| Trial ID: | L3017 |
| Source ID: | NCT05943886
|
| Associated Drug: |
Hec88473 Injection
|
| Title: |
A Phase 1 Study of HEC88473 Injection in Healthy Subjects, Obese Subjects and T2DM Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Healthy Subjects|Obesity|T2DM (Type 2 Diabetes Mellitus)
|
| Interventions: |
DRUG: HEC88473 injection|DRUG: Placebo
|
| Outcome Measures: |
Primary: Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after a single dose of HEC88473, Adverse Events (AEs), Baseline to day 15|Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after multiple dose of HEC88473, Adverse Events (AEs), Baseline to day 43|Cmax, Maximum observed serum concentration of HEC88473, Predose and postdose 4、8、10、12、14、24、48、72、96、168、216、336 hours|AUC, Area under the serum concentration-time curve (AUC), Predose and postdose 4、8、10、12、14、24、48、72、96、168、216、336 hours | Secondary: OGTT, Oral glucose tolerance test, Day-1, Day3 and Day 7|Change from baseline of Adiponectin at day 38, Adiponectin, Baseline to day 38|Fasting lipid concentration, Fasting lipid concentration, Baseline to day 43|Change from baseline of HbA1c at day 38, HbA1c, Baseline to day 38|Assessment of the incidence of anti drug antibodies (ADA) developed against HEC88473 after dosing, anti drug antibodies (ADA), Baseline to day 43
|
| Sponsor/Collaborators: |
Sponsor: Dongguan HEC Biopharmaceutical R&D Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
164
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2021-08-11
|
| Completion Date: |
2023-02-17
|
| Results First Posted: |
|
| Last Update Posted: |
2023-07-17
|
| Locations: |
The First Hospital of Jilin University, Changchun, Jilin, 130000, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05943886
|
