ACTRN12621000160831已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of GRX-917 in Healthy Adult Subjects
Gaba Therapeutics Australia Pty Ltd a subsidiary of Gaba Therapeutics, Inc0 个研究点目标入组 102 人开始时间: 2021年2月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
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. Aged between 18 and 55 years of age at time of consent
- •2. Male or female and meet the following conditions:
- •a. Female participants must be of non-childbearing potential, or,
- •b. If of childbearing potential, be non-pregnant or lactating and agree to use highly effective contraception from screening through 30 days post- dose. Hormonal forms of contraception are contraindicated in this study.
- •c. Male participants, if engaging in sexual intercourse with a female partner of childbearing potential, must be willing to use highly effective contraception from screening through 90 days post-dose and agree not to donate sperm during this period.
- •3. Is judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests performed at the screening visit and/or before the first dose of study drug.
- •4. Weigh at least 50 kg at the time of screening
- •5. Have a body mass index (BMI) between 18.0 and 32.0 kg/m2 at the time of screening
- •6. Negative SARS-CoV2 test on Day -2 per site standards
- •7. Agrees to be available for all study visits and cooperate fully with the requirements of the study protocol, including the schedule of assessments
- •8. Willing to refrain from will refrain from any systemic or topical medication, including herbal supplements taken within 6 times the elimination half-life of the medication or within 14 days of the first dose administration, whichever is longer.
- •9. Willing and able to refrain from consuming any strong inhibitors or inducers of CYP3A4 and CYP2B6 within 30 days prior to dosing
- •10. Willing to refrain from alcohol and caffeine from 48 hours before first dose through the last dose of study drug
- •11. Subjects who smoke no more than 2 cigarettes or equivalent per week can be included in the study but must be willing to abstain from smoking during the confinement period.
- •12. Willing and able to provide written informed consent
排除标准
- •1. History of seizures, convulsions or increased intra-cranial pressure with the exception of pediatric febrile seizures
- •2. History of moderate or severe psychiatric illness
- •3. Has an active malignancy, or history of malignancy, excluding basal or squamous cell carcinoma of the skin, within 2 years prior to screening
- •4. History of cardiovascular, cerebrovascular, or peripheral vascular disease, including, but not limited to, unstable angina, myocardial infarction, congestive heart failure, cardiac arrhythmia, hypertension, hypotension, bradycardia, or tachycardia.
- •5. Has a clinically significant history or presence of electrocardiogram (ECG) findings as judged by the PI or designee at screening
- •6. Has clinically significant laboratory abnormalities
- •7. History of moderate or severe substance abuse within 5 years prior to screening
- •8. History of alcohol abuse within 5 years prior to screening
- •9. Positive alcohol breath test or urine test for drugs of abuse
- •10. Positive test results for hepatitis B surface antigen, hepatitis B core antibodies, hepatitis C virus antigen, and anti-human immunodeficiency virus (HIV) type 1 antibody
- •11. Has received treatment with another investigational drug, investigational device, or approved therapy for investigational use within 30 days or 5 half-lives (whichever is longer) prior to dosing; prior participation at any time in non-invasive methodology trials in which no drugs were given is acceptable.
- •12. Has taken a Serotonin-Norepinephrine Reuptake Inhibitors or Selective Serotonin Reuptake Inhibitor or benzodiazepine within 30 days prior to dosing.
- •13. Prior use of a 5-alpha reductase inhibitor within 3 months prior to dosing.
- •14. Has donated blood or plasma within 30 days prior to screening, or had a loss of whole blood of more than 500 mL within the 30 days prior to screening, or receipt of a blood transfusion within one year prior to screening
- •15. Has experienced symptoms of acute illness or chronic disease within 14 days prior to screening, or any disease or condition that, by the determination of the PI, might compromise interpretation of safety or PK data, or would place the subject at risk as a result of participation in the study.
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