Phase I clinical trial to investigate the safety, tolerability and pharmacokinetics of A4368 in healthy subjects
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0006346
- Lead Sponsor
- Autophagy Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 78
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: adverse event
- Secondary Outcome Measures
Name Time Method Safety: physical examination, vital sign;Safety: laboratory test;Safety: ECG;Pharmacokineitc parameters (SAD): Cmax, AUC, Tmax, , t1/2, CL/F, Vd/F, fe, CLR ;Pharmacokinetic parameters (MAD): Cmax, Cmax,ss, Cmin,ss, Cav,ss, AUC, Tmax, Tmax,ss, t1/2, PTF, Accumulation ratio, CLss/F, Vd,ss/F