| Trial ID: | L7342 |
| Source ID: | NCT05152277
|
| Associated Drug: |
Hrs9531
|
| Title: |
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS9531 in Healthy Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: HRS9531|OTHER: placebo|DRUG: HRS9531|OTHER: placebo
|
| Outcome Measures: |
Primary: Number of Adverse Events, A summary of adverse events, including Serious Adverse Events(SAEs), Start of Treatment to end of study (approximately 7 weeks or 9 weeks) | Secondary: Area under the plasma concentration-time curve (AUC) of HRS9531, AUC of HRS9531 after single subcutaneous injection, Start of Treatment to end of study (approximately 7 weeks)|Immunogenicity qualitative, anti-HRS9531 antibody, Start of Treatment to end of study (approximately 7 weeks)|AUC of HRS9531, AUC of HRS9531 after multiple subcutaneous injections, Start of Treatment to end of study (approximately 9 weeks)|Immunogenicity qualitative, anti-HRS9531 antibody, Start of Treatment to end of study (approximately 9 weeks)|Glucose concentration, fasting plasma glucose, Start of Treatment to end of study (approximately 9 weeks)
|
| Sponsor/Collaborators: |
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
90
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2021-12-06
|
| Completion Date: |
2022-08-24
|
| Results First Posted: |
|
| Last Update Posted: |
2022-09-19
|
| Locations: |
Jinan Central Hospital, Jinan, Shandong, 250013, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05152277
|
