human immunodeficiency virus (HIV) infection.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Safety & Tolerability of ABI-1968 for the treatment of cHSIL
Secondary Outcome
Systemic exposure to ABI-1968 Topical Cream following topical application to the cervix.
Condition
HSIL of Cervix
Intervention
Topical ABI-1968
Study Arms / Comparison Groups
Dose 1
Description: Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
8
Start Date
December 21, 2018
Completion Date
June 12, 2020
Primary Completion Date
May 26, 2020
Eligibility Criteria
Inclusion Criteria:
1. Women, 25 to 50 years old.
2. Biopsy-confirmed cervical HSIL that is p16+ within 60 days of enrollment (dosing) with
no evidence of invasive cancer in any specimen.
3. Colposcopy is satisfactory based on visualization of the entire squamo-columnar
junction (SCJ). The borders of all lesions must be completely visible.
4. The upper limit of the visible (usually aceto-white) lesion is within 3 quadrants or
less at screening.
Exclusion Criteria:
1. Women who are pregnant, plan to become pregnant in the next 4 months, or lactating
females.
2. HIV positive (tested at screening visit or within 3 months of screening visit).
3. Resolution of visible CIN lesion prior to enrollment.
4. ECC positive for glandular disease (adenocarcinoma in situ) or invasive cancer.
5. History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of
CIN, or hysterectomy.
Gender
Female
Ages
25 Years - 50 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
South Africa
Location Countries
South Africa
Administrative Informations
NCT ID
NCT03697226
Organization ID
ABI-1968-103
Responsible Party
Sponsor
Study Sponsor
Antiva Biosciences
Study Sponsor
, ,
Verification Date
July 2019