A Study of A4368 in Healthy Subjects

Health Subjects Clinical Trial

— A4368  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04932252
• Other study ID #: AS101
• Status: Completed
• Phase: Phase 1
• Start date: September 7, 2021
• Est. completion date: July 25, 2022

Study information

• Verified date: December 2022
• Source: Autophagy Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: July 25, 2022
• Est. primary completion date: July 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Subjects

Intervention

Drug:
• A4368 or placebo tablet
orally administered

Locations

Country	Name	City	State
Korea, Republic of	AutophagySciences	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Autophagy Sciences, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Serum concentration of A4368	The pharmacokinetics of A4368 in healthy subjects	From pre-dose to 48 hours post-dose