| Trial ID: | L6116 |
| Source ID: | NCT06506175
|
| Associated Drug: |
Hrs9531 Tablets
|
| Title: |
Investigation of Optimal Dosage Regimen for HRS9531 Tablets in Healthy Subjects
|
| Acronym: |
|
| Status: |
NOT_YET_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Overweight or Obese, Type 2 Diabetes
|
| Interventions: |
DRUG: HRS9531 tablets
|
| Outcome Measures: |
Primary: AUCtau, Area under the HRS9531 tablets concentration curve from time 0-24 hours after the 10th dosing, 0-24hrs after the 10th dosing | Secondary: Tmax, Time to maximum plasma concentration, First dose at day 1 and post-dose at day 10|Cmax, The maximum plasma concentration, First dose at day 1 and post-dose at day 10|t1/2, Terminal half-life, First dose at day 1 and post-dose at day 10|Incidence and severity of adverse events, Screening period up to Day 45|Anti-HRS9531 antibody, Before First dose at day 1 to Day 45
|
| Sponsor/Collaborators: |
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
144
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2024-08-05
|
| Completion Date: |
2024-11-30
|
| Results First Posted: |
|
| Last Update Posted: |
2024-07-17
|
| Locations: |
The affiliated hospital of Qingdao University, Qingdao, Shandong, 266000, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06506175
|
