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

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Other: placebo; Drug: HRS9531

• Registration Number: NCT05152277
• Lead Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2021-11-29
• Study Start: 2021-12-06
• Study First Posted: 2021-12-09
• Primary Completion: 2022-08-24
• Study Completion: 2022-08-24
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-16
• Last Update Posted: 2022-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single dose of placebo in healthy adults	placebo	-
Multiple dose of placebo in healthy adults	placebo	-
Single dose escalation of HRS9531 injection in healthy subjects	HRS9531	-
Multiple dose escalation of HRS9531 injection in healthy subjects	HRS9531	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Immunogenicity qualitative	Start of Treatment to end of study (approximately 9 weeks)	anti-HRS9531 antibody

Trial Locations

Locations (1)

Jinan Central Hospital; 🇨🇳 Jinan, Shandong, China