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

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05152277
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 10.8
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: HRS9531; Other: placebo; Drug: HRS9531; Other: placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: HRS9531 compared with placeboHRS9531 compared with placebo
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: Dec 6, 2021
• Anticipated Primary Completion Date: Oct 31, 2022
• Anticipated Study Completion Date: Oct 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single dose escalation of HRS9531 injection in healthy subjects	Drug: HRS9531; Administered SC once
Placebo Comparator: Single dose of placebo in healthy adults	Other: placebo; Administered SC once
Experimental: Multiple dose escalation of HRS9531 injection in healthy subjects	Drug: HRS9531; Administered SC for multiple dose
Placebo Comparator: Multiple dose of placebo in healthy adults	Other: placebo; Administered SC for multiple dose

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Immunogenicity qualitative [Start of Treatment to end of study (approximately 7 weeks)]

   anti-HRS9531 antibody

3. AUC of HRS9531 [Start of Treatment to end of study (approximately 9 weeks)]

   AUC of HRS9531 after multiple subcutaneous injections

4. Immunogenicity qualitative [Start of Treatment to end of study (approximately 9 weeks)]

   anti-HRS9531 antibody

5. Glucose concentration [Start of Treatment to end of study (approximately 9 weeks)]

   fasting plasma glucose

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jinan Central Hospital	Jinan	Shandong	China	250013

Sponsors and Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fujian Shengdi Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05152277
• Other Study ID Numbers: HRS9531-101
• First Posted: Dec 9, 2021
• Last Update Posted: Jul 25, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 25, 2022