Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of ASC42 in Healthy Subjects

Gannex Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ASC42; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04679129

ASC42-I-CTP-01

Details and patient eligibility

About

This is a first in human study of single and multiple ascending doses and food effect of ASC42.

This study consists of 8 cohorts and is divided as follows:

Part Ia: Single ascending doses study including cohorts 1 to 5. Part Ib: A cross-over design of cohort 2 to study the food effect on ASC42 PK. Part II: Multiple ascending doses study including cohorts 6 to 8.

Enrollment: 64 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Healthy male and female subjects between 18 to 65 years of age.
• Subjects' weight ≥ 50 kg and BMI within the range of 19 - 29 kg/m2.
• Physical examination and vital signs are within normal range or slightly abnormal.

Key Exclusion Criteria:

• History or current liver disease, or liver injuries.
• A positive HBsAg, HCV Ab and/or HIV Ab.
• Platelet count <150,000/mcL
• INR> 1.2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 4 patient groups, including a placebo group

Single Ascending Dose-ASC42

Experimental group

Description:

ASC42 tablet，Dose 1，Dose 2，Dose 3，Dose 4，and Dose 5, single dose administration

Treatment:

Drug: ASC42

Multiple Ascending Dose-ASC42

Experimental group

Description:

ASC42 tablet, Dose 1，Dose 2，Dose 3，q.d.×14 days

Treatment:

Drug: ASC42

Single Ascending Dose-Placebo

Placebo Comparator group

Description:

Placebo tablet，Dose 1，Dose 2，Dose 3，Dose 4，and Dose 5, single dose administration

Treatment:

Drug: Placebo

Multiple Ascending Dose-Placebo

Placebo Comparator group

Description:

Placebo tablet，Dose 1，Dose 2，Dose 3，q.d.×14 days

Treatment:

Drug: Placebo