Type 2 Diabetes
Conditions
Brief summary
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple subcutaneous injections of HRS9531 in healthy subjects.
Interventions
DRUGHRS9531
Administered SC once
OTHERplacebo
Administered SC once
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
HRS9531 compared with placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent; 2. Age 18-55 years on the date of signing informed consent (inclusive); 3. Body weight ≥50 kg, body mass index (BMI) within the range of 19.0-35.0 kg/m2 (inclusive); 4. Subjects with good general health, no clinically significant abnormalities.
Exclusion criteria
1. With previous major organ diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, are judged by researchers to be unsuitable for the study; 2. Had a severe trauma or major surgery within 6 months prior to screening, planned to undergo surgery during the trial period; 3. Participants in clinical trials of any drug or medical device in the 3 months prior to screening; 4. Blood donation history or blood loss ≥400 mL within 1 month before screening, or received blood transfusion within 2 months; 5. Allergic constitution includes severe drug allergy or history of drug allergy; 6. Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive; 7. Breast-feeding women; 8. The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events | Start of Treatment to end of study (approximately 7 weeks or 9 weeks) | A summary of adverse events, including Serious Adverse Events(SAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration-time curve (AUC) of HRS9531 | Start of Treatment to end of study (approximately 7 weeks) | AUC of HRS9531 after single subcutaneous injection |
| Immunogenicity qualitative | Start of Treatment to end of study (approximately 7 weeks) | anti-HRS9531 antibody |
| AUC of HRS9531 | Start of Treatment to end of study (approximately 9 weeks) | AUC of HRS9531 after multiple subcutaneous injections |
| Glucose concentration | Start of Treatment to end of study (approximately 9 weeks) | fasting plasma glucose |
Countries
China
Outcome results
None listed