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Completed

NCT Number: NCT04965337

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

This is a Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Single Center Bridging Study to Evaluate Safety, Tolerability and Pharmacokinetics of ASC42 in Chinese Healthy Subjects.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Xiangya Boai Rehabilitation Hospital

Changsha, Hunan, 410008, China

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 volunteers aged 18-55 years.
  • 19kg/m2 ≤ BMI <24kg/m2.

Key Exclusion Criteria:

  • A positive HBsAg, HCV Ab and/or HIV Ab.
  • Pancreatic injury or pancreatitis.
  • History of organ transplantation, including bone marrow transplantation.

Treatment and study plan

ASC42

Drug

ASC42 tablet administered orally

Placebo

Drug

Matching placebo administered orally

Primary outcomes

  1. AUC of ASC42

    Time frame: Up to 4 days

    Evaluate the Area under the plasma concentration versus time curve.

  2. Cmax of ASC42

    Time frame: Up to 4 days

    Evaluate the Peak Plasma Concentration.

Secondary outcomes

  1. t1/2 of ASC42

    Time frame: Up to 4 days

    Evaluate the Terminal-Phase Half-Life.

  2. CL/F of ASC42

    Time frame: Up to 4 days

    Evaluate the Apparent Systemic Clearance.

  3. Vd/F of ASC42

    Time frame: Up to 4 days

    Evaluate the Apparent Volume of Distribution.

  4. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: Up to 7 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 7 days.

Sponsors and collaborators

Lead sponsor

Ascletis Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 16, 2021
Registry last updated
Jun 30, 2022

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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