A Phase 1 interventional study of Topical ABI-1968 in HSIL of Cervix, HSIL, High Grade Squamous Intraepithelial Lesions and High-Grade Cervical Intraepithelial Neoplasia, sponsored by Antiva Biosciences. Completed at 1 site in South Africa. Open to female participants aged 25 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-01-13.
Sponsored by Antiva Biosciences · Phase 1, Interventional, and Treatment
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.
1,883 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's enrollment of 8 is below the median of 100 across 1,378 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Antiva Biosciences is the lead sponsor of 6 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22
Drug: Topical ABI-1968
Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22
Drug: Topical ABI-1968
New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22
Drug: Topical ABI-1968
New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22
Drug: Topical ABI-1968
New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22
Drug: Topical ABI-1968
Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts
Safety & Tolerability of ABI-1968 for the treatment of cHSIL
Number of Adverse Events related to treatment
Time frame: 42 days
Systemic exposure to ABI-1968 Topical Cream following topical application to the cervix.
Plasma concentrations of ABI-1968 over time
Time frame: 42 days
Histopathology of areas with biopsy-proven disease
Number of subjects with complete and or partial regression of cHSIL by Histopathology
Time frame: 42 days
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
Time frame: 42 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Antiva Biosciences