A Study of A4368 in Healthy Subjects

Study Overview
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Brief Summary
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A4368 is the autophagy activator that is being developed for the treatment of nonalcoholic steatohepatitis. The goal of the study is to assess the safety, tolerability, and pharmacokinetics in healthy subjects.

Official Title
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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

Conditions
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Health Subjects

Intervention / Treatment
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* Drug: A4368 or placebo tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female subjects Subject with a body weight of ≥ 55.0 kg and within an ideal body weight ± 20% Consent to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of study drug Willing and able to sign the informed consent form Exclusion Criteria: History of or current clinically significant medical illness History of or current gastrointestinal disease or surgery that can influence in pharmacokinetics of study drug Clinically significant history of hypersensitivity to study drug or any of the excipients of study drug Pregnant or lactating woman Clinically significant abnormal laboratory values for hematology, clinical chemistry, or urinalysis Clinically significant abnormal physical examination, vital signs, or 12-lead ECG Heavy alcohol or caffeine intake or heavy smoker Use of study drug in concurrent interventional study within 180 days prior to the first dose of study drug Use of any drug that may affect drug metabolic enzymes within 30 days prior to the first dose of study drug Donation of whole blood within 60 days or apheresis within 30 days prior to the first dose of study drug Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 14 days prior to the first dose of study drug

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A4368 - Dose 1<br>Single dose of A4368 or placebo tablet, orally administered | Drug: A4368 or placebo tablet<br>* orally administered<br>|
| Experimental: A4368 - Dose 2<br>Single dose of A4368 or placebo tablet, orally administered | Drug: A4368 or placebo tablet<br>* orally administered<br>|
| Experimental: A4368 - Dose 3<br>Single dose of A4368 or placebo tablet, orally administered | Drug: A4368 or placebo tablet<br>* orally administered<br>|
| Experimental: A4368 - Dose 4<br>Single dose of A4368 or placebo tablet, orally administered | Drug: A4368 or placebo tablet<br>* orally administered<br>|
| Experimental: A4368 - Dose 5<br>Single dose of A4368 or placebo tablet, orally administered | Drug: A4368 or placebo tablet<br>* orally administered<br>|
| Experimental: A4368 - Dose 6<br>Single dose of A4368 or placebo tablet, orally administered | Drug: A4368 or placebo tablet<br>* orally administered<br>|
| Experimental: A4368 - Dose 1 repeated<br>Multiple dose of A4368 or placebo tablet, orally administered daily for 14 consecutive days | Drug: A4368 or placebo tablet<br>* orally administered<br>|
| Experimental: A4368 - Dose 2 repeated<br>Multiple dose of A4368 or placebo tablet, orally administered daily for 14 consecutive days | Drug: A4368 or placebo tablet<br>* orally administered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | The number of subjects with adverse events and abnormal laboratory values | Up to 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentration of A4368 | The pharmacokinetics of A4368 in healthy subjects | From pre-dose to 48 hours post-dose |