An alternating panel, single ascending dose trial to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, relative bioavailability, and food effect of orally administered AS-1763 in healthy subjects - SAD study investigating safety, tolerability, PK and PD of AS-1763

Carna Biosciences, Inc.0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年4月9日

试验速览

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•1. Must have signed an ICF prior to screening, indicating that he/she
•understands the purpose of, and procedures required for, the trial and are
•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; weight in kg divided by length in square meters)
•between 18.0 and 30.0 kg/m2, inclusive, at screening.
•4. Good physical and mental health as established by medical history, physical
•examination, electrocardiogram (ECG) and vital signs (including temporal body
•temperature) recording, and results of biochemistry, 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, as confirmed by a urine cotinine test at screening and on
•Day -1 of the first treatment period of each cohort.

•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, 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 laboratory, ECG recordings, vital signs or
•physical findings at screening or on Day -1 of the first treatment period, as
•judged by the investigator.
•3. Values of hepatic aminotransferase (ALT and/or AST) > 1.5 × the upper limit
•of normal range (ULN) at screening or on Day -1 of the first treatment period.
•4. Values of GGT and/or ALP > 1.25 x ULN at screening or on Day -1 of the first
•treatment period.
•5. Values of total bilirubin > ULN at screening or on Day -1 of the first
•treatment period.

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