NL-OMON53402已完成不适用
A Phase 1 trial to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of AS-0871 and to evaluate the relative bioavailability and the food effect of new oral formulations of AS-0871 in healthy subjects. - Safety, PK and PD study of AS-0871 in healthy subjects
试验速览
- 阶段
- 不适用
- 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
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Must have signed an ICF prior to screening, indicating that he/she
- •understands the purpose of, and procedures required for, the trial, and
- •indicating that he/she is willing to participate in the trial.
- •2. Healthy males or females of non-childbearing potential, between 18 and 64
- •years of age, inclusive, at screening.
- •3. Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at screening.
- •4. Good physical and mental health as established by medical history, physical
- •examination, ECG, and vital signs (including temporal body temperature)
- •recording, and results of biochemistry, coagulation (Part 2 only), hematology,
- •and urinalysis tests during screening as judged by the investigator.
- •5. Non-smoker/non-user of nicotine-containing products for at least 3 months
- •prior to screening, to be confirmed by a urine cotinine test at screening and
- •on Day -1 (of the first treatment period, as applicable).
- •Further criteria apply, see protocol.
排除标准
- •1. History of or current clinically significant medical illness including (but
- •not limited to) gastrointestinal, cardiovascular, neurologic, psychiatric,
- •metabolic, endocrinologic, genitourinary, renal, hepatic, respiratory,
- •inflammatory, neoplastic, hematologic (including coagulation disorders), or
- •infectious disease, or any other illness that the investigator considers should
- •exclude the subject or that could interfere with the interpretation of the
- •trial results.
- •2. Clinically relevant abnormal values for hematology, coagulation (Part 2
- •only), biochemistry, or urinalysis at screening or on Day -1 (of the first
- •treatment period, as applicable), as judged by the investigator.
- •3. Values of hepatic aminotransferase (ALT and/or AST) >1.5xULN at screening or
- •on Day -1 (of the first treatment period, as applicable).
- •4. Values of GGT and/or ALP >1.25xULN at screening or on Day -1 (of the first
- •treatment period, as applicable).
- •5. Values of total cholesterol and LDL cholesterol >1.25xULN at screening or on
- •Day -1 (of the first treatment period, as applicable).
- •Further criteria apply, see protocol.
研究者
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