A Study of A4368 in Healthy Subjects (A4368)

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

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.

Study Overview

• Status: Completed
• Conditions: Health Subjects
• Intervention / Treatment: Drug: A4368 or placebo tablet

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Inhyang Kim; Phone Number: +82221357957; Email: ihkim@autophagysci.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • AutophagySciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Autophagy Sciences, Inc.
• Investigators: Principal Investigator: Seunghoon Han, Seoul st. mary's hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2021
• Primary Completion (Actual): July 25, 2022
• Study Completion (Actual): July 25, 2022

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 21, 2021

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: AS101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No