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Trial record 1 of 2 for:    Antiva | United States
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Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection

This study is currently recruiting participants.
Verified November 2017 by Antiva Biosciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT03239223
First Posted: August 3, 2017
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Antiva Biosciences
  Purpose
This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical precancerous lesions in adult women.

Condition Intervention Phase
HSIL HSIL of Cervix High-Grade Squamous Intraepithelial Lesions High-grade Cervical Intraepithelial Neoplasia Human Papilloma Virus Cervical Cancer Cervical Intraepithelial Neoplasia Cervical Neoplasm Cervical Dysplasia CIN Drug: ABI-1968 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Up to two ascending dose cohorts (8 subjects per cohort) may receive multiple doses in 2 ascending dose strengths of ABI-1968 Topical Cream. After completing the multiple ascending dose portion a Cohort Expansion group of 32 to 40 subjects will be initiated.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of Topical ABI-1968 in Subjects With Cervical High Grade Squamous Intreaepithelial Lesions (cHSIL)

Resource links provided by NLM:


Further study details as provided by Antiva Biosciences:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of cHSIL [ Time Frame: 85 Days ]
    Number of participants with Adverse Events related to treatment to determine MTD


Secondary Outcome Measures:
  • Systemic exposure to Topical ABI-1968 Cream following topical application to the cervix. [ Time Frame: 85 Days ]
    Plasma concentrations of ABI-1968 over time to determine systemic exposure

  • Histopathology of areas with biopsy-proven disease following multiple doses of Topical ABI-1968 Cream. [ Time Frame: 85 Days ]
    Number of subjects with complete and or partial regression of cHSIL by Colposcopy and histopathology to determine change and impact over 4 weekly doses


Estimated Enrollment: 48
Actual Study Start Date: November 1, 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 1 - Multiple Ascending Dose (MAD)
ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22
Drug: ABI-1968
Topical ABI-1968 Cream or Placebo with 4 doses administered up to 4 Cohorts
Experimental: Dose 2 - Multiple Ascending Dose (MAD)
ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22
Drug: ABI-1968
Topical ABI-1968 Cream or Placebo with 4 doses administered up to 4 Cohorts

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women, 25 to 50 years old.
  • Cervical HSIL diagnosis made within 2 months of enrollment and confirmed with biopsy with no evidence of invasive cancer in any specimen and must be p16+.
  • Able and willing to abstain from sexual intercourse for 48 hours prior to first dose and 2 days after each dose.
  • Generally experiencing regular menstrual cycles, unless using long-acting reversible contraception that induces amenorrhea (e.g., Mirena IUD, Norplant).

Exclusion Criteria:

  • Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females.
  • History of cancer, except basal cell or squamous cell carcinoma of the skin.
  • History of genital herpes with > 3 outbreaks per year, or active non-HPV vaginal infection.
  • Plan to have excision or ablation of the lesion(s) within 3 months of enrollment.
  • History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of CIN, or hysterectomy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03239223


Contacts
Contact: Clinical Operations 650-822-1400 Clinical@antivabio.com

Locations
United States, Florida
Research Center Recruiting
Lake Worth, Florida, United States, 33461
Contact: Clinical Operations    650-822-1400    clinical@antivabio.com   
United States, Idaho
Research Center Recruiting
Idaho Falls, Idaho, United States, 83404
Contact: Clinical Operations    650-822-1400    clinical@antivabio.com   
United States, North Carolina
Research Center Not yet recruiting
Chapel Hill, North Carolina, United States, 27517
Contact: Clinical Operations    650-822-1400    Clinical@antivabio.com   
Research Center Not yet recruiting
Winston-Salem, North Carolina, United States, 27101
Contact: Clinical Operations    650-822-1400    Clinical@antivabio.com   
Sponsors and Collaborators
Antiva Biosciences
  More Information

Responsible Party: Antiva Biosciences
ClinicalTrials.gov Identifier: NCT03239223     History of Changes
Other Study ID Numbers: ABI-1968-102
First Submitted: August 1, 2017
First Posted: August 3, 2017
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Neoplasms
Carcinoma in Situ
Papilloma
Cervical Intraepithelial Neoplasia
Uterine Cervical Dysplasia
Squamous Intraepithelial Lesions of the Cervix
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Precancerous Conditions