Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS9531 in Healthy Subjects

Study Overview
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Brief Summary
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The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple subcutaneous injections of HRS9531 in healthy subjects.

Official Title
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A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administered HRS9531

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: HRS9531
* Other: placebo
* Drug: HRS9531
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent; Age 18-55 years on the date of signing informed consent (inclusive); Body weight ≥50 kg, body mass index (BMI) within the range of 19.0-35.0 kg/m2 (inclusive); Subjects with good general health, no clinically significant abnormalities. Exclusion Criteria: 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; Had a severe trauma or major surgery within 6 months prior to screening, planned to undergo surgery during the trial period; Participants in clinical trials of any drug or medical device in the 3 months prior to screening; Blood donation history or blood loss ≥400 mL within 1 month before screening, or received blood transfusion within 2 months; Allergic constitution includes severe drug allergy or history of drug allergy; Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive; Breast-feeding women; The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: HRS9531 compared with placebo
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single dose escalation of HRS9531 injection in healthy subjects<br> | Drug: HRS9531<br>* Administered SC once<br>|
| Placebo Comparator: Single dose of placebo in healthy adults<br> | Other: placebo<br>* Administered SC once<br>|
| Experimental: Multiple dose escalation of HRS9531 injection in healthy subjects<br> | Drug: HRS9531<br>* Administered SC for multiple dose<br>|
| Placebo Comparator: Multiple dose of placebo in healthy adults<br> | Other: placebo<br>* Administered SC for multiple dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |