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

Fujian Shengdi Pharmaceutical Co., Ltd.1 site in 1 country90 target enrollmentDecember 6, 2021

ConditionsType 2 Diabetes

InterventionsHRS9531 placebo

DrugsHRS9531

Overview

Phase: Phase 1
Intervention: HRS9531
Conditions: Type 2 Diabetes
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Enrollment: 90
Locations: 1
Primary Endpoint: Number of Adverse Events
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 6, 2021

End Date

August 24, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Single dose escalation of HRS9531 injection in healthy subjects

Intervention: HRS9531

Single dose of placebo in healthy adults

Intervention: placebo

Multiple dose escalation of HRS9531 injection in healthy subjects

Intervention: HRS9531

Multiple dose of placebo in healthy adults

Intervention: placebo

Outcomes

Primary Outcomes

Number of Adverse Events

Time Frame: Start of Treatment to end of study (approximately 7 weeks or 9 weeks)

A summary of adverse events, including Serious Adverse Events(SAEs)

Secondary Outcomes

Area under the plasma concentration-time curve (AUC) of HRS9531(Start of Treatment to end of study (approximately 7 weeks))
AUC of HRS9531(Start of Treatment to end of study (approximately 9 weeks))
Glucose concentration(Start of Treatment to end of study (approximately 9 weeks))
Immunogenicity qualitative(Start of Treatment to end of study (approximately 9 weeks))