Study to Evaluate Safety, Tolerability and Pharmacokinetics of ASC42 in Chinese Healthy Subjects
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ClinicalTrials.gov Identifier: NCT04965337 |
Recruitment Status :
Completed
First Posted : July 16, 2021
Last Update Posted : June 30, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: ASC42 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Other |
Official Title: | A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Single Center Bridging Study to Evaluate Safety, Tolerability and Pharmacokinetics of ASC42 in Chinese Healthy Subjects |
Actual Study Start Date : | July 11, 2021 |
Actual Primary Completion Date : | August 1, 2021 |
Actual Study Completion Date : | August 1, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: ASC42 Dose A
ASC42 tablet Dose A, once daily
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Drug: ASC42
ASC42 tablet administered orally |
Placebo Comparator: Placebo Dose A
Placebo Comparator: Single dose of matched placebo to ASC42 tablet Dose A, once daily
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Drug: Placebo
Matching placebo administered orally |
Experimental: ASC42 Dose B
ASC42 tablet Dose B, once daily
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Drug: ASC42
ASC42 tablet administered orally |
Placebo Comparator: Placebo Dose B
Placebo Comparator: Single dose of matched placebo to ASC42 tablet Dose A, once daily
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Drug: Placebo
Matching placebo administered orally |
- AUC of ASC42 [ Time Frame: Up to 4 days ]Evaluate the Area under the plasma concentration versus time curve.
- Cmax of ASC42 [ Time Frame: Up to 4 days ]Evaluate the Peak Plasma Concentration.
- t1/2 of ASC42 [ Time Frame: Up to 4 days ]Evaluate the Terminal-Phase Half-Life.
- CL/F of ASC42 [ Time Frame: Up to 4 days ]Evaluate the Apparent Systemic Clearance.
- Vd/F of ASC42 [ Time Frame: Up to 4 days ]Evaluate the Apparent Volume of Distribution.
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Up to 7 days ]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 7 days.

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Key Inclusion Criteria:
- Healthy male and female volunteers aged 18-55 years.
- 19kg/m2 ≤ BMI <24kg/m2.
Key Exclusion Criteria:
- A positive HBsAg, HCV Ab and/or HIV Ab.
- Pancreatic injury or pancreatitis.
- History of organ transplantation, including bone marrow transplantation.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04965337
China, Hunan | |
Xiangya Boai Rehabilitation Hospital | |
Changsha, Hunan, China, 410008 |
Responsible Party: | Ascletis Pharmaceuticals Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT04965337 |
Other Study ID Numbers: |
ASC42-102 |
First Posted: | July 16, 2021 Key Record Dates |
Last Update Posted: | June 30, 2022 |
Last Verified: | June 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Healthy Subjects ASC42 FXR agonist |