PER-047-22尚未招募1 期
AN OPEN-LABEL SINGLE AND MULTIPLE-DOSE STUDY TO EVALUATE SAFETY, TOLERABILITY AND EFFICACY OF ABI-2280 VAGINAL INSERT (PREVIOUSLY REFERRED TO AS ABI-2280 VAGINAL TABLET) IN PARTICIPANTS WITH CERVICAL SQUAMOUS INTRAEPITHELIAL LESIONS.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Women, 25 to 55 years old.
- •2. For Part A, 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 LLETZ if not medically necessary, as determined by the PI in consultation with the Medical Monitor
- •3. For Part B, biopsy-confirmed cervical HSIL that is p16+ (p16INK4a expressed) within 60 days of enrollment (dosing) with no evidence of invasive cancer in any specimen. If biopsy was performed =60 days before planned enrollment, participants must agree to have another biopsy performed at the Screening visit, unless approved by the Medical Monitor.
- •4. No prior treatment for CIN.
- •5. Generally, in good health with no clinically significant pulmonary, cardiac, gastro-enterologic, neurologic, renal, musculoskeletal, rheumatologic, metabolic, neoplastic, or endocrine disease
- •6. 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
- •7.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.
- •8. Generally experiencing regular menstrual cycles (as judged by the PI), unless using long-acting reversible contraception that induces amenorrhea (e.g., Mirena IUD, Norplant).
- •9. Able and willing to return to the clinic for all study procedures.
- •10. Able and willing to provide informed consent.
- •11. Colposcopy is satisfactory based on visualization of the entire squamocolumnar junction (SCJ). The borders of all lesions must be completely visible.
- •12. 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,
排除标准
- •10. 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
- •9. Any medical condition that, in the opinion of the Investigator, would result in increased risk of bleeding at biopsy
- •7. Had a therapeutic abortion or miscarriage less than 3 months prior.
- •8. Any clinically significant immune suppressing condition.
- •1. Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females.
- •2. Unwilling to use stringent methods of contraception (including barrier method, as well as another acceptable method) throughout the course of the study.
- •3. History of cancer, except basal cell or squamous cell carcinoma of the skin.
- •4. History of genital herpes with outbreak within prior 12 months
- •5. Have an active pelvic or non-HPV 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).
- •6. Current or recent abnormal vaginal discharge and /or abnormal vaginal bleeding
- •11. 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).
- •12. Hypersensitivity to any component of the product formulation excipients and/or other nucleoside analogues (such as cidofovir, etc.).
- •13. 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).
研究者
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