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Trial record 1 of 1 for:    NCT04679129
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Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of ASC42 in Healthy Subjects

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


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

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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

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




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)



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04679129


Locations
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United States, Texas
ICON early Phase Services LLC
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Gannex Pharma Co., Ltd.
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Responsible Party: Gannex Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT04679129    
Other Study ID Numbers: ASC42-I-CTP-01
First Posted: December 22, 2020    Key Record Dates
Last Update Posted: June 28, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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