A randomized, double-blind, placebo-controlled, single and multiple ascending dose and food effect evaluation trial to evaluate the safety, tolerability, and pharmacokinetics of AQ280 in healthy subjects

Aqilion AB0 个研究点目标入组 64 人开始时间: 2022年7月8日最近更新: 2023年4月17日

适应症

试验速览

暂无简介。

•1. Males or females, of any race, between 18 and 65 years of age, inclusive.
•2. Body mass index between 18.0 and 32.0 kg/m², inclusive.
•3. In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at screening and check-in and from the physical examination at check-in, as assessed by the investigator (or designee).
•4. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception
•5. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

•1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
•2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator (or designee).
•3. History of any surgical (eg, stomach or intestinal surgery or resection) or medical condition that would potentially alter absorption, distribution, metabolism, and/or excretion of orally administered drugs. Uncomplicated appendectomy and hernia repair will be allowed. Cholecystectomy will not be allowed.
•4. History of any significant infectious disease, as assessed by the investigator, within 2 weeks prior to the first dose of IMP.
•5. AST and/or ALT values >1.2 × ULN.
•6. Congenital nonhemolytic hyperbilirubinaemia (including suspicion of Gilbert’s syndrome).
•7. Hemoglobin value, neutrophil count, and/or lymphocyte count < lower limit of normal.
•8. Clinically significant abnormal ECG at screening or check-in.
•9. Positive hepatitis panel and/or positive human immunodeficiency virus test. Subjects whose results are compatible with prior immunization may be included at the discretion of the investigator
•10. Current active tuberculosis based on Quantiferon™ tuberculosis (TB) Gold test.

发起方