A dose block-randomized, double blinded, placebo controlled, dose-escalation clinical trial to find the maximal tolerable dose and to evaluate the safety, tolerability and pharmacokinetics after single and multiple oral doses of A4368 in healthy subjects

Autophagy Sciences0 个研究点目标入组 78 人开始时间: 待定最近更新: 2021年8月30日

试验速览

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•1. Healthy male and female subjects between 20 and 45 years of age
•2. Subject with a body weight of = 55.0 kg and within an ideal body weight ± 20%
•3. Consent to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of IMP
•4. Willing and able to sign the informed consent form

•1. History of or current clinically significant medical illness
•2. History of or current gastrointestinal disease or surgery that can influence in pharmacokinetics of IMP
•3. Clinically significant history of hypersensitivity to IMP or any of the excipients contained within the IMP
•4. Pregnant or lactating woman
•5. Clinically significant abnormal laboratory values for hematology, clinical chemistry, or urinalysis
•6. Clinically significant abnormal physical examination, vital signs, or 12-lead ECG
•7. Genetic problems such as galactose intolerance, Lapp lactate deficiency, or glucose-galactose absorption disorder
•8. Heavy alcohol or caffeine intake or heavy smoker
•9. Use of IMP in concurrent interventional study within 180 days prior to the first dose of IMP
•10. Use of any drug that may affect drug metabolic enzymes within 30 days prior to the first dose of IMP
•11. Donation of whole blood within 60 days or apheresis within 30 days prior to the first dose of IMP
•12. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 14 days prior to the first dose of IMP
•13. Use of any vaccine or immunosuppressant within 28 days prior to the first dose of IMP

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