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Trial record 1 of 1 for:    ABI-1968-102
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Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03239223
Recruitment Status : Completed
First Posted : August 3, 2017
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Antiva Biosciences

Tracking Information
First Submitted Date  ICMJE August 1, 2017
First Posted Date  ICMJE August 3, 2017
Last Update Posted Date July 10, 2019
Actual Study Start Date  ICMJE January 1, 2018
Actual Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection
Official Title  ICMJE 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)
Brief Summary This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical precancerous lesions in adult women.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • 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
Intervention  ICMJE Drug: ABI-1968
Topical ABI-1968 Cream or Placebo with 4 doses administered up to 4 Cohorts
Study Arms  ICMJE
  • Experimental: Dose 1 - Multiple Ascending Dose (MAD)
    ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22
    Intervention: Drug: ABI-1968
  • Experimental: Dose 2 - Multiple Ascending Dose (MAD)
    ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22
    Intervention: Drug: ABI-1968
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 15, 2018)
16
Original Estimated Enrollment  ICMJE
 (submitted: August 2, 2017)
48
Actual Study Completion Date  ICMJE October 30, 2018
Actual Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 25 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03239223
Other Study ID Numbers  ICMJE ABI-1968-102
Has Data Monitoring Committee Yes
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  ICMJE
Plan to Share IPD: No
Responsible Party Antiva Biosciences
Study Sponsor  ICMJE Antiva Biosciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Antiva Biosciences
Verification Date July 2019

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