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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05152277
• Other study ID #: HRS9531-101
• Status: Completed
• Phase: Phase 1
• Start date: December 6, 2021
• Est. completion date: August 24, 2022

Study information

• Verified date: September 2022
• Source: Fujian Shengdi Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 24, 2022
• Est. primary completion date: August 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• HRS9531
Administered SC once

Other:
• placebo
Administered SC once

Drug:
• HRS9531
Administered SC for multiple dose

Other:
• placebo
Administered SC for multiple dose

Locations

Country	Name	City	State
China	Jinan Central Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Shengdi Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Immunogenicity qualitative	anti-HRS9531 antibody	Start of Treatment to end of study (approximately 7 weeks)
Secondary	AUC of HRS9531	AUC of HRS9531 after multiple subcutaneous injections	Start of Treatment to end of study (approximately 9 weeks)
Secondary	Immunogenicity qualitative	anti-HRS9531 antibody	Start of Treatment to end of study (approximately 9 weeks)
Secondary	Glucose concentration	fasting plasma glucose	Start of Treatment to end of study (approximately 9 weeks)