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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03202992




Registration number
NCT03202992
Ethics application status
Date submitted
24/06/2017
Date registered
29/06/2017
Date last updated
7/02/2019

Titles & IDs
Public title
Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection
Scientific title
Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Topical ABI-1968 in Subjects With Anal High-Grade Squamous Intraepithelial Lesions (aHSIL)
Secondary ID [1] 0 0
ABI-1968-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HSIL, High-Grade Squamous Intraepithelial Lesions 0 0
Human Papilloma Virus Infection 0 0
HIV Infection 0 0
Anal Cancer 0 0
Anus Neoplasms 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Cancer 0 0 0 0
Bowel - Anal
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Cervical (cervix)
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABI-1968

Experimental: Dose 1 -Single Ascending Dose (SAD) - SAD Dose Level 1 of ABI-1968 topical cream applied on Day 1 of the study

Experimental: Dose 2 -Single Ascending Dose (SAD) - SAD Dose Level 2 of ABI-1968 topical cream applied on Day 1 of the study

Experimental: Dose 3 -Single Ascending Dose(SAD) - SAD Dose Level 3 of ABI-1968 topical cream applied on Day 1 of the study

Experimental: Dose 4 -Single Ascending Dose(SAD) - SAD Dose Level 4 of ABI-1968 topical cream applied on Day 1 of the study

Experimental: Dose 5 -Single Ascending Dose(SAD) - SAD Dose Level 5 of ABI-1968 topical cream applied on Day 1 of the study

Experimental: Dose 1 - Multiple Ascending Dose(MAD) - MAD Dose Level 1 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29

Experimental: Dose 2 -Multiple Ascending Dose(MAD) - MAD Dose Level 2 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29

Experimental: Dose 3 -Multiple Ascending Dose(MAD) - MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29

Experimental: Multiple Ascending Dose (MAD) Cohort Expansion - MAD Cohort Expansion of ABI-1968 applied at Day 1, Day 8, Day 15, Day 22 and Day 29

Experimental: Dose 4-Multiple Ascending Dose(MAD) - MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29


Treatment: Drugs: ABI-1968
Topical cream applied at Day 1 for the SAD portion and applied at Day 1, Day 8, Day 15, Day 22 and Day 29 for the MAD portion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL
Timepoint [1] 0 0
SAD portion is 29 days/MAD portion is 84 days
Secondary outcome [1] 0 0
Systemic exposure to ABI-1968 Topical Cream following topical application to the anal canal.
Timepoint [1] 0 0
SAD portion is 29 days/MAD portion is 84 days
Secondary outcome [2] 0 0
Histopathology of areas with biopsy-proven disease following single and multiple doses of ABI-1968 Topical Cream.
Timepoint [2] 0 0
SAD portion is 29 days/MAD portion is 84 days

Eligibility
Key inclusion criteria
1. Female or male subjects, at least 27 years old.

2. Confirmed diagnosis of intra-anal HSIL at least 3 months prior to screening and
confirmed by histopathology (with p16 positive staining)

3. Intra-anal HSIL are visible and evaluable by HRA at the time of screening, and no
lesion(s) is suspicious for invasive cancer.

4. For HIV-positive subjects, CD4 count must be at least 200/mm3 with undetectable (<50
copies/mL) viral load within the 3 months prior to enrollment. Subjects must be on a
stable regimen of antiretroviral drugs for the 3 months prior to enrollment.
Minimum age
27 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women who are pregnant, plan to become pregnant in the next 3 months, or lactating
females.

2. Received topical treatment or ablative procedures for aHSIL in the 6 months prior to
enrolment.

3. History of cancer, including anal cancer (with the exception of basal cell or squamous
cell carcinoma of the skin), or currently undergoing treatment for any skin cancer.

4. History of genital herpes with > 3 outbreaks per year.

5. Plan to have excision or ablation of the lesion(s) within 3 months of enrolment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/02/2019
Sample size
Target
Accrual to date
Final
57
Recruitment in Australia
Recruitment state(s)
Darlinghurs
Recruitment hospital [1] 0 0
Research Center - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Antiva Biosciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal
precancerous lesions in adults with and without human immunodeficiency virus (HIV) infection.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03202992
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Operations
Address 0 0
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Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03202992