A Study of the Relative Bioavailability of ASC41 in Healthy Subjects

NCT ID: NCT04527250

Last Updated: 2021-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-16
• Study Completion Date: 2020-12-30

Brief Summary

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

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental:1mg

ASC41 one tablet (1mg) single oral dose at Day 1 and once daily for 14 days from Day 14 to Day 27.

Group Type: EXPERIMENTAL

ASC41

Intervention Type: DRUG

ASC41,1mg/table;5mg/table

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.

Group Type: EXPERIMENTAL

ASC41

Intervention Type: DRUG

ASC41,1mg/table;5mg/table

Experimental:5mg

ASC41 one tablet (5mg) single oral dose at Day 1 and once daily for 14 days from Day 14 to Day 27.

Group Type: EXPERIMENTAL

ASC41

Intervention Type: DRUG

ASC41,1mg/table;5mg/table

Experimental:10mg

ASC41 two tablets (10mg) single oral dose at Day 1.

Group Type: EXPERIMENTAL

ASC41

Intervention Type: DRUG

ASC41,1mg/table;5mg/table

Experimental:20mg

ASC41 four tablets (20mg) single oral dose at Day 1.

Group Type: EXPERIMENTAL

ASC41

Intervention Type: DRUG

ASC41,1mg/table;5mg/table

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.

Group Type: PLACEBO_COMPARATOR

ASC41 placebo

Intervention Type: DRUG

ASC41 placebo,1mg/table;5mg/table

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.

Group Type: PLACEBO_COMPARATOR

ASC41 placebo

Intervention Type: DRUG

ASC41 placebo,1mg/table;5mg/table

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.

Group Type: PLACEBO_COMPARATOR

ASC41 placebo

Intervention Type: DRUG

ASC41 placebo,1mg/table;5mg/table

Placebo:10mg

ASC41 placebo two tablets (10mg) single oral dose at Day 1.

Group Type: PLACEBO_COMPARATOR

ASC41 placebo

Intervention Type: DRUG

ASC41 placebo,1mg/table;5mg/table

Placebo:20mg

ASC41 placebo four tablets (20mg) single oral dose at Day 1.

Group Type: PLACEBO_COMPARATOR

ASC41 placebo

Intervention Type: DRUG

ASC41 placebo,1mg/table;5mg/table

Interventions

ASC41

ASC41,1mg/table;5mg/table

Intervention Type: DRUG

ASC41 placebo

ASC41 placebo,1mg/table;5mg/table

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hunan Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Ascletis Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hunan provincial people's hospital

Changsha, Hunan, China

Countries

China

Other Identifiers

ASC-ASC41-I-CTP-02

Identifier Type: -

Identifier Source: org_study_id