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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03697226
Other study ID # ABI-1968-103
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 21, 2018
Est. completion date June 12, 2020

Study information

Verified date July 2019
Source Antiva Biosciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date June 12, 2020
Est. primary completion date May 26, 2020
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 50 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Topical ABI-1968
Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts

Locations

Country Name City State
South Africa Research Center Bloemfontein Free State Province

Sponsors (1)

Lead Sponsor Collaborator
Antiva Biosciences

Country where clinical trial is conducted

South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Other Histopathology of areas with biopsy-proven disease Number of subjects with complete and or partial regression of cHSIL by Histopathology 42 days
Other Changes in HPV viral load following multiple doses of ABI-1968 Topical Cream Changes from baseline in HPV viral load following multiple doses of ABI-1968 Topical Cream 42 days
Primary Safety & Tolerability of ABI-1968 for the treatment of cHSIL Number of Adverse Events related to treatment 42 days
Secondary Systemic exposure to ABI-1968 Topical Cream following topical application to the cervix. Plasma concentrations of ABI-1968 over time 42 days
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