ACTRN12616000674437已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single-Center, Multiple-Dose Study to Assess the Safety and Pharmacokinetics of ZYN002 Administered as a Transdermal Gel to Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
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
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Main Inclusion Criteria:
- •1. Healthy male or female adults, 18-55 years of age, inclusive, at the time of screening.
- •2. Judged by the investigator to be in generally good health at screening based upon the results of a medical history, physical examination, 12-lead ECG, and clinical laboratory test results. Laboratory results outside of the reference range, but acceptable, must be documented as not clinically significant (NCS) at the discretion of the investigator.
- •3. Subjects have a body mass index between 18-34 kg/m2.
- •4. Females of childbearing potential must have a negative pregnancy test at the Screening Visit and pre-dose on Day 1, Day 7 and Day 14.
- •5. Subject agrees to abide by all study restrictions and comply with all study procedures.
- •6. Subject must be adequately informed of the nature and risks of the study and give written informed consent prior to screening.
- •7. In the investigator’s opinion, the subject is reliable and is willing and able to comply with all protocol requirements and procedures.
排除标准
- •Main Exclusion Criteria:
- •Any of the following is considered criterion for exclusion:
- •1. Females who are pregnant, nursing or planning a pregnancy; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 21 days prior to the first dose of study medication and for 28 days after the last dose of study medication.
- •a. Standard acceptable methods include abstinence or the use of a highly effective method of contraception, including; hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, vasectomy, intrauterine device.
- •2. Use of tobacco/nicotine-containing products within one month of Screening Visit or during study.
- •3. Subjects using any prescription drugs except hormonal contraception or herbal supplements within four weeks prior to the Screening Visit or any OTC drugs/vitamins within 72 hours prior to first dose of study medication.
- •4. Use of cannabis or any CBD-containing product within 4 weeks of Screening Visit or during the study.
- •5. Positive result for the presence of Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibodies (HCV-Ab), or human immunodeficiency virus (HIV) antibodies.
- •6. Positive drug screen for ethanol, cocaine, Delta 9-tetrahydrocannabinol (THC), barbiturates, amphetamines, benzodiazepines, and opiates.
- •7. Any clinically significant condition or abnormal findings at the Screening Visit that would, in the opinion of the investigator, preclude study participation or interfere with the evaluation of the study treatment.
- •8. Any skin disease or condition, including eczema, psoriasis, melanoma, acne or contact dermatitis, scarring, imperfections, lesions, tattoos or discoloration that may affect treatment application, application site assessments, or affect absorption of the study drug.
- •9. Use of cosmetics on the shoulder/upper arms or thighs, during the study period.
- •10. History of significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any adhesives, compound, or chemical class related to ZYN002 or its excipients.
- •11. Has taken grapefruit products within the last four weeks or during the study.
- •12. History of treatment for, or evidence of alcohol or drug abuse within the past year or regular alcohol consumption exceeding an average of two units of alcohol per day until the End of Study Visit.
- •13. History or current diagnosis of a significant psychiatric disorder that would, in the opinion of the investigator, affect the subject’s ability to comply with the study requirements.
- •14. Has suspected or confirmed cardiovascular disease.
- •15. Participation in any investigational product or device study within 30 days prior to Screening Visit (except clinical study ZYN2-CL-01 or ZYN2-CL-02), or is scheduled to participate in an investigational device or another investigational drug study during the course of this study.
- •16. Patient has a history of actual suicide attempt in the last 5 years or more than one lifetime suicide attempt.
- •17. Patient responded yes” to Question 4 or 5 of C-SSRS during Screening.
- •18. Demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol.
研究者
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