A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 Injection for Subcutaneous Use in Healthy Subjects

ASC47-101

This will be a phase I, randomized, double-blind, placebo-controlled, single-dose escalation study. This study will be conducted in three periods: the screening period , the treatment period and the follow-up period. This study aims to evaluate the pharmacokinetics, target engagement and pharmacodynamic biomarkers of ASC47 in healthy subjects.

2024-06-01

2024-12-01

2025-04-01

Not yet recruiting

Early phase I

36

Key inclusion Criteria: * Subject have provided informed consent before initiation of any study-specific procedures * Healthy male subjects or female subjects, between 18 and 55 years of age (inclusive). * Females who are not pregnant or breastfeeding, or do not plan to become pregnant within 6 months and are willing to use effective contraceptive measures from the first dose of the investigational product until 3 months after the last dose are eligible. * In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures, eg. Key exclusion Criteria: * Have a clinically relevant acute or chronic medical condition or disease of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, or dermatologic systems as assessed by the investigator. * Have any current or historical disease or disorder of the hematological system or significant liver disease or family history of bleeding/platelet disorders. * Have a history of cancer (other than basal cell or squamous cell cancer of the skin which is fully excised), rheumatologic disease or blood dyscrasia. * Have a history of febrile illness within 14 days prior to screening. * Have a positive alcohol or drug screen at Screening or have a history of alcohol or drug abuse within the past 1 years. * Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised. * Have used prescription drugs (other than hormone replacement therapy and medications for contraceptive purpose) within 14 days prior to the first dose of Investigational product.

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2024-05-29