A Study to Evaluate Topical ABI-1968 Cervical Tissue Penetration in Subjects Prior to Hysterectomy Performed for Benign Indications
A study to evaluate topical ABI-1968 cervical tissue penetration after multiple weekly topical ABI-1968 administration intravaginally in subjects prior to hysterectomy performed for benign indications.
Antiva Bioscience, Inc.
15 participants
Oct 22, 2019
Interventional
Conditions
Summary
The study is designed to assess cervical tissue penetration of Topical ABI-1968 Gel after multiple weekly dosing in participants with and without cervical cap. Participants who meet all inclusion and none of the exclusion criteria will be evaluated throughout the study. Up to 12 participants may be enrolled into one of the following four groups (3 participants per group). • Group 1: Four weekly dosing of up to 1% of Topical ABI-1968 Gel with cervical cap • Group 2: Four weekly dosing of up to 1% of Topical ABI-1968 Gel without cervical cap • Group 3: Up to 4 weekly dosing up to 1% of Topical ABI-1968 Gel (with or without cervical cap) • Optional Group 4: Repeat the same dosing regimen used in previous groups or test a different regimen (but not to exceed a dose up to 1% Topical ABI-1968 Gel and no more than four weekly dosing). • Group 5: Up to 4 weekly dosing just 1% gel of topical ABI-cream with a cervical cap.
Eligibility
Inclusion Criteria11
- Women between the ages of 30 and 55 years, who are premenopausal, with an intact uterus.
- Generally, in good health with no clinically significant pulmonary, cardiac, gastroenterologic,
- neurologic, renal, musculoskeletal, rheumatologic, metabolic, neoplastic, or
- endocrine disease.
- Scheduled for a hysterectomy for benign indications (e.g. fibroids, dysfunctional uterine
- bleeding, urinary incontinence, pelvic pain etc).
- Agree to abstain from activities such as sexual intercourse, vaginal douching or insertion of
- any vaginal products other than the study drug for at least 48 hours after each dose and to
- minimize partner exposure to Topical ABI-1968 Gel during study participation.
- Able and willing to return to the clinic for all study procedures.
- Able and willing to provide informed consent.
Exclusion Criteria23
- Women who are pregnant
- Women who are post-menopausal
- History of cancer, except basal cell or squamous cell carcinoma of the skin.
- Have a diagnosis of a gynecological cancer or suspicion of cancer that leads to the
- hysterectomy
- History of abnormal cervical cytology within the past 12 months
- History of excisional (e.g. LEEP, LLETZ) or ablative (e.g. cryo- or electrocautery, laser)
- treatment to the cervix
- History of genital herpes with greater than 3 outbreaks per year, or active non-HPV vaginal infection.
- Have an active pelvic infection (positive urine screen for gonorrhea or chlamydial infection,
- positive bedside testing criteria for bacterial vaginosis, candida vaginitis or trichomonal
- vaginitis, positive bimanual exam consistent with pelvic inflammatory disease).
- Any clinically significant immune suppressing condition.
- 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.
- Currently taking any of the following medications: over the counter (OTC) intra-vaginal
- preparation, or any prescription that in the opinion of the Investigator could interfere with the
- interpretation of the results, within 2 weeks of enrollment.
- Hypersensitivity to any component of 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.
- Menses expected to start within 7 days of enrollment.
- Current alcohol or substance abuse as assessed by the Principal Investigator.
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Interventions
The study is designed to assess cervical tissue penetration of Topical ABI-1968 Gel after multiple weekly dosing in participants with and without cervical cap. Participants who are scheduled to undergo hysterectomy for benign indication in approximately 4 weeks will be enrolled. Up to 12 participants may be enrolled into one of four groups (3 participants per group). Topical ABI-1968 Gel will be administered intra-vaginally by the Investigator or designee after visualizing the cervix in the dorsal lithotomy position. A single-use graduated applicator will be provided for administration of an approximately 2 g dose at a strength up to1%. Eligible participants will receive study gel once weekly up to 4 doses administered by the clinician or designee in the clinic prior to the participant’s planned hysterectomy. One of two methods of delivery of the study gel to the cervix may be used: 1) Just 1% gel gel applied by the clinician directly to the cervix after visualization or 2) Just 1% gel gel Topical ABI-1968 Gel applied into the dome of a cervical cap or diaphragm and inserted blindly into the vagina by the clinician to cover the cervix. Duration of treatment: Once weekly dosing up to a 4-week treatment period. Based on safety data from an ongoing study it has been decided that all groups in Study ABI-1968-104 will receive 1.0% Topical ABI-1968 Gel for each dose. Participants will be assigned to a dosing group by the Sponsor after a consultation with the Investigator. Exact number of doses is determined in each participant by Four weekly dosing in groups 1 and 2 and up to 4 in group 3. Group 3 is for participants whose hysterectomy is scheduled such that they are unable to fit in a total of 4 weekly doses. Group 1: Four weekly dosing of up to 1% of Topical ABI-1968 Gel with cervical cap • Group 2: Four weekly dosing of up to 1% of Topical ABI-1968 Gel without cervical cap • Group 3: Up to 4 weekly dosing up to 1% of Topical ABI-1968 Gel (with or without cervical cap) • Optional Group 4: Repeat the same dosing regimen used in previous groups or test a different regimen (but not to exceed a dose up to 1% Topical ABI-1968 Gel and no more than four weekly dosing). • Group 5: Up to 4 weekly dosing just 1% gel of topical ABI-cream with a cervical cap. Group 4 was incorporated to allow Sponsor to add additional participants should there be a need to further explore any finding from one of the other groups. Sponsor will review initial results and then consult with PIs as to whether there is a need to explore any group further Treatment will be the same as one of the existing 3 groups. Which ever needs further investigation.
Locations(2)
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ACTRN12619001554156