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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- 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
Arms & Interventions
A4368 - Dose 1
Single dose of A4368 or placebo tablet, orally administered
Intervention: A4368 or placebo tablet (Drug)
A4368 - Dose 2
Single dose of A4368 or placebo tablet, orally administered
Intervention: A4368 or placebo tablet (Drug)
A4368 - Dose 3
Single dose of A4368 or placebo tablet, orally administered
Intervention: A4368 or placebo tablet (Drug)
A4368 - Dose 4
Single dose of A4368 or placebo tablet, orally administered
Intervention: A4368 or placebo tablet (Drug)
A4368 - Dose 5
Single dose of A4368 or placebo tablet, orally administered
Intervention: A4368 or placebo tablet (Drug)
A4368 - Dose 6
Single dose of A4368 or placebo tablet, orally administered
Intervention: A4368 or placebo tablet (Drug)
A4368 - Dose 1 repeated
Multiple dose of A4368 or placebo tablet, orally administered daily for 14 consecutive days
Intervention: A4368 or placebo tablet (Drug)
A4368 - Dose 2 repeated
Multiple dose of A4368 or placebo tablet, orally administered daily for 14 consecutive days
Intervention: A4368 or placebo tablet (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Serum concentration of A4368(From pre-dose to 48 hours post-dose)