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OpenTrials
Completed

NCT Number: NCT04679129

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

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON early Phase Services LLC

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASC42

Drug

Oral tablets

Placebo

Drug

Oral tablets

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Gannex Pharma Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 22, 2020
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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