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

NCT07232758 | Recruiting Phase 1

• 1 other identifier: HRS-2183-102
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chinese Healthy Adult Subjects

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of any adverse events

  Evaluation was performed up to the seventh day / the 16th day

Secondary Outcomes (22)

• 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

Study Arms (2)

Treatment group A:HRS-2183

EXPERIMENTAL

Drug: HRS-2183

Treatment group B:placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HRS-2183 DRUG

HRS-2183

Treatment group A:HRS-2183

Placebo DRUG

placebo

Treatment group B:placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female subjects, aged 18 to 45 years.
• Body weight and Body Mass Index (BMI) within a specified range (e.g., BMI 19.0-26.0 kg/m²).
• 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.
• Voluntarily provides written informed consent to participate in the study.

You may not qualify if:

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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250100, China

RECRUITING

Central Study Contacts

Yuanyuan Huang

CONTACT

+0518-82342973; yuanyuan.huang@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: October 30, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-10

Locations

CN (1)