A Study of A4368 in Healthy Subjects

NCT04932252 | Completed Phase 1 DMC

• 1 other identifier: AS101
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Subjects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Serum concentration of A4368

  From pre-dose to 48 hours post-dose

Study Arms (8)

A4368 - Dose 1

EXPERIMENTAL

Single dose of A4368 or placebo tablet, orally administered

Drug: A4368 or placebo tablet

A4368 - Dose 2

EXPERIMENTAL

Single dose of A4368 or placebo tablet, orally administered

Drug: A4368 or placebo tablet

A4368 - Dose 3

EXPERIMENTAL

Single dose of A4368 or placebo tablet, orally administered

Drug: A4368 or placebo tablet

A4368 - Dose 4

EXPERIMENTAL

Single dose of A4368 or placebo tablet, orally administered

Drug: A4368 or placebo tablet

A4368 - Dose 5

EXPERIMENTAL

Single dose of A4368 or placebo tablet, orally administered

Drug: A4368 or placebo tablet

A4368 - Dose 6

EXPERIMENTAL

Single dose of A4368 or placebo tablet, orally administered

Drug: A4368 or placebo tablet

A4368 - Dose 1 repeated

EXPERIMENTAL

Multiple dose of A4368 or placebo tablet, orally administered daily for 14 consecutive days

Drug: A4368 or placebo tablet

A4368 - Dose 2 repeated

EXPERIMENTAL

Multiple dose of A4368 or placebo tablet, orally administered daily for 14 consecutive days

Drug: A4368 or placebo tablet

Interventions

A4368 or placebo tablet DRUG

orally administered

A4368 - Dose 1; A4368 - Dose 1 repeated; A4368 - Dose 2; A4368 - Dose 2 repeated; A4368 - Dose 3; A4368 - Dose 4; A4368 - Dose 5; A4368 - Dose 6

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Autophagy Sciences, Inc.: lead

Study Sites (1)

AutophagySciences

Seoul, South Korea

Location

Study Officials

• Seunghoon Han

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 21, 2021
• Study Start: September 7, 2021
• Primary Completion: July 25, 2022
• Study Completion: July 25, 2022
• Last Updated: January 18, 2023

Record last verified: 2022-12

Locations

KR (1)