Healthy
Conditions
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.
Interventions
DRUGASC42
Oral tablets
DRUGPlacebo
Oral tablets
Sponsors
Gannex Pharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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) |
| 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. |
Countries
United States
Outcome results
None listed