| Trial ID: | L6544 |
| Source ID: | NCT06819488
|
| Associated Drug: |
[14c]Hrs-7535
|
| Title: |
A Clinical Study of Mass Balance of [14C]HRS-7535
|
| Acronym: |
|
| Status: |
NOT_YET_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus|Weight Loss
|
| Interventions: |
DRUG: [14C]HRS-7535
|
| Outcome Measures: |
Primary: The time of maximum observed concentration (Tmax), 0-120 hours.|The maximum observed concentration (Cmax), 0-120 hours.|The terminal half-life (t1/2), 0-120 hours.|The total body clearance for extravascular administration (CL/F), 0-120 hours.|The total radioactivity ratio for blood, 0-96 hours.|The total radioactivity ratio for plasma, 0-96 hours. | Secondary: Adverse events (AEs), 0-11 days.|Serious adverse events (AEs), 0-11 days.
|
| Sponsor/Collaborators: |
Sponsor: Shandong Suncadia Medicine Co., Ltd.
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
6
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2025-02
|
| Completion Date: |
2025-03
|
| Results First Posted: |
|
| Last Update Posted: |
2025-02-11
|
| Locations: |
The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210029, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06819488
|
