ACTRN12622001571763撤回1 期
A Phase 1 Single Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EARLI-001
Earli Pty. Ltd.0 个研究点目标入组 10 人开始时间: 2022年12月20日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 10
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
- Non-randomised trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1. Be willing and able to sign the informed consent and comply with study procedures.
- •2. Be between the ages of 18 and 55, inclusive
- •3. Be male or female and meet the following conditions:
- •- Female participants must not have childbearing potential, defined as surgically sterile (hysterectomy, bilateral salpingectomy, tubal ligation or bilateral oophorectomy - verbal confirmation through medical history review acceptable) or postmenopausal (no menses for 12 months and confirmed by FSH level greater than or equal to 40 mlU/mL), or, if of childbearing potential be non-pregnant or lactating and agree to use highly effective contraception from screening through Day 30.
- •- Male participants, if not surgically sterilized, and 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 semen during this same period.
- •- Participants who abstain from intercourse as their usual and preferred lifestyle or participants with a same-sex partner are not required to use contraception as described above. They are required to maintain abstinence from screening through Day 30.
- •4. Be considered healthy by the Investigator, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs
- •5. Have a BMI between 18-32 Kg/m2
- •6. Weigh more than 50 kg.
- •7. Be a nonsmoker, defined as not having smoked, vaped or used any form of tobacco for more than 6 months before screening. Subjects who smoke occasionally (no more than 2 cigarettes per week) are allowed to participate provided their cotinine test is negative at screening and baseline and they abstain from smoking during the study.
- •8. Be willing to stop all prescription or over-the-counter medications they are currently taking from 7 days prior to admission to Day 7 of the study..
- •9. Be willing to abide by the study-specific restrictions on diet and exercise as described in the informed consent.
- •10. Not have participated in a clinical trial within the last 30 days prior to screening, or 5 half-lives, whichever is longer
排除标准
- •1. A prior history of cancer.
- •2. A positive blood screen for human immunodeficiency virus antibodies (HIV), hepatitis B surface or core antigen (HBsAg/HBcAg), or hepatitis C antigen
- •3. A history of clinically significant symptomatic hypotension.
- •4. Abnormal systolic or diastolic BP or heart rate outside of the Linear acceptable limits at Screening or Day -1.
- •5. Congenital long QT syndrome or QTcF > 450 ms (males) or >470 ms (females) by history or at Screening ECG.
- •6. WBC, neutrophils, hemoglobin and platelet counts out of the local laboratory range of normal.
- •7. AST, ALT or bilirubin value > upper limit of normal (ULN) at screening. Repeat testing one time is acceptable.
- •8. Serum creatinine > ULN at screening.
- •9. A hospital admission or major surgery within 30 days prior to screening
- •10. A pre-planned hospital admission or surgery scheduled within 30 days after dosing.
- •11.. A history of prescription drug abuse or illicit drug use within 6 months prior to screening
- •12. A history of alcohol abuse within 6 months prior to screening as determined by the PI
- •13.A positive screen for alcohol or drugs of abuse including cotinine
- •14. Donated more than one unit of blood or blood products during the 3 months prior to screening or receipt of a blood transfusion within one year prior to screening.
- •15. Any other co-morbidity or habit that the Investigator believes will interfere with their ability to comply with and complete the study.
研究者
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