| Trial ID: | L6537 |
| Source ID: | NCT05369078
|
| Associated Drug: |
Thr-1442 20mg Single Dose
|
| Title: |
Safety, Tolerance and Pharmacokinetics of THR-1442 in Chinese Healthy Subjects
|
| Acronym: |
|
| Status: |
UNKNOWN
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
T2DM (Type 2 Diabetes Mellitus)
|
| Interventions: |
DRUG: THR-1442 20mg Single dose|DRUG: THR-1442 20mg Multiple dose group
|
| Outcome Measures: |
Primary: Collect and evaluate TEAEs (including clinical AEs and Lab AEs) of THR-1442 in healthy subjects during study, Collect data(TEAEs including clinical AEs and lab AEs) on Day7 and Day14 to evaluate THR1442 safety and tolerability, Single dose：Baseline to day 7 ； Multiple dose：Baseline to Day14 | Secondary: Select and evaluate pharmacokinetic characteristics(AUC) of THR-1442 in healthy subjects during the study, Collect blood samples on Single dose part and multiple dose part to evaluate THR1442 PK parameters （AUC）, Single dose：Day1-Day7； Multiple dose：Day1- Day14|Select and evaluate pharmacokinetic characteristics(Cmax) of THR-1442 in healthy subjects during the study, Collect blood samples on Single dose part and multiple dose part to evaluate THR1442 PK parameters （Cmax）, Single dose：Day1-Day7； Multiple dose：Day1- Day14
|
| Sponsor/Collaborators: |
Sponsor: Newsoara Biopharma Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
16
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2021-12-01
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| Completion Date: |
2022-05-31
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| Results First Posted: |
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| Last Update Posted: |
2022-05-11
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| Locations: |
Hangzhou First People's hospital, Hangzhou, Zhejiang, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05369078
|
