A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-20805 in Healthy Subjects

Argo Biopharma Australia Pty Ltd0 个研究点目标入组 32 人开始时间: 2023年6月26日最近更新: 2024年8月26日

适应症

试验速览

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•1. Must have given written informed consent and be able to comply with all study requirements.
•2. Males or females aged 18 to 60 aged years, inclusive, at the time of informed consent.
•3. BMI (more than equal to) 18 and (less than equal to) 32 kg/m2 with body weight >50 kg.

•1. Any clinically significant chronic medical condition or clinically significant abnormality
•in laboratory parameters that, in the opinion of the investigator, makes the subject
•unsuitable for participation in the study.
•2. Hospitalization for any reason within 60 days prior to screening.
•3. Any clinically significant acute condition such as fever (>38 degree centigrade) or acute respiratory illness within 7 days of study drug administration.
•4. Systolic blood pressure (more than equal to) 140 mmHg and/or diastolic blood pressure (more than equal to) 90 mmHg after at least 5 minutes resting (seated or supine) at screening and Day -1.
•5. Any liver function panel analyte value greater than upper limits of normal (ULN) which
•includes aspartate transaminase (AST), alanine transaminase (ALT), total bilirubin
•(TBIL), and alkaline phosphatase (ALP) at screening and Day -1.
•6. International normalized ratio (INR) above 1.2 × ULN at screening and Day -1.
•7. Triplicate 12-lead electrocardiogram (ECG) with clinically significant abnormalities at
•screening and Day -1, as determined by the clinical investigator.
•8. History or clinical evidence of alcohol abuse, within the 12 months before screening.
•9. History or clinical evidence of drug abuse, within the 12 months before screening.
•10. Donated or lost >200 mL of blood within 30 days prior to screening.

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