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

Primary Purpose

HSIL of Cervix, HSIL, High Grade Squamous Intraepithelial Lesions, High-Grade Cervical Intraepithelial Neoplasia

Status
Completed
Phase
Phase 1
Locations
South Africa
Study Type
Interventional
Intervention
Topical ABI-1968
Sponsored by
Antiva Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HSIL of Cervix

Eligibility Criteria

25 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose 1

Dose 2

Dose 3

Dose 4

Dose 5

Arm Description

Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22

Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22

New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22

New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22

New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22

Outcomes

Primary Outcome Measures

Safety & Tolerability of ABI-1968 for the treatment of cHSIL
Number of Adverse Events related to treatment

Secondary Outcome Measures

Systemic exposure to ABI-1968 Topical Cream following topical application to the cervix.
Plasma concentrations of ABI-1968 over time

Full Information

First Posted
September 25, 2018
Last Updated
January 11, 2021
Sponsor
Antiva Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT03697226
Brief Title
Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection.
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 21, 2018 (Actual)
Primary Completion Date
May 26, 2020 (Actual)
Study Completion Date
June 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Antiva Biosciences

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose 1
Arm Type
Experimental
Arm Description
Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22
Arm Title
Dose 2
Arm Type
Experimental
Arm Description
Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22
Arm Title
Dose 3
Arm Type
Experimental
Arm Description
New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22
Arm Title
Dose 4
Arm Type
Experimental
Arm Description
New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22
Arm Title
Dose 5
Arm Type
Experimental
Arm Description
New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22
Intervention Type
Drug
Intervention Name(s)
Topical ABI-1968
Intervention Description
Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts
Primary Outcome Measure Information:
Title
Safety & Tolerability of ABI-1968 for the treatment of cHSIL
Description
Number of Adverse Events related to treatment
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Systemic exposure to ABI-1968 Topical Cream following topical application to the cervix.
Description
Plasma concentrations of ABI-1968 over time
Time Frame
42 days
Other Pre-specified Outcome Measures:
Title
Histopathology of areas with biopsy-proven disease
Description
Number of subjects with complete and or partial regression of cHSIL by Histopathology
Time Frame
42 days
Title
Changes in HPV viral load following multiple doses of ABI-1968 Topical Cream
Description
Changes from baseline in HPV viral load following multiple doses of ABI-1968 Topical Cream
Time Frame
42 days

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women, 25 to 50 years old. Biopsy-confirmed cervical HSIL that is p16+ within 60 days of enrollment (dosing) with no evidence of invasive cancer in any specimen. Colposcopy is satisfactory based on visualization of the entire squamo-columnar junction (SCJ). The borders of all lesions must be completely visible. The upper limit of the visible (usually aceto-white) lesion is within 3 quadrants or less at screening. Exclusion Criteria: Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females. HIV positive (tested at screening visit or within 3 months of screening visit). Resolution of visible CIN lesion prior to enrollment. ECC positive for glandular disease (adenocarcinoma in situ) or invasive cancer. History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of CIN, or hysterectomy.
Facility Information:
Facility Name
Research Center
City
Bloemfontein
State/Province
Free State Province
ZIP/Postal Code
9301
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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