Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection
NCT ID: NCT03239223
Last Updated: 2019-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2018-01-01
2018-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Dose 1 - Multiple Ascending Dose (MAD)
ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22
ABI-1968
Topical ABI-1968 Cream or Placebo with 4 doses administered up to 4 Cohorts
Dose 2 - Multiple Ascending Dose (MAD)
ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22
ABI-1968
Topical ABI-1968 Cream or Placebo with 4 doses administered up to 4 Cohorts
Interventions
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ABI-1968
Topical ABI-1968 Cream or Placebo with 4 doses administered up to 4 Cohorts
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
25 Years
50 Years
FEMALE
No
Sponsors
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Antiva Biosciences
INDUSTRY
Responsible Party
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Locations
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Research Center
Los Angeles, California, United States
Research Center
Lake Worth, Florida, United States
Research Center
Idaho Falls, Idaho, United States
Research Center
Chapel Hill, North Carolina, United States
Research Center
Winston-Salem, North Carolina, United States
Research Center
Norfolk, Virginia, United States
Research Center
Camperdown, New South Wales, Australia
Research Center
Darlinghurst, New South Wales, Australia
Research Center
South Brisbane, Queensland, Australia
Countries
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Other Identifiers
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ABI-1968-102
Identifier Type: -
Identifier Source: org_study_id
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