A Study of the Relative Bioavailability of ASC41 in Healthy Subjects

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04527250
• Other study ID #: ASC-ASC41-I-CTP-02
• Status: Completed
• Phase: Phase 1
• Start date: September 16, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: August 2021
• Source: Ascletis Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2020
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ASC41
ASC41,1mg/table;5mg/table
• ASC41 placebo
ASC41 placebo,1mg/table;5mg/table

Locations

Country	Name	City	State
China	Hunan provincial people's hospital	Changsha	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Ascletis Pharmaceuticals Co., Ltd.	Hunan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.