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

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ClinicalTrials.gov Identifier: NCT04965337
Recruitment Status : Active, not recruiting
First Posted : July 16, 2021
Last Update Posted : August 20, 2021
Sponsor:
Information provided by (Responsible Party):
Ascletis Pharmaceuticals Co., Ltd.

Study Description
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Brief Summary:
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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official 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
Actual Study Start Date : July 11, 2021
Actual Primary Completion Date : August 1, 2021
Estimated Study Completion Date : September 30, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: ASC42 Dose A
ASC42 tablet Dose A, once daily
 Drug: ASC42
ASC42 tablet administered orally
Placebo Comparator: Placebo Dose A
Placebo Comparator: Single dose of matched placebo to ASC42 tablet Dose A, once daily
 Drug: Placebo
Matching placebo administered orally
Experimental: ASC42 Dose B
ASC42 tablet Dose B, once daily
 Drug: ASC42
ASC42 tablet administered orally
Placebo Comparator: Placebo Dose B
Placebo Comparator: Single dose of matched placebo to ASC42 tablet Dose A, once daily
 Drug: Placebo
Matching placebo administered orally


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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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): NCT04965337


Locations
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China, Hunan
Xiangya Boai Rehabilitation Hospital
Changsha, Hunan, China, 410008
Sponsors and Collaborators
Ascletis Pharmaceuticals Co., Ltd.
More Information
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Responsible Party: Ascletis Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT04965337    
Other Study ID Numbers: ASC42-102
First Posted: July 16, 2021    Key Record Dates
Last Update Posted: August 20, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ascletis Pharmaceuticals Co., Ltd.:
Healthy Subjects
ASC42
FXR agonist