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

NCT ID: NCT05152277

Last Updated: 2022-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-06
• Study Completion Date: 2022-08-24

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Single dose escalation of HRS9531 injection in healthy subjects

Group Type: EXPERIMENTAL

HRS9531

Intervention Type: DRUG

Administered SC once

Single dose of placebo in healthy adults

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Administered SC once

Multiple dose escalation of HRS9531 injection in healthy subjects

Group Type: EXPERIMENTAL

HRS9531

Intervention Type: DRUG

Administered SC for multiple dose

Multiple dose of placebo in healthy adults

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Administered SC for multiple dose

Interventions

HRS9531

Administered SC once

Intervention Type: DRUG

placebo

Administered SC once

Intervention Type: OTHER

HRS9531

Administered SC for multiple dose

Intervention Type: DRUG

placebo

Administered SC for multiple dose

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fujian Shengdi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jinan Central Hospital

Jinan, Shandong, China

Countries

China

Other Identifiers

HRS9531-101

Identifier Type: -

Identifier Source: org_study_id