Health SubjectsPhase 1A4368NCT04932252
A Study of A4368 in Healthy Subjects
A Phase 1 study of Health Subjects, run by Autophagy Sciences, Inc. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Subjects
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Sep 2021to 25 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- A4368 or placebo tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A4368 or placebo tabletDrug
orally administered
| Study group | Role | What they receive |
|---|---|---|
| A4368 - Dose 1 | Experimental | Single dose of A4368 or placebo tablet, orally administered Receives: Drug: A4368 or placebo tablet |
| A4368 - Dose 2 | Experimental | Single dose of A4368 or placebo tablet, orally administered Receives: Drug: A4368 or placebo tablet |
| A4368 - Dose 3 | Experimental | Single dose of A4368 or placebo tablet, orally administered Receives: Drug: A4368 or placebo tablet |
| A4368 - Dose 4 | Experimental | Single dose of A4368 or placebo tablet, orally administered Receives: Drug: A4368 or placebo tablet |
| A4368 - Dose 5 | Experimental | Single dose of A4368 or placebo tablet, orally administered Receives: Drug: A4368 or placebo tablet |
| A4368 - Dose 6 | Experimental | Single dose of A4368 or placebo tablet, orally administered Receives: Drug: A4368 or placebo tablet |
| A4368 - Dose 1 repeated | Experimental | Multiple dose of A4368 or placebo tablet, orally administered daily for 14 consecutive days Receives: Drug: A4368 or placebo tablet |
| A4368 - Dose 2 repeated | Experimental | Multiple dose of A4368 or placebo tablet, orally administered daily for 14 consecutive days Receives: Drug: A4368 or placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
The number of subjects with adverse events and abnormal laboratory values
Measured: Up to 21 days
Secondary outcomes (1)
Serum concentration of A4368
The pharmacokinetics of A4368 in healthy subjects
Measured: From pre-dose to 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start7 Sep 2021
- Primary completion25 Jul 2022
- Study completion25 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Autophagy Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seunghoon Han, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932252
- Sponsor's protocol ID
- AS101
- Acronym
- A4368
- Status last verified
- Dec 2022
- First submitted
- 3 Jun 2021
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04932252
- Acronym / sponsor ID
- A4368 / AS101
- Conditions
- Health Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Autophagy Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| A4368 - Dose 1 | Experimental | Drug: A4368 or placebo tabletSingle dose of A4368 or placebo tablet, orally administered |
| A4368 - Dose 2 | Experimental | Drug: A4368 or placebo tabletSingle dose of A4368 or placebo tablet, orally administered |
| A4368 - Dose 3 | Experimental | Drug: A4368 or placebo tabletSingle dose of A4368 or placebo tablet, orally administered |
| A4368 - Dose 4 | Experimental | Drug: A4368 or placebo tabletSingle dose of A4368 or placebo tablet, orally administered |
| A4368 - Dose 5 | Experimental | Drug: A4368 or placebo tabletSingle dose of A4368 or placebo tablet, orally administered |
| A4368 - Dose 6 | Experimental | Drug: A4368 or placebo tabletSingle dose of A4368 or placebo tablet, orally administered |
| A4368 - Dose 1 repeated | Experimental | Drug: A4368 or placebo tabletMultiple dose of A4368 or placebo tablet, orally administered daily for 14 consecutive days |
| A4368 - Dose 2 repeated | Experimental | Drug: A4368 or placebo tabletMultiple dose of A4368 or placebo tablet, orally administered daily for 14 consecutive days |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A4368 or placebo tabletorally administered | Drug | 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 |
Primary outcome
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
1 secondary outcome
Serum concentration of A4368
Time frame: From pre-dose to 48 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
Related trials for Health Subjects
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Acute Effects of High-Intensity Laser Therapy on Pain, Muscle Stiffness, and Grip Strength in Healthy Adults
Exercise-Induced Muscle Fatigue, Fatigue Recovery
RecruitingObservational study
A Muscle-brain Interplay Study in Neurological Disorders
Neurological Disorders, Health Adult Subjects
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seunghoon Han principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Health Subjects, run by Autophagy Sciences, Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) (time frame: Up to 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.