A Study of A4368 in Healthy Subjects

Phase 1

Completed

• Conditions: Health Subjects
• Interventions: Drug: A4368 or placebo tablet

• Registration Number: NCT04932252
• Lead Sponsor: Autophagy Sciences, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-03
• Study First Submitted QC: 2021-06-17
• Study First Posted: 2021-06-21
• Study Start: 2021-09-07
• Primary Completion: 2022-07-25
• Study Completion: 2022-07-25
• Status Verified: 2022-12
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

1. Healthy male and female subjects
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 study drug
4. Willing and able to sign the informed consent form

Exclusion Criteria

1. History of or current clinically significant medical illness
2. History of or current gastrointestinal disease or surgery that can influence in pharmacokinetics of study drug
3. Clinically significant history of hypersensitivity to study drug or any of the excipients of study drug
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. Heavy alcohol or caffeine intake or heavy smoker
8. Use of study drug in concurrent interventional study within 180 days prior to the first dose of study drug
9. Use of any drug that may affect drug metabolic enzymes within 30 days prior to the first dose of study drug
10. Donation of whole blood within 60 days or apheresis within 30 days prior to the first dose of study drug
11. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 14 days prior to the first dose of study drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A4368 - Dose 3	A4368 or placebo tablet	Single dose of A4368 or placebo tablet, orally administered
A4368 - Dose 6	A4368 or placebo tablet	Single dose of A4368 or placebo tablet, orally administered
A4368 - Dose 1	A4368 or placebo tablet	Single dose of A4368 or placebo tablet, orally administered
A4368 - Dose 2 repeated	A4368 or placebo tablet	Multiple dose of A4368 or placebo tablet, orally administered daily for 14 consecutive days
A4368 - Dose 5	A4368 or placebo tablet	Single dose of A4368 or placebo tablet, orally administered
A4368 - Dose 1 repeated	A4368 or placebo tablet	Multiple dose of A4368 or placebo tablet, orally administered daily for 14 consecutive days
A4368 - Dose 2	A4368 or placebo tablet	Single dose of A4368 or placebo tablet, orally administered
A4368 - Dose 4	A4368 or placebo tablet	Single dose of A4368 or placebo tablet, orally administered

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	Up to 21 days	The number of subjects with adverse events and abnormal laboratory values

Secondary Outcome Measures

Name	Time	Method
Serum concentration of A4368	From pre-dose to 48 hours post-dose	The pharmacokinetics of A4368 in healthy subjects

Trial Locations

Locations (1)

AutophagySciences; 🇰🇷 Seoul, Korea, Republic of