Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection.

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 25, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 15, 2018

Estimated Primary Completion Date

June 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety & Tolerability of ABI-1968 for the treatment of cHSIL[ Time Frame: 42 days ]

Number of Adverse Events related to treatment

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Systemic exposure to ABI-1968 Topical Cream following topical application to the cervix.[ Time Frame: 42 days ]
Plasma concentrations of ABI-1968 over time

Descriptive Information

Brief Title ^ICMJE

Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection.

Official Title ^ICMJE

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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

Study Arms

Experimental: Dose 1
Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22
Experimental: Dose 2
Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22
Experimental: Dose 3
New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22
Experimental: Dose 4
New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22
Experimental: Dose 5
New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

July 1, 2019

Estimated Primary Completion Date

June 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

Female

Ages

25 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

South Africa

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Antiva Biosciences

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

August 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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