A Study of the Relative Bioavailability of ASC41 in Healthy Subjects

• ClinicalTrials.gov Identifier: NCT04527250
• Recruitment Status: Completed
• First Posted: August 26, 2020
• Last Update Posted: August 20, 2021
• Sponsor: Ascletis Pharmaceuticals Co., Ltd.
• Collaborator: Hunan Provincial People's Hospital
• Information provided by (Responsible Party): Ascletis Pharmaceuticals Co., Ltd.

Tracking Information

• First Submitted Date: August 23, 2020
• First Posted Date: August 26, 2020
• Last Update Posted Date: August 20, 2021
• Actual Study Start Date: September 16, 2020
• Actual Primary Completion Date: December 18, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 23, 2020)

Evaluation of the safety and tolerability of ASC41 in healthy volunteers [ Time Frame: Up to 32 days ]

Evaluation of the safety and tolerability of ASC41 in healthy volunteers

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 23, 2020)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of the Relative Bioavailability of ASC41 in Healthy Subjects
• Official Title: Comparison of the Pharmacokinetic Parameters of ASC41, a Randomized, Double-blind, Placebo-controlled in Healthy Subjects After Single and Multiple Doses
• 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.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Treatment
• Condition: Healthy

Intervention

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

Study Arms

• 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.
  Intervention: Drug: ASC41
• 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.
  Intervention: Drug: ASC41
• 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.
  Intervention: Drug: ASC41
• Experimental: Experimental:10mg
  ASC41 two tablets (10mg) single oral dose at Day 1.
  Intervention: Drug: ASC41
• Experimental: Experimental:20mg
  ASC41 four tablets (20mg) single oral dose at Day 1.
  Intervention: Drug: ASC41
• 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.
  Intervention: Drug: ASC41 placebo
• 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.
  Intervention: Drug: ASC41 placebo
• 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.
  Intervention: Drug: ASC41 placebo
• Placebo Comparator: Placebo:10mg
  ASC41 placebo two tablets (10mg) single oral dose at Day 1.
  Intervention: Drug: ASC41 placebo
• Placebo Comparator: Placebo:20mg
  ASC41 placebo four tablets (20mg) single oral dose at Day 1.
  Intervention: Drug: ASC41 placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 19, 2021): 60
• Original Estimated Enrollment (submitted: August 23, 2020): 65
• Actual Study Completion Date: December 30, 2020
• Actual Primary Completion Date: December 18, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04527250
• Other Study ID Numbers: ASC-ASC41-I-CTP-02
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Ascletis Pharmaceuticals Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Ascletis Pharmaceuticals Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Hunan Provincial People's Hospital
• Investigators: Not Provided
• PRS Account: Ascletis Pharmaceuticals Co., Ltd.
• Verification Date: August 2021