A Study of A4368 in Healthy Subjects

Autophagy Sciences

Status and phase: Completed; Phase 1

Conditions: Health Subjects

Treatments: Drug: A4368 or placebo tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT04932252

AS101

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

78 participants in 8 patient groups

A4368 - Dose 1

Experimental group

Description:

Single dose of A4368 or placebo tablet, orally administered

Treatment:

Drug: A4368 or placebo tablet

A4368 - Dose 2

Experimental group

Description:

Single dose of A4368 or placebo tablet, orally administered

Treatment:

Drug: A4368 or placebo tablet

A4368 - Dose 3

Experimental group

Description:

Single dose of A4368 or placebo tablet, orally administered

Treatment:

Drug: A4368 or placebo tablet

A4368 - Dose 4

Experimental group

Description:

Single dose of A4368 or placebo tablet, orally administered

Treatment:

Drug: A4368 or placebo tablet

A4368 - Dose 5

Experimental group

Description:

Single dose of A4368 or placebo tablet, orally administered

Treatment:

Drug: A4368 or placebo tablet

A4368 - Dose 6

Experimental group

Description:

Single dose of A4368 or placebo tablet, orally administered

Treatment:

Drug: A4368 or placebo tablet

A4368 - Dose 1 repeated

Experimental group

Description:

Multiple dose of A4368 or placebo tablet, orally administered daily for 14 consecutive days

Treatment:

Drug: A4368 or placebo tablet

A4368 - Dose 2 repeated

Experimental group

Description:

Multiple dose of A4368 or placebo tablet, orally administered daily for 14 consecutive days

Treatment:

Drug: A4368 or placebo tablet