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Trial record 1 of 1 for:    NCT04527250
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A Study of the Relative Bioavailability of ASC41 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT04527250
Recruitment Status : Completed
First Posted : August 26, 2020
Last Update Posted : August 20, 2021
Sponsor:
Collaborator:
Hunan Provincial People's Hospital
Information provided by (Responsible Party):
Ascletis Pharmaceuticals Co., Ltd.

Brief Summary:
The objective of this study is to compare the pharmacokinetic parameters of ASC41 in healthy subjects after single and multiple oral dosing.

Condition or disease Intervention/treatment Phase
Healthy Drug: ASC41 Drug: ASC41 placebo Phase 1

Detailed Description:
The purpose of this study was to evaluate the tolerability, safety pharmacokinetics and pharmacodynamic (biomarkers) of ASC41 tables in a randomized, double-blind, placebo-controlled single- and multiple-dose phase I clinical trial in healthy subjects the study. The effects of ASC41 on LDL-C and other lipid parameters (TG, TC, HDL-C, etc.) will be observed after repeated administration of ASC41 in healthy subjects.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Comparison of the Pharmacokinetic Parameters of ASC41, a Randomized, Double-blind, Placebo-controlled in Healthy Subjects After Single and Multiple Doses
Actual Study Start Date : September 16, 2020
Actual Primary Completion Date : December 18, 2020
Actual Study Completion Date : December 30, 2020

Arm Intervention/treatment
Experimental: Experimental:1mg
ASC41 one tablet (1mg) single oral dose at Day 1 and once daily for 14 days from Day 14 to Day 27.
Drug: ASC41
ASC41,1mg/table;5mg/table

Experimental: Experimental:2mg
ASC41 two tablets (2mg) single oral dose at Day 1 and two tablets daily for 14 days from Day 14 to Day 27.
Drug: ASC41
ASC41,1mg/table;5mg/table

Experimental: Experimental:5mg
ASC41 one tablet (5mg) single oral dose at Day 1 and once daily for 14 days from Day 14 to Day 27.
Drug: ASC41
ASC41,1mg/table;5mg/table

Experimental: Experimental:10mg
ASC41 two tablets (10mg) single oral dose at Day 1.
Drug: ASC41
ASC41,1mg/table;5mg/table

Experimental: Experimental:20mg
ASC41 four tablets (20mg) single oral dose at Day 1.
Drug: ASC41
ASC41,1mg/table;5mg/table

Placebo Comparator: Placebo:1mg
ASC41 placebo one tablet (1mg) single oral dose at Day 1 and once daily for 14 days from Day 14 to Day 27.
Drug: ASC41 placebo
ASC41 placebo,1mg/table;5mg/table

Placebo Comparator: Placebo:2mg
ASC41 placebo two tablets (2mg) single oral dose at Day 1 and two tablets daily for 14 days from Day 14 to Day 27.
Drug: ASC41 placebo
ASC41 placebo,1mg/table;5mg/table

Placebo Comparator: Placebo:5mg
ASC41 placebo one tablet (5mg) single oral dose at Day 1 and once daily for 14 days from Day 14 to Day 27.
Drug: ASC41 placebo
ASC41 placebo,1mg/table;5mg/table

Placebo Comparator: Placebo:10mg
ASC41 placebo two tablets (10mg) single oral dose at Day 1.
Drug: ASC41 placebo
ASC41 placebo,1mg/table;5mg/table

Placebo Comparator: Placebo:20mg
ASC41 placebo four tablets (20mg) single oral dose at Day 1.
Drug: ASC41 placebo
ASC41 placebo,1mg/table;5mg/table




Primary Outcome Measures :
  1. Evaluation of the safety and tolerability of ASC41 in healthy volunteers [ Time Frame: Up to 32 days ]
    Evaluation of the safety and tolerability of ASC41 in healthy volunteers


Secondary Outcome Measures :
  1. Cmax of ASC41 [ Time Frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days. ]
    Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC41 administered to Chinese healthy volunteers.

  2. Tmax of ASC41 [ Time Frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days. ]
    Evaluate the Time to reach the maximum plasma concentration after single and multiple oral doses of ASC41 administered to Chinese healthy volunteers.

  3. AUC of ASC41 [ Time Frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days. ]
    Evaluate the Area under the plasma concentration versus time curve after single and multiple oral doses of ASC41 administered to Chinese healthy volunteers.

  4. t1/2 of ASC41 [ Time Frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days. ]
    Evaluate the Terminal-Phase Half-Life after single and multiple oral doses of ASC41 administered to Chinese healthy volunteers volunteers.

  5. CL/F of ASC41 [ Time Frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days. ]
    Evaluate the Apparent Systemic Clearance after single and multiple oral dose of ASC41 administered to Chinese healthy volunteers.

  6. Vd/F of ASC41 [ Time Frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days. ]
    Evaluate the Apparent Volume of Distribution after single and multiple oral dose of ASC41 administered to Chinese healthy volunteers.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1. Age 18-45 (including boundary value). 2. Male weight ≥ 50kg, female weight ≥ 45kg;BMI ranges from 19 to 30kg/m2 (boundary value included).

    3. She is of childbearing potential and is non-pregnant and willing to use adequate contraception from screening (within 30days from the first administration)until one month after the End of Study visit.

    4. The pregnancy test of female subjects during the screening period is negative.

    5. During the screening period, fasting low-density lipoprotein cholesterol (110mg/dl < fasting (LDL-C) < 190mg/ dL.

    6. Those who voluntarily sign the informed consent.

Exclusion Criteria:

  • 1. Patients with a history of thyroid disease or intolerance to beta blockers or abnormal thyroid function indicators during screening; 2. Previous history of fainting, fainting needle or fainting blood for unknown reasons.

    3. Previous liver disease, or ALT, ASL and direct bilirubin in screening period exceed the normal range.

    4. Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (HCV Ab), HIV antibody (HIV Ab) and syphilis antibody are tested positive.

    5. People who have taken special diet (including carambola, dragon fruit, mango, grapefruit, orange, etc.) or drunk alcohol, or had strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, and excretion within 2 weeks before taking the study drug.

    6. Heavy smokers (14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine;Smoking daily ≥ 5 sticks) and no smoking or alcohol prohibition during the study period.

    7. Ingesting chocolate, any food or drink containing caffeine or xanthine in the 24 hours prior to taking the study drug.

    8. Patients who had donated blood or lost blood of more than 400ml within 3 months before taking the study drug.

    9. Those who have participated in other clinical trials and received study drug treatment within 3 months before taking study drug.

    10. In addition to the above, the researchers judge that the participants are not suitable to participate in this clinical trial.


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): NCT04527250


Locations
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China, Hunan
Hunan provincial people's hospital
Changsha, Hunan, China
Sponsors and Collaborators
Ascletis Pharmaceuticals Co., Ltd.
Hunan Provincial People's Hospital
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Responsible Party: Ascletis Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT04527250    
Other Study ID Numbers: ASC-ASC41-I-CTP-02
First Posted: August 26, 2020    Key Record Dates
Last Update Posted: August 20, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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