4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / A Study of A4368 in Healthy Subjects (A4368)

A Study of A4368 in Healthy Subjects (A4368)

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : August 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 :
  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 Outcome Measures :
  1. Serum concentration of A4368 [ Time Frame: From pre-dose to 48 hours post-dose ]
    The pharmacokinetics of A4368 in healthy subjects


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Inhyang Kim +82221357957 ihkim@autophagysci.com

Sponsors and Collaborators
Autophagy Sciences, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Seunghoon Han Seoul St. Mary's Hospital
Tracking Information
First Submitted Date  ICMJE June 3, 2021
First Posted Date  ICMJE June 21, 2021
Last Update Posted Date June 21, 2021
Estimated Study Start Date  ICMJE October 2021
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2021) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2021) 		Serum concentration of A4368 [ Time Frame: From pre-dose to 48 hours post-dose ]
The pharmacokinetics of A4368 in healthy subjects
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of A4368 in Healthy Subjects
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Health Subjects
Intervention  ICMJE Drug: A4368 or placebo tablet
orally administered
Study Arms  ICMJE
  • Experimental: A4368 - Dose 1
    Single dose of A4368 or placebo tablet, orally administered
    Intervention: Drug: A4368 or placebo tablet
  • Experimental: A4368 - Dose 2
    Single dose of A4368 or placebo tablet, orally administered
    Intervention: Drug: A4368 or placebo tablet
  • Experimental: A4368 - Dose 3
    Single dose of A4368 or placebo tablet, orally administered
    Intervention: Drug: A4368 or placebo tablet
  • Experimental: A4368 - Dose 4
    Single dose of A4368 or placebo tablet, orally administered
    Intervention: Drug: A4368 or placebo tablet
  • Experimental: A4368 - Dose 5
    Single dose of A4368 or placebo tablet, orally administered
    Intervention: Drug: A4368 or placebo tablet
  • Experimental: A4368 - Dose 6
    Single dose of A4368 or placebo tablet, orally administered
    Intervention: Drug: A4368 or placebo tablet
  • Experimental: A4368 - Dose 1 repeated
    Multiple dose of A4368 or placebo tablet, orally administered daily for 14 consecutive days
    Intervention: Drug: A4368 or placebo tablet
  • Experimental: A4368 - Dose 2 repeated
    Multiple dose of A4368 or placebo tablet, orally administered daily for 14 consecutive days
    Intervention: Drug: A4368 or placebo tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 17, 2021) 		78
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Inhyang Kim +82221357957 ihkim@autophagysci.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04932252
Other Study ID Numbers  ICMJE AS101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Autophagy Sciences, Inc.
Study Sponsor  ICMJE Autophagy Sciences, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Seunghoon Han Seoul St. Mary's Hospital
PRS Account Autophagy Sciences, Inc.
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP