Safety, Tolerability and Pharmacokinetic Studies of HRS-2183 for Injection in Healthy Chinese Subjects After Single and Multiple Administration

This study mainly evaluated the safety and tolerability, as well as the pharmacokinetic characteristics, of the injectable drug HRS-2183 after single and multiple administrations in healthy subjects.

Study Overview

• Status: Recruiting
• Conditions: Chinese Healthy Adult Subjects
• Intervention / Treatment: Drug: Placebo; Drug: HRS-2183

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yuanyuan Huang; Phone Number: +0518-82342973; Email: yuanyuan.huang@hengrui.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250100
      • Recruiting
      • Qilu Hospital of Shandong University
      • Principal Investigator: Wei Zhao
      • Principal Investigator: Yuguo Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy male and female subjects, aged 18 to 45 years.
2. Body weight and Body Mass Index (BMI) within a specified range (e.g., BMI 19.0-26.0 kg/m²).
3. Agreement to use highly effective contraception during the study period and for a specified duration after the last dose. No plans for pregnancy, sperm/egg donation.
4. Voluntarily provides written informed consent to participate in the study.

Exclusion Criteria:

1. History of significant allergies to any food or drug, especially to the investigational product, its components, or drugs of a similar class.
2. History or current presence of any clinically significant disease in major organ systems (e.g., cardiovascular, hepatic, renal, neurological, etc.).
3. Any clinically significant abnormalities found during screening assessments (including physical examination, vital signs, and laboratory tests).
4. Clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening.
5. Evidence of impaired renal function based on laboratory tests (e.g., eGFR, serum creatinine).
6. Positive screening for specified infectious diseases (e.g., HIV, HBV, HCV, Syphilis).
7. Use of any medication (including prescription, OTC, and herbal) within a specified period before the study.
8. Excessive consumption of certain beverages (e.g., caffeine, grapefruit juice) or inability to adhere to dietary restrictions.
9. History of major surgery within the past 3 months or planned surgery during the study period.
10. Participation in another clinical trial within the past 3 months.
11. Significant blood loss, blood donation, or transfusion within the past 3 months.
12. History of excessive alcohol consumption or unwillingness to abstain during the study.
13. History of heavy smoking or unwillingness to abstain during the study.
14. History of drug abuse or positive drug screening test.
15. Inability to tolerate venous access or history of fainting during blood draws.
16. Inability to comply with the standardized diet provided during the study.
17. Any other reason that, in the opinion of the investigator, makes the subject unsuitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A:HRS-2183	Drug: HRS-2183; HRS-2183
Placebo Comparator: Treatment group B:placebo	Drug: Placebo; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of any adverse events	Evaluation was performed up to the seventh day / the 16th day

Secondary Outcome Measures

Outcome Measure	Time Frame
Tmax (Pharmacokinetic Parameters after a Single Dose)	Evaluation was performed up to the third day
Cmax(Pharmacokinetic Parameters after a Single Dose)	Evaluation was performed up to the third day
AUC0-t(Pharmacokinetic Parameters after a Single Dose)	Evaluation was performed up to the third day
AUC0-∞(Pharmacokinetic Parameters after a Single Dose)	Evaluation was performed up to the third day
t1/2(Pharmacokinetic Parameters after a Single Dose)	Evaluation was performed up to the third day
CLz(Pharmacokinetic Parameters after a Single Dose)	Evaluation was performed up to the third day
Vz(Pharmacokinetic Parameters after a Single Dose)	Evaluation was performed up to the third day
Ae0-t(Pharmacokinetic Parameters after a Single Dose)	Evaluation was performed up to the third day
Fe0-t(Pharmacokinetic Parameters after a Single Dose)	Evaluation was performed up to the third day
CLr(Pharmacokinetic Parameters after a Single Dose)	Evaluation was performed up to the third day
Tmax(Pharmacokinetic Parameters after Multiple Doses)	Evaluation was performed up to the 12th day
Cmin,ss(Pharmacokinetic Parameters after Multiple Doses)	Evaluation was performed up to the 12th day
Cmax,ss(Pharmacokinetic Parameters after Multiple Doses)	Evaluation was performed up to the 12th day
Cav(Pharmacokinetic Parameters after Multiple Doses)	Evaluation was performed up to the 12th day
AUC0-t,ss(Pharmacokinetic Parameters after Multiple Doses)	Evaluation was performed up to the 12th day
AUC0-τ,ss(Pharmacokinetic Parameters after Multiple Doses)	Evaluation was performed up to the 12th day
AUC0-∞,ss(Pharmacokinetic Parameters after Multiple Doses)	Evaluation was performed up to the 12th day
t1/2(Pharmacokinetic Parameters after Multiple Doses)	Evaluation was performed up to the 12th day
CLss(Pharmacokinetic Parameters after Multiple Doses)	Evaluation was performed up to the 12th day
Vss(Pharmacokinetic Parameters after Multiple Doses)	Evaluation was performed up to the 12th day
Rac(Pharmacokinetic Parameters after Multiple Doses)	Evaluation was performed up to the 12th day
DF(Pharmacokinetic Parameters after Multiple Doses)	Evaluation was performed up to the 12th day

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HRS-2183-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No