Trials / Completed
CompletedNCT03697226
Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection.
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Antiva Biosciences · Industry
- Sex
- Female
- Age
- 25 Years – 50 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Topical ABI-1968 | Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts |
Timeline
- Start date
- 2018-12-21
- Primary completion
- 2020-05-26
- Completion
- 2020-06-12
- First posted
- 2018-10-05
- Last updated
- 2021-01-13
Locations
1 site across 1 country: South Africa
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03697226. Inclusion in this directory is not an endorsement.