| Trial ID: | L0351 |
| Source ID: | NCT04389775
|
| Associated Drug: |
XW003
|
| Title: |
To Evaluate the Safety, Tolerability, PK, and PD of XW003 Injection in Healthy Adult Participants
|
| Acronym: |
XW003
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Type 2 Diabetes Mellitus|Obesity|Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: Cohort A|Drug: Placebo A|Drug: Cohort B|Drug: Placebo B
|
| Outcome Measures: |
Number of treatment emergent adverse events (TEAEs)|Maximum observed XW003 plasma concentration|Time of the maximum observed XW003 plasma concentration|Area under the XW003 plasma concentration-time curve|Apparent terminal half-life of XW003|Apparent terminal elimination rate constant of XW003|Apparent total clearance of XW003|Apparent volume of distribution of XW003|Change from Baseline in body weight|Change from Baseline in fasting plasma glucose|Change from Baseline in plasma insulin and pro-insulin|Change from Baseline in plasma C-peptide|Change from Baseline in plasma glucagon|Change from Baseline in plasma lipids (triglyceride, low-density lipoprotein [LDL], and high-density lipoprotein [HDL])|Incidence of anti-XW003 antibodies at end of study|Area under the plasma concentration curve time zero to the last detectable time point before second dose|Area under the plasma concentration curve over a dosing interval after first dosing|Maximum plasma concentration after first dosing|Time to maximum plasma concentration after first dosing|Terminal phase elimination rate-constant after first dosing|Terminal phase elimination half-life after first dosing|Clearance after last dosing|Volume of distribution after last dosing|AUC accumulation ratio constant|Trough plasma XW003 concentrations before next dosing (Day 1 to last dosing)
|
| Sponsor/Collaborators: |
Sciwind Biosciences APAC CO Pty. Ltd.|Hangzhou Sciwind Biosciences Co., Ltd.
|
| Gender: |
All
|
| Age: |
18 Years to 55 Years ?? (Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
64
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
|
| Start Date: |
March 29, 2020
|
| Completion Date: |
September 29, 2021
|
| Results First Posted: |
--
|
| Last Update Posted: |
October 28, 2021
|
| Locations: |
Nucleus Network Pty Ltd, Melbourne, Victoria, Australia
|
| URL: |
https://ClinicalTrials.gov/show/NCT04389775
|
