ACTRN12623000760673招募中1 期
A Double-Blinded, Randomized, Placebo-controlled, Single-And Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics Of ELVN-001 In Normal Healthy Participants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
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 60 Years（—）
- 性别
- All
入选标准
- •To be eligible for this study, a participant must meet all of the following inclusion criteria:
- •1. Participants greater than and equal to 18 to lesser than 60 years of age at time of informed consent.
- •Type of Patient and Disease Characteristics
- •2. Normal healthy male and female participants with no clinically significant medical history, and no clinically significant abnormalities on physical examination at Screening and/or before the first administration of IP at the discretion of the PI or designee
- •General Inclusion Criteria
- •3. Able to provide written informed consent to participate in this study.
- •4. Healthy and free from clinically significant illness or disease with clinical laboratory values at Screening and Day -1 (including haematology, biochemistry, coagulation, and urinalysis) within normal range as specified by the testing laboratory, unless deemed not
- •clinically significant by the PI or designee.
- •5. Have a body mass index (BMI) between 18.5 and 30 kg/m2 , inclusive, and weigh at least 50 kg and no more than 100 kg, inclusive, at Screening.
- •6. Able to understand the nature of the study and any risks associated with participation and willing to cooperate and comply protocol restrictions and requirements.
- •7. Agrees to the meals, dietary and lifestyle restrictions outlined in the protocol during the course of the study.
- •8. Estimated glomerular filtration rate (eGFR): more than 89 mL per min per 1.73 meter square for participants 18 to 59 years old, or more than 84 mL per min per 1.73 meter square for participants 60 years old) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation.
- •9. Systolic blood pressure of 90 to 140 mmHg and diastolic blood pressure of 40 to 90 mmHg.
- •10. Resting heart rate of 45 to 100 beats per minute (bpm).
- •Reproductive Status
- •Male participants:
- •11. A male participant must agree to use contraception, during the treatment period and for at least 90 days after the last dose of IP and refrain from donating sperm during this period
- •Female participants:
- •12. A female participant is eligible to participate if she is not pregnant, not breastfeeding and at least one of the following conditions applies:
- •Not a woman of childbearing potential, OR
- •Must agree to use contraception, as detailed in the protocol, during the treatment period and for at least 90 days after the last dose of IP.
排除标准
- •Participants are excluded from the study if any of the following criteria apply. No waivers will be granted.
- •1. Previous participating a trial with ELVN-001.
- •2. Participating in another clinical trial and received any prescribed systemic or topical medications
- •within 30 days (or less than 5 half-lives, whichever is longer) prior to first dose of the IP.
- •3. Potential participant has used any other IP or investigational medical device within 30 days prior to Screening.
- •4. Family history (biological relatives [ie, parents, siblings]) of long or short QT syndrome, or Torsades de Pointes.
- •5. Abnormal ECG findings at Screening or Day -1 (eg, repeated demonstration of a QTc interval more than 450 ms (male) or more than 470 ms (female) corrected by Fridericia's formula [QTcF] or Bazett's formula [QTcB]) that are considered by the PI or designee to be clinically significant.
- •6. Presence or history of drug and or alcohol abuse including a positive result on the urine drug
- •screen or alcohol breath test at Screening or Day -1.
- •7. Excessive intake of caffeine-containing drinks or food as judged by the Investigator. Excessive
- •intake is defined as more than 400 mg of caffein per day (equivalent to 4 or 5 cups of brewed
- •8. Use of tobacco or nicotine-containing products within 3 months prior to first dose of IP and during the course of the study.
- •9. Test positive for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) 1 & HIV 2 antibodies. If a participant tests positive for HCV antibodies, they may still be allowed into the trial if HCV Ribonucleic acid [RNA] is undetectable in a follow-up assessment.
- •10. Plasma donation within 30 days of Screening or any blood loss or donation more than 500 mL
- •during the 90 days prior to Screening.
- •11. History or presence of gastrointestinal (including a previous episode of pancreatitis), hepatic or
- •renal disease, or any other conditions known to interfere with absorption, distribution,
- •metabolism, or excretion of drugs.
- •12. A female participant is pregnant or breastfeeding.
- •13. Unwillingness to refrain from strenuous exercise 48 hours prior to CRU confinement and for the
- •duration of the study.
- •14. History of lactose intolerance.
- •15. Positive cotinine test at Screening and Day -1.
- •16. Is at suicidal risk in the opinion of the PI as per the following criteria:
- •Any suicidal attempts within 12 months prior to Screening.
- •Any suicidal intent including a plan or Columbia-Suicide Severity Rating Scale (C-SSRS) answer
- •of YES on suicidal ideation currently or within 3 months.
- •Prior/Concomitant Therapy
- •17. Unwillingness to abstain from concomitant therapy for the duration of the study (with the exception of medications used to treat adverse symptoms associated with ELVN-001 administration and permitted contraception). Over the counter (OTC) medication, herbal remedies, supplements, or vitamins are not permitted for 7 days prior to dosing, and during the study without prior approval of the PI and designee.
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