ACTRN12618001993280招募中1 期
An Exploratory Clinical Study to Evaluate the safety and Skin Tolerability of Multiple Formulations of Once Weekly Investigational Transdermal Delivery System in Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 30 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. Healthy, adult, Caucasian females and males aged 30 to 65 years (inclusive) on the day of randomization. Enrollment will aim for 100 percent females; however, up to 25 percent males may be enrolled per the Sponsor’s approval
- •2. Has a body mass index between 18-32 kg/m^2 (inclusive).
- •3. Have a Fitzpatrick skin type of I, II, or III
- •4. Must be willing and able to understand and comply with the scheduled study visits, treatment plans, laboratory tests, and other procedures by providing a signed and dated written informed consent prior to the initiation of any study procedures.
- •5. Women of child-bearing potential and men should be sexually inactive (abstinent). Abstinence, defined as complete avoidance of heterosexual intercourse, is an acceptable form of contraception.
- •6. Willing and able to discontinue all non-steroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) NSAID analgesic therapy, 30 days prior to Day 1 and until completion of the Study Exit Visit.
- •7. If the subject is receiving allowed medications for the treatment of non-excluded medical conditions, the dose must be stable for at least 28 days before randomization on Day 1.
排除标准
- •1. Participation in another clinical study with an IP or device within 30 days or 5 half-lives, whichever is longer, prior to screening.
- •2. Plasma donation within 28 days of screening or any blood donation or blood loss greater than 500 mL within 3 months of screening.
- •3. Has skin color that may not allow reliable evaluation of irritation.
- •4. Female subjects with a positive pregnancy test or lactating.
- •5. Has intolerance to venipuncture and/or inability to comply with the blood sampling required for this study.
- •6. Has cuts, scratches/abrasions, scars, breaks in the skin surface, recent tattoos (within the last 6 months) at the application site, skin with excessive hair, indications of sunburn, excessive skin tanning, stretch marks and/or similar abnormalities at the intended application sites
- •7. Unwilling to refrain from using tanning salons, saunas, or from sunbathing during the course of the study. Unwilling to avoid shaving of the application site, waxing of the application site, or using lotion hair remover on or near application site from 48 hours before patch application and during the conduct of the study.
- •8. Has a history of or is currently consuming high caffeine levels
- •9. Smokes more than 20 cigarettes per day
- •10. Presence of any major psychiatric disorder
- •11. Significant cardiovascular disease
- •12. Significant or chronic lung disease
- •13. Diabetes complicated
- •14. Known or suspected systemic infection
- •15. History of severe allergy/hypersensitivity reactions
- •16. History of cancer
- •17. Transient ischemic attack or stroke in the last 3 years.
- •18. Myocardial infarction, hospitalization for unstable angina or arrhythmia or unexplained syncope
- •19. Clinically important infection
- •20. Any medical or surgical procedure or trauma within 28 days
- •21. Current serious or unstable clinically important illness
- •22. Has a history of allergic reactions to medical grade adhesive tapes, sunscreens, cosmetics, lotions, fragrances, or latex.
- •23. Use of adjuvant analgesics
- •24. Use of muscle relaxants
- •25. Use of any topical medication in the areas intended for patch application
- •26. Use of any topical products without medicinal ingredient (including but not limited to perfumes, body lotions, sunscreens, spray or patch oils, creams and alcohol) on the area intended for patch application within 48 hours prior to the first patch application
- •27. Prior or current use of fingolimod hydrochloride, memantine hydrochloride, or to piperidine derivatives and related drugs.
- •28. Clinically important abnormality
- •29. Heart rate less than or equal to 60 bpm.
- •30. Clinically significant hypertension
- •31. Any clinically significant abnormality in electrocardiogram (ECG) rhythm
- •32. A positive pregnancy test at screening
研究者
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