Part A: A Study of ABI-2280 Vaginal Tablet in Participants with Cervical Intraepithelial neoplasia
Part A: An Open-Label, Single and Multiple-Dose Study to Evaluate Safety, Tolerability and Efficacy of ABI-2280 Vaginal Tablet in Participants with biopsy-confirmed Cervical Squamous Intraepithelial neoplasia (with visible lesions)
Antiva Bioscience, Inc.
9 participants
Aug 10, 2022
Interventional
Conditions
Summary
The study is designed to assess the safety, tolerability, plasma concentration and efficacy of ABI-2280 Vaginal Tablet, self-administered to participants with intravaginal applicator Part A of the study is consists of 3 Cohorts (A1, A2 and A3) Each cohort will enroll 3 participants Total of approximately 9 participants will be enrolled. The study includes Screening, Baseline Visit, Safety follow-up visit.
Eligibility
Inclusion Criteria14
- Women, 25 to 55 years old.
- Participants with biopsy-confirmed CIN (with visible lesions) regardless of p16 positivity may be enrolled upon consultation with PI and medical Monitor. These participants will not be required to get large loop excision of the transformation zone (LLETZ) if not medically necessary, as determined by the PI in consultation with the Medical Monitor.
- No prior treatment for Cervical intraepithelial neoplasia (CIN).
- Generally, in good health with no clinically significant pulmonary, cardiac, gastro-enterologic, neurologic, renal, musculoskeletal, rheumatologic, metabolic, neoplastic, or endocrine disease.
- Willing to use abstinence during the week(s) of study medication administration. In addition, participants agree to take additional strict precautions throughout the study to prevent pregnancy. Under the guidance of the PI, they will be informed of reliable birth control methods to include oral contraceptives and long-acting reversible contraceptive methods. IUDs are acceptable but should be inserted at least 1 month prior to enrollment; however, the use of contraception methods such as a diaphragm, spermicide or Nuvaring® are not allowed.
- Agree to abstain from activities such as vaginal douching or insertion of any vaginal products other than the investigational product for at least 48 hours prior to enrollment through 7 days after last dose.
- Generally experiencing regular menstrual cycles (as judged by the PI), unless using long-acting reversible contraception that induces amenorrhea (e.g., Mirena IUD, Norplant).
- Able and willing to return to the clinic for all study procedures.
- Able and willing to provide informed consent.
- Colposcopy is satisfactory based on visualization of the entire squamocolumnar junction (SCJ). The borders of all lesions must be completely visible.
- If cytology or previous histology suggests the presence of glandular disease, willing to undergo endocervical curettage (ECC) to rule out adenocarcinoma in situ or invasive cancer.
- The upper limit of the visible (usually aceto-white) lesion is within 3 quadrants or less at screening.
- Willing to provide access to medical records consisting of HPV test results and pathology reports including p16 results.
- Able and willing to abstain from sexual intercourse for 48 hours prior to first dose and 48 hours after each dose.
Exclusion Criteria25
- Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females.
- Unwilling to use stringent methods of contraception (including barrier method, as well as another acceptable method) throughout the course of the study.
- History of cancer, except basal cell or squamous cell carcinoma of the skin.
- History of genital herpes with outbreak within prior 12 months.
- Have an active pelvic or non-HPV (Human papillomavirus) vaginal infection (e.g., that was detected by a positive urine screen for gonorrhea or chlamydial infection, bimanual exam consistent with pelvic inflammatory disease, positive bedside testing criteria for bacterial vaginosis, candida vaginitis or trichomonal vaginitis, etc).
- Current or recent abnormal vaginal discharge and /or abnormal vaginal bleeding.
- Had a therapeutic abortion or miscarriage less than 3 months prior.
- Any clinically significant immune suppressing condition.
- Any medical condition that, in the opinion of the Investigator, would result in increased risk of bleeding at biopsy.
- Participants with a significant acute condition or any other condition that in the opinion of the Investigator might interfere with the evaluation of the study objectives.
- Taking any of the following medications: corticosteroids (inhaled and topical corticosteroids are allowed), immunomodulatory treatments, any prescription that in the opinion of the Investigator could interfere with the interpretation of the results or over the counter (OTC) intravaginal preparation within 2 weeks of enrollment (Study Day 1).
- Hypersensitivity to any component of the product formulation excipients and/or other nucleoside analogues (such as cidofovir, etc.).
- Participation in any clinical study with an experimental medication or device within 30 days or 5 half-lives (whichever is longer) of enrollment (Study Day 1).
- Human immunodeficiency virus (HIV) positive (tested at screening visit or tested within 3 months of screening visit).
- Menses expected to start within 7 days of enrollment (Study Day 1).
- Vaccination (even 1 dose) with a prophylactic HPV vaccine (i.e. Gardasil®, Gardasil®-9 or Cervarix®) in the last 3 months.
- Vaccination with a therapeutic HPV vaccine.
- Biopsy performed more than 60 days prior to enrollment (dosing), unless approved by the Medical Monitor.
- CIN not amenable to adequate colposcopic evaluations.
- Women who, in the PI’s judgment, would be harmed by the delay in undergoing definitive treatment as a result of study participation and the ABI-2280 Vaginal Tablet dosing schedule.
- Resolution of CIN lesion(s) 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.
- Plan to have excision or ablation of the lesions, or to undergo LLETZ before the end of the study.
- Current alcohol or substance abuse as assessed by the PI.
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Interventions
Investigational Product (IP): ABI-2280 Vaginal Tablet Dosage Form: Tablet Method of Administration: self-administered using a vaginal tablet applicator Dose: 0.1 mg, 0.3 mg, 1.0 mg The study consists of three parts Part A (single dose followed by multiple dose): Cohort A1: 0.1 mg of single dose ABI-2280 Vaginal tablet on Day 1, Day 8, 10, 12 Cohort A2: 0.3 mg of single dose ABI-2280 Vaginal tablet on Day 1, Day 8, 10, 12 Cohort A3: 1.0 mg of single dose ABI-2280 Vaginal tablet on Day 1, Day 8, 10, 12 The dose of ABI-2280 Vaginal Tablet will be self-administered by participants in clinic under the supervision of Principal Investigator (PI) or qualified designee. For all cohorts in Part A, participants will be enrolled and will receive the first dose of study drug on Day 1. If the Investigator deems the safety and tolerability at the follow-up visit on Day 8 acceptable, participants will begin multiple dosing in that cohort. Doses for multiple doses for each participant will not exceed what the participant previously received as a single dose. Enrollment in Cohorts A2 and A3 shall proceed after the Safety Monitoring Committee (SMC) has reviewed the safety data from Day 8 from all three participants, and other available data, of the preceding cohort and has determined it is safe to proceed. The first dose will be self-administered in the clinic by the participant, with supervision by the Principal Investigator (PI) or qualified designee. The subsequent doses will be self-administered at home. Participant will complete Patient Diary to confirm self-administration at home. Each Cohort will enrol distinct group of the participants
Locations(2)
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ACTRN12622001065785