A Study of A4368 in Healthy Subjects

Sponsor

Autophagy Sciences, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04932252

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Health Subjects	Drug: A4368 or placebo tablet	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Serum concentration of A4368 [From pre-dose to 48 hours post-dose]
The pharmacokinetics of A4368 in healthy subjects

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Autophagy Sciences, Inc.

Investigators

Principal Investigator: Seunghoon Han, Seoul St. Mary's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Autophagy Sciences, Inc.

ClinicalTrials.gov Identifier:

NCT04932252

Other Study ID Numbers:

AS101

First Posted:

Jun 21, 2021

Last Update Posted:

Jun 21, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 21, 2021