| Trial ID: | L1987 |
| Source ID: | NCT06435676
|
| Associated Drug: |
Hrs9531
|
| Title: |
A Study of Single and Multiple Doses HRS9531 Tablets in Healthy Subjects
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Overweight or Obesity; Type 2 Diabetes
|
| Interventions: |
DRUG: HRS9531|DRUG: Placebo|DRUG: HRS9531|DRUG: Placebo
|
| Outcome Measures: |
Primary: SAD Stage: Number of Adverse Events, 36 days|MAD Stage: Number of Adverse Events, 63 days | Secondary: Plasma Concentration-Time to Peak (Tmax) of HRS9531, Tmax of a single dose of HRS9531 tablets, 36 days|Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531, AUC of a single dose of HRS9531 tablets, 36 days|Immunogenicity qualitative, anti-HRS9531 antibody, 36 days|Plasma Concentration-Time to Peak (Tmax) of HRS9531, Tmax of multiple dose of HRS9531 tablets, 63 days|Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531, AUC of multiple dose of HRS9531 tablets, 63 days|Glucose, fasting plasma glucose, 35 days|Immunogenicity qualitative, anti-HRS9531 antibody, 63 days
|
| Sponsor/Collaborators: |
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
92
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-06-04
|
| Completion Date: |
2024-09-30
|
| Results First Posted: |
|
| Last Update Posted: |
2024-06-21
|
| Locations: |
The Second Hospital Of Anhui medical University, Hefei, Anhui, 230601, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06435676
|
