- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04965337
Study to Evaluate Safety, Tolerability and Pharmacokinetics of ASC42 in Chinese Healthy Subjects
June 28, 2022 updated by: Ascletis Pharmaceuticals Co., Ltd.
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
This is 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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410008
- Xiangya Boai Rehabilitation Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ASC42 Dose A
ASC42 tablet Dose A, once daily
|
ASC42 tablet administered orally
|
Placebo Comparator: Placebo Dose A
Placebo Comparator: Single dose of matched placebo to ASC42 tablet Dose A, once daily
|
Matching placebo administered orally
|
Experimental: ASC42 Dose B
ASC42 tablet Dose B, once daily
|
ASC42 tablet administered orally
|
Placebo Comparator: Placebo Dose B
Placebo Comparator: Single dose of matched placebo to ASC42 tablet Dose A, once daily
|
Matching placebo administered orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC of ASC42
Time Frame: Up to 4 days
|
Evaluate the Area under the plasma concentration versus time curve.
|
Up to 4 days
|
Cmax of ASC42
Time Frame: Up to 4 days
|
Evaluate the Peak Plasma Concentration.
|
Up to 4 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
t1/2 of ASC42
Time Frame: Up to 4 days
|
Evaluate the Terminal-Phase Half-Life.
|
Up to 4 days
|
CL/F of ASC42
Time Frame: Up to 4 days
|
Evaluate the Apparent Systemic Clearance.
|
Up to 4 days
|
Vd/F of ASC42
Time Frame: Up to 4 days
|
Evaluate the Apparent Volume of Distribution.
|
Up to 4 days
|
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.
|
Up to 7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 11, 2021
Primary Completion (Actual)
August 1, 2021
Study Completion (Actual)
August 1, 2021
Study Registration Dates
First Submitted
July 7, 2021
First Submitted That Met QC Criteria
July 7, 2021
First Posted (Actual)
July 16, 2021
Study Record Updates
Last Update Posted (Actual)
June 30, 2022
Last Update Submitted That Met QC Criteria
June 28, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ASC42-102
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States