A Study of A4368 in Healthy Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04932252

Acronym

A4368

Enrollment

Registered

2021-06-21

Start date

2021-09-07

Completion date

2022-07-25

Last updated

2023-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Subjects

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.

Interventions

DRUGA4368 or placebo tablet

orally administered

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026