ACTRN12621001702808已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Clofazimine Inhalation Suspension (MNKD-101) in Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
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
- •1. Body Mass Index (BMI) between 18.0 and 32.0 kg/m2 (inclusive). Body weight must be greater than 50 kg.
- •2. Participants whose smoking habit in the 12 months prior to Screening included no more than 2 cigarettes or equivalent dose per week (includes e-cigarettes and other nicotine and tobacco products) can be included in the study but must be willing to abstain from smoking for one month prior to admission to the Clinical research unit (CRU) and while resident at the CRU. Thorough documentation of smoking habits is required.
- •3. Negative test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), and Human Immunodeficiency Virus (HIV) antibody at Screening.
- •4. Female participants must be of non-childbearing potential, as follows:
- •a. At least 1 year postmenopausal (amenorrhea more than 12 months in the absence of an alternative medical cause and Follicle-stimulating hormone (FSH) greater than 40 IU/mL in women not using hormonal contraception or hormonal replacement therapy) prior to Screening.
- •b. Surgically sterile (bilateral oophorectomy, hysterectomy, bilateral salpingectomy, or bilateral tubal ligation).
- •5. To protect partners from possible exposure to study medication in semen, male participants must use a condom during the study, even if they have had a vasectomy or their partner is not of childbearing potential. Males will be required to continue to use condoms for 90 days after the last dose of MNKD-101.
- •If engaged in sexual relations with a woman of childbearing potential (WOCBP), his partner must be surgically sterile (eg, tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or using an acceptable, highly effective contraceptive method from Screening until at least 135 days have passed since IP administration. Note: medically acceptable methods of contraception that may be used by the partner include combined oral contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine device, and etonogestrel implant.
- •Males must not donate sperm for at least 135 days after the last dose of MNKD-101.
排除标准
- •1. Clinically relevant abnormal history, physical findings, Electrocardiogram (ECG), or clinical laboratory values at the Screening assessment or Day 1 that could interfere with the objectives of the study or the safety of the participant.
- •2. Presence or history of acute or chronic illness sufficient to invalidate the participant’s participation in the study or make it unnecessarily hazardous.
- •3. A condition that, in the opinion of the Investigator, could compromise the wellbeing of the participant or course of the study, or prevent the participant from meeting or performing any study requirements.
- •4. Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, cancer, or history of any psychotic mental illness.
- •5. A score on the Columbia Suicide Severity Rating Scale (C-SSRS) consistent with suicidal ideation or behavior.
- •6. History of asthma, with the exception of resolved childhood asthma.
研究者
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