Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection.
NCT03697226 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2021-01-13
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.
Conditions
- HSIL of Cervix
- HSIL, High Grade Squamous Intraepithelial Lesions
- High-Grade Cervical Intraepithelial Neoplasia
- Human Papilloma Virus
- HIV Negative
- Cervical Cancer
- CIN - Cervical Intraepithelial Neoplasia
- Cervical Neoplasm
- Cervical Dysplasia
Interventions
- DRUG
-
Topical ABI-1968
Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts
Sponsors & Collaborators
-
Antiva Biosciences
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 25 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-12-21
- Primary Completion
- 2020-05-26
- Completion
- 2020-06-12
- FDA Drug
- Yes
Countries
- South Africa
Study Locations
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