NL-OMON51482招募中不适用
A Phase 1, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of PRAX-628 in Healthy Participants. - PRAX-628 in HV
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 112
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Willing and able to provide informed consent indicating that they understand
- •the purpose of the clinical trial and the procedures that are required for the
- •clinical trial, and that they are willing to comply with scheduled visits, and
- •all studyrelated procedures.
- •2. Male or female between the ages of 18 and 55 years, inclusive.
- •3. Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and a total body
- •weight of at least 50 kg.
- •4. Females of childbearing potential are not pregnant or breast-feeding, have a
- •negative serum pregnancy test at Screening and a negative urine pregnancy test
- •at Baseline and are not planning to get pregnant for the duration of the trial.
- •5. Female of nonchildbearing potential by reason of surgery or at least 1 year
- •postmenopausal (ie, 12 months since last menses) with confirmation by follicle
- •stimulating hormone (FSH) at Screening only,
- •Female of childbearing potential who is willing to use a highly effective
- •method or methods of contraception as defined in this protocol and for the
- •duration prescribed in this protocol,
- •Male who is willing and able to use a highly effective method or methods of
- •contraception as defined in this protocol and for the duration prescribed in
- •this protocol.
排除标准
- •1. Any clinically significant abnormalities, medical, or psychiatric conditions
- •identified by a detailed medical history, or physical examination, that in the
- •opinion of the investigator would pose an additional safety risk to the
- •participant or compromise the objectives of the study.
- •2. A history of cardiac disease(s)/cardiac conduction disorders/or cardiac
- •structural abnormality(ies) (e.g., atrial or ventricular septal defects,
- •valvular heart disease, coarctation of the aorta, or hypertrophic obstructive
- •cardiomyopathy).
- •3. Has a history of any lifetime suicide attempt or active suicidal ideation as
- •confirmed by C-SSRS Baseline Version (Part B only).
- •4. Any surgical or medical condition which might significantly alter the
- •absorption, distribution, metabolism, or excretion of drugs or which may
- •jeopardize the participant in case of participation in the study. Examples of
- •such conditions include (but are not limited to):
- •a. History of inflammatory bowel syndrome, gastritis, gastrointestinal or
- •rectal bleeding;
- •b. History of major gastrointestinal tract surgery (ie, gastrectomy, bowel
- •resection, etc.);
- •c. History or evidence of pancreatic injury or pancreatitis;
- •d. History or presence of impaired renal function as indicated by abnormal
- •renal function (estimated glomerular filtration rate [eGFR] <90 mL/min/1.73m2)
- •or abnormal urinary constituents (eg, albuminuria).
- •5. Abnormal vital signs after at least 5 minutes resting in the supine
- •a. Systolic blood pressure <=90 or >=140 mmHg
- •b. Diastolic blood pressure <=40 or >=90 mmHg
- •c. Heart rate <=40 or >=100 bpm
- •d. Body temperature <=35.5°C or >=37.5°C
- •6. Abnormal standard 12-lead ECG after at least 5 minutes resting in the supine
- •a. PR interval <120 with evidence of pre-excitation syndrome (e.g, delta wave)
- •or >220 ms
- •b. QRS >120 ms
- •c. QTcF <320 ms or >=450 ms if male or <320 ms or >=470 ms if female
- •7. Any finding that, in the judgement of the investigator, is a clinically
- •significant abnormality, including serum chemistry, hematology, coagulation,
- •and urinalysis test values (abnormal test results may be repeated for
- •confirmation).
- •8. An elevation of >=1.5× ULN for AST or ALT/ serum glutamic pyruvic
- •transaminase (SGPT) or >=2×ULN for total bilirubin.
- •9. Positive test for HIV, hepatitis B (HBsAg), or hepatitis C.
- •10. History of drug or alcohol abuse.
- •11. Positive drug or alcohol test at Screening or Baseline. (Abnormal test
- •results may be repeated for confirmation).
- •12. Smoker (use of tobacco or nicotine-containing products in the previous 3
- •months) or evidence of such use as indicated by cotinine testing at Screening
- •and Baseline.
- •13. Use of an investigational drug or device within 90 days or 5 half-lives
- •preceding the first dose of study drug, whichever is longer.
- •14. Use of prescription or nonprescription drugs or dietary or herbal
- •supplements of clinical concern within 7 days or within 5 times the elimination
- •half-life (whichever is longer) prior to the first dose of study drug. Refer to
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研究者
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