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

• Sponsor: Gannex Pharma Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04679129
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 4
• Actual Duration (Months): 6.1
• Patients Per Site Per Month: 10.5

Study Details

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
• 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: Nov 30, 2020
• Actual Primary Completion Date: May 3, 2021
• Actual Study Completion Date: Jun 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] [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 [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 [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 [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 [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 [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 [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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

	Site	City	State	Country	Postal Code
1	ICON early Phase Services LLC	San Antonio	Texas	United States	78209

Sponsors and Collaborators

• Gannex Pharma Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gannex Pharma Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04679129
• Other Study ID Numbers: ASC42-I-CTP-01
• First Posted: Dec 22, 2020
• Last Update Posted: Jun 28, 2021
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 28, 2021