Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of ASC42 in Healthy Subjects
- Registration Number
- NCT04679129
- Lead Sponsor
- Gannex Pharma Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multiple Ascending Dose-ASC42 ASC42 ASC42 tablet, Dose 1，Dose 2，Dose 3，q.d.×14 days Single Ascending Dose-ASC42 ASC42 ASC42 tablet，Dose 1，Dose 2，Dose 3，Dose 4，and Dose 5, single dose administration Multiple Ascending Dose-Placebo Placebo Placebo tablet，Dose 1，Dose 2，Dose 3，q.d.×14 days Single Ascending Dose-Placebo Placebo Placebo tablet，Dose 1，Dose 2，Dose 3，Dose 4，and Dose 5, single dose administration
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Up to 21 days Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation and/or dose reductions, and AE of special interest, from baseline up to 21 days
- Secondary Outcome Measures
Name Time Method Cmax of ASC42 On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days. Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC42 administered to healthy volunteers.
Vd/F of ASC42 On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days. Evaluate the Apparent Volume of Distribution after single and multiple oral dose of ASC42 administered to healthy volunteers.
C4 On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days. Bile acid precuisor:C4 (7αhydroxy-4-cholesten-3-one)
FGF19 On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days. Bile acid precursor:FGF19 (Fibroblast growth factor 19)
t1/2 of ASC42 On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days. Evaluate the Terminal-Phase Half-Life after single and multiple oral doses of ASC42 administered to healthy volunteers.
AUC of ASC42 On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days. Evaluate the Area under the plasma concentration versus time curve after single and multiple oral doses of ASC42 administered to healthy volunteers.
CL/F of ASC42 On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days. Evaluate the Apparent Systemic Clearance after single and multiple oral dose of ASC42 administered to healthy volunteers.
Tmax of ASC42 On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days. Evaluate the Time to reach the maximum plasma concentration after single single and multiple oral doses of ASC42 administered to healthy volunteers.
Trial Locations
- Locations (1)
ICON early Phase Services LLC
🇺🇸San Antonio, Texas, United States