A Study of the Relative Bioavailability of ASC41 in Healthy Subjects

Comparison of the Pharmacokinetic Parameters of ASC41, a Randomized, Double-blind, Placebo-controlled in Healthy Subjects After Single and Multiple Doses

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: ASC41; Drug: ASC41 placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • Hunan Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

10

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the safety and tolerability of ASC41 in healthy volunteers	Evaluation of the safety and tolerability of ASC41 in healthy volunteers	Up to 32 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of ASC41	Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC41 administered to Chinese healthy volunteers.	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.
Tmax of ASC41	Evaluate the Time to reach the maximum plasma concentration after single and multiple oral doses of ASC41 administered to Chinese healthy volunteers.	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.
AUC of ASC41	Evaluate the Area under the plasma concentration versus time curve after single and multiple oral doses of ASC41 administered to Chinese healthy volunteers.	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.
t1/2 of ASC41	Evaluate the Terminal-Phase Half-Life after single and multiple oral doses of ASC41 administered to Chinese healthy volunteers volunteers.	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.
CL/F of ASC41	Evaluate the Apparent Systemic Clearance after single and multiple oral dose of ASC41 administered to Chinese healthy volunteers.	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.
Vd/F of ASC41	Evaluate the Apparent Volume of Distribution after single and multiple oral dose of ASC41 administered to Chinese healthy volunteers.	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.

Collaborators and Investigators

• Sponsor: Ascletis Pharmaceuticals Co., Ltd.
• Collaborators: Hunan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2020
• Primary Completion (Actual): December 18, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: August 23, 2020
• First Submitted That Met QC Criteria: August 23, 2020
• First Posted (Actual): August 26, 2020

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: ASC-ASC41-I-CTP-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No