Skip to main content
OpenTrials
Completed

NCT Number: NCT04932252

A Study 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

AutophagySciences

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A4368 or placebo tablet

Drug

orally administered

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

    Time frame: Up to 21 days

    The number of subjects with adverse events and abnormal laboratory values

Secondary outcomes

  1. Serum concentration of A4368

    Time frame: From pre-dose to 48 hours post-dose

    The pharmacokinetics of A4368 in healthy subjects

Sponsors and collaborators

Lead sponsor

Autophagy Sciences, Inc.

Industry

Registry information

Official study 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

Acronym: A4368

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 21, 2021
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.