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

Healthy Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Single Center Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics (Biomarkers) of ASC42 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04679129
• Other study ID #: ASC42-I-CTP-01
• Status: Completed
• Phase: Phase 1
• Start date: November 30, 2020
• Est. completion date: June 3, 2021

Study information

• Verified date: November 2020
• Source: Gannex Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 3, 2021
• Est. primary completion date: May 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ASC42
Oral tablets
• Placebo
Oral tablets

Locations

Country	Name	City	State
United States	ICON early Phase Services LLC	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Gannex Pharma Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	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	Up to 21 days
Secondary	AUC of ASC42	Evaluate the Area under the plasma concentration versus time curve after single and multiple oral doses of ASC42 administered to healthy volunteers.	On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.
Secondary	Cmax of ASC42	Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC42 administered to healthy volunteers.	On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.
Secondary	t1/2 of ASC42	Evaluate the Terminal-Phase Half-Life after single and multiple oral doses of ASC42 administered to healthy volunteers.	On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.
Secondary	CL/F of ASC42	Evaluate the Apparent Systemic Clearance after single and multiple oral dose of ASC42 administered to healthy volunteers.	On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.
Secondary	Vd/F of ASC42	Evaluate the Apparent Volume of Distribution after single and multiple oral dose of ASC42 administered to healthy volunteers.	On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.
Secondary	Tmax of ASC42	Evaluate the Time to reach the maximum plasma concentration after single single and multiple oral doses of ASC42 administered to healthy volunteers.	On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.
Secondary	C4	Bile acid precuisor:C4 (7ahydroxy-4-cholesten-3-one)	On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.
Secondary	FGF19	Bile acid precursor:FGF19 (Fibroblast growth factor 19)	On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.