Overweight and Obesity Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Phase Ib Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics (Biomarkers) of ASC41 Tables in Overweight and Obese Subjects
Verified date | December 2020 |
Source | Gannex Pharma Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of this study is to evaluate the safety, tolerability and compare the pharmacokinetic parameters of ASC41, a THR beta agonist tables in overweight and obese subjects who have elevated LDL-C .
Status | Completed |
Enrollment | 20 |
Est. completion date | February 7, 2021 |
Est. primary completion date | January 19, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 59 Years |
Eligibility | Key Inclusion Criteria: - 23kg/m2 = BMI <40kg/m2. Key Exclusion Criteria: - A history of thyroid disease. - A positive HBsAg, HCV Ab and/or HIV Ab. |
Country | Name | City | State |
---|---|---|---|
China | Hunan provincial people's hospital | Changsha | Hunan |
Lead Sponsor | Collaborator |
---|---|
Gannex Pharma Co., Ltd. | Hunan Provincial People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation and/or dose reductions, and AE of special interest, from baseline up to 28 days | Up to 28 days | |
Secondary | AUC of ASC41 | Evaluate the Area under the plasma concentration versus time curve after multiple oral doses of ASC41 tablets. | Up to 28 days | |
Secondary | Cmax of ASC41 | Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC41 tablets. | Up to 28 days | |
Secondary | t1/2 of ASC41 | Evaluate the Terminal-Phase Half-Life after single and multiple oral doses of ASC41 tables. | Up to 28 days | |
Secondary | CL/F of ASC41 | Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables. | Up to 28 days | |
Secondary | Vd/F of ASC41 | Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables. | Up to 28 days | |
Secondary | Tmax of ASC41 | Evaluate the Time to reach the maximum plasma concentration after multiple oral doses of ASC41 tables. | Up to 28 days | |
Secondary | LDL-C and other lipid parameters | To evaluate the effect of multiple doses of ASC41 tablets on LDL-C and other lipid parameters (TG, TC, HDL-C, etc.) . | Up to 28 days |
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