Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
78 participants
INTERVENTIONAL
2021-09-07
2022-07-25
Brief Summary
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The goal of the study is to assess the safety, tolerability, and pharmacokinetics in healthy subjects.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A4368 - Dose 1
Single dose of A4368 or placebo tablet, orally administered
A4368 or placebo tablet
orally administered
A4368 - Dose 2
Single dose of A4368 or placebo tablet, orally administered
A4368 or placebo tablet
orally administered
A4368 - Dose 3
Single dose of A4368 or placebo tablet, orally administered
A4368 or placebo tablet
orally administered
A4368 - Dose 4
Single dose of A4368 or placebo tablet, orally administered
A4368 or placebo tablet
orally administered
A4368 - Dose 5
Single dose of A4368 or placebo tablet, orally administered
A4368 or placebo tablet
orally administered
A4368 - Dose 6
Single dose of A4368 or placebo tablet, orally administered
A4368 or placebo tablet
orally administered
A4368 - Dose 1 repeated
Multiple dose of A4368 or placebo tablet, orally administered daily for 14 consecutive days
A4368 or placebo tablet
orally administered
A4368 - Dose 2 repeated
Multiple dose of A4368 or placebo tablet, orally administered daily for 14 consecutive days
A4368 or placebo tablet
orally administered
Interventions
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A4368 or placebo tablet
orally administered
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
45 Years
ALL
Yes
Sponsors
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Autophagy Sciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Seunghoon Han
Role: PRINCIPAL_INVESTIGATOR
Seoul St. Mary's Hospital
Locations
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AutophagySciences
Seoul, , South Korea
Countries
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Other Identifiers
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AS101
Identifier Type: -
Identifier Source: org_study_id
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