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

• ClinicalTrials.gov Identifier: NCT04679129
• Recruitment Status: Completed
• First Posted: December 22, 2020
• Last Update Posted: June 28, 2021
• Sponsor: Gannex Pharma Co., Ltd.
• Information provided by (Responsible Party): Gannex Pharma Co., Ltd.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: ASC42; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: November 30, 2020
• Actual Primary Completion Date: May 3, 2021
• Actual Study Completion Date: June 3, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Single Ascending Dose-ASC42; ASC42 tablet，Dose 1，Dose 2，Dose 3，Dose 4，and Dose 5, single dose administration	Drug: ASC42; Oral tablets
Experimental: Multiple Ascending Dose-ASC42; ASC42 tablet, Dose 1，Dose 2，Dose 3，q.d.×14 days	Drug: ASC42; Oral tablets
Placebo Comparator: Single Ascending Dose-Placebo; Placebo tablet，Dose 1，Dose 2，Dose 3，Dose 4，and Dose 5, single dose administration	Drug: Placebo; Oral tablets
Placebo Comparator: Multiple Ascending Dose-Placebo; Placebo tablet，Dose 1，Dose 2，Dose 3，q.d.×14 days	Drug: Placebo; Oral tablets

Outcome Measures

Primary Outcome Measures :

1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 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 :

1. AUC of ASC42 [ Time Frame: 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.
2. Cmax of ASC42 [ Time Frame: 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.
3. t1/2 of ASC42 [ Time Frame: 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.
4. CL/F of ASC42 [ Time Frame: 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.
5. Vd/F of ASC42 [ Time Frame: 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.
6. Tmax of ASC42 [ Time Frame: 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.
7. C4 [ Time Frame: 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)
8. FGF19 [ Time Frame: 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Texas

ICON early Phase Services LLC

San Antonio, Texas, United States, 78209

Sponsors and Collaborators

Gannex Pharma Co., Ltd.

More Information

• Responsible Party: Gannex Pharma Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04679129
• Other Study ID Numbers: ASC42-I-CTP-01
• First Posted: December 22, 2020
• Last Update Posted: June 28, 2021
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No