A Study of the Relative Bioavailability of ASC41 in Healthy Subjects

NCT04527250 | Completed Phase 1

• 1 other identifier: ASC-ASC41-I-CTP-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Cmax of ASC41

  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

  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

  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

  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

  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.

Study Arms (10)

Experimental:1mg

EXPERIMENTAL

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

Drug: ASC41

Experimental:2mg

EXPERIMENTAL

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

Experimental:5mg

EXPERIMENTAL

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

Drug: ASC41

Experimental:10mg

EXPERIMENTAL

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

Drug: ASC41

Experimental:20mg

EXPERIMENTAL

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

Drug: ASC41

Placebo:1mg

PLACEBO COMPARATOR

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

Placebo:2mg

PLACEBO COMPARATOR

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

Placebo:5mg

PLACEBO COMPARATOR

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

Placebo:10mg

PLACEBO COMPARATOR

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

Drug: ASC41 placebo

Placebo:20mg

PLACEBO COMPARATOR

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

Drug: ASC41 placebo

Interventions

ASC41 DRUG

ASC41,1mg/table;5mg/table

Experimental:10mg; Experimental:1mg; Experimental:20mg; Experimental:2mg; Experimental:5mg

ASC41 placebo DRUG

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

Placebo:10mg; Placebo:1mg; Placebo:20mg; Placebo:2mg; Placebo:5mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Age 18-45 (including boundary value). 2. Male weight ≥ 50kg, female weight ≥ 45kg;BMI ranges from 19 to 30kg/m2 (boundary value included).
• \. 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.
• \. The pregnancy test of female subjects during the screening period is negative.
• \. During the screening period, fasting low-density lipoprotein cholesterol (110mg/dl \< fasting (LDL-C) \< 190mg/ dL.
• \. Those who voluntarily sign the informed consent.

You may not qualify if:

• \. 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.
• \. Previous liver disease, or ALT, ASL and direct bilirubin in screening period exceed the normal range.
• \. Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (HCV Ab), HIV antibody (HIV Ab) and syphilis antibody are tested positive.
• \. 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.
• \. 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.
• \. Ingesting chocolate, any food or drink containing caffeine or xanthine in the 24 hours prior to taking the study drug.
• \. Patients who had donated blood or lost blood of more than 400ml within 3 months before taking the study drug.
• \. Those who have participated in other clinical trials and received study drug treatment within 3 months before taking study drug.
• \. In addition to the above, the researchers judge that the participants are not suitable to participate in this clinical trial.

Sponsors & Collaborators

• Ascletis Pharmaceuticals Co., Ltd.: lead
• Hunan Provincial People's Hospital: collaborator

Study Sites (1)

Hunan provincial people's hospital

Changsha, Hunan, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2020
• First Posted: August 26, 2020
• Study Start: September 16, 2020
• Primary Completion: December 18, 2020
• Study Completion: December 30, 2020
• Last Updated: August 20, 2021

Record last verified: 2021-08

Locations

CN (1)