A Study of the Relative Bioavailability of ASC41 in Healthy Subjects

Ascletis

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ASC41; Drug: ASC41 placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04527250

ASC-ASC41-I-CTP-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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).

  2. 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.

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

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

  5. 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.

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

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

  4. 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.

  5. 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.

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

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

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 10 patient groups, including a placebo group

Experimental:1mg

Experimental group

Description:

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

Treatment:

Drug: ASC41

Experimental:2mg

Experimental group

Description:

ASC41 two tablets (2mg) single oral dose at Day 1 and two tablets daily for 14 days from Day 14 to Day 27.

Treatment:

Drug: ASC41

Experimental:5mg

Experimental group

Description:

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

Treatment:

Drug: ASC41

Experimental:10mg

Experimental group

Description:

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

Treatment:

Drug: ASC41

Experimental:20mg

Experimental group

Description:

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

Treatment:

Drug: ASC41

Placebo:1mg

Placebo Comparator group

Description:

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

Treatment:

Drug: ASC41 placebo

Placebo:2mg

Placebo Comparator group

Description:

ASC41 placebo two tablets (2mg) single oral dose at Day 1 and two tablets daily for 14 days from Day 14 to Day 27.

Treatment:

Drug: ASC41 placebo

Placebo:5mg

Placebo Comparator group

Description:

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

Treatment:

Drug: ASC41 placebo

Placebo:10mg

Placebo Comparator group

Description:

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

Treatment:

Drug: ASC41 placebo

Placebo:20mg

Placebo Comparator group

Description:

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

Treatment:

Drug: ASC41 placebo