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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 : October 19, 2021
Sponsor:
Information provided by (Responsible Party):
Ascletis Pharmaceuticals Co., Ltd.

Tracking Information
First Submitted Date  ICMJE July 7, 2021
First Posted Date  ICMJE July 16, 2021
Last Update Posted Date October 19, 2021
Actual Study Start Date  ICMJE July 11, 2021
Actual Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2021)
  • AUC of ASC42 [ Time Frame: Up to 4 days ]
    Evaluate the Area under the plasma concentration versus time curve.
  • Cmax of ASC42 [ Time Frame: Up to 4 days ]
    Evaluate the Peak Plasma Concentration.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2021)
  • t1/2 of ASC42 [ Time Frame: Up to 4 days ]
    Evaluate the Terminal-Phase Half-Life.
  • CL/F of ASC42 [ Time Frame: Up to 4 days ]
    Evaluate the Apparent Systemic Clearance.
  • Vd/F of ASC42 [ Time Frame: Up to 4 days ]
    Evaluate the Apparent Volume of Distribution.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2021)
  • t1/2 of ASC42 [ Time Frame: Up to 4 days ]
    Evaluate the Terminal-Phase Half-Life.
  • CL/F of ASC42 [ Time Frame: Up to 4 days ]
    Evaluate the Apparent Systemic Clearance.
  • Vd/F of ASC41 [ Time Frame: Up to 4 days ]
    Evaluate the Apparent Volume of Distribution.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Safety, Tolerability and Pharmacokinetics of ASC42 in Chinese Healthy Subjects
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: ASC42
    ASC42 tablet administered orally
  • Drug: Placebo
    Matching placebo administered orally
Study Arms  ICMJE
  • Experimental: ASC42 Dose A
    ASC42 tablet Dose A, once daily
    Intervention: Drug: ASC42
  • Placebo Comparator: Placebo Dose A
    Placebo Comparator: Single dose of matched placebo to ASC42 tablet Dose A, once daily
    Intervention: Drug: Placebo
  • Experimental: ASC42 Dose B
    ASC42 tablet Dose B, once daily
    Intervention: Drug: ASC42
  • Placebo Comparator: Placebo Dose B
    Placebo Comparator: Single dose of matched placebo to ASC42 tablet Dose A, once daily
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 7, 2021)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 20, 2022
Actual Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04965337
Other Study ID Numbers  ICMJE ASC42-102
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ascletis Pharmaceuticals Co., Ltd.
Study Sponsor  ICMJE Ascletis Pharmaceuticals Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ascletis Pharmaceuticals Co., Ltd.
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP