RecruitingPhase 1NCT07200596

The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of SHR-3045 in Healthy Subjects

The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Dose Subcutaneous Injection of SHR-3045 in Healthy Subjects-A Randomized, Double-Blind, Dose-Escalating, Placebo-Controlled Phase I Study

Sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Enrollment

16 participants

Start Date

Oct 8, 2025

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis (RA)

Summary

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single-dose subcutaneous injection of SHR-3045 in healthy subjects.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria5

Subjects with ability to understand the trial procedures and possible adverse events, voluntary participation in the trial.
Subjects who can provide written informed consent.
Males or females aged 18-55 years (both inclusive).
Males with body weight ≥ 50 kg, or females with body weight ≥ 45 kg, body mass index (BMI) 19-28 kg/m2 (both inclusive).
No clinically significant abnormalities in the medical history, general physical examinations, vital signs and laboratory tests.

Exclusion Criteria5

Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening.
Known or suspected history of drug abuse.
Addiction to tobacco and alcohol.
Individuals who are unable to adhere to the dietary requirements of this trial during the study period.
Judged by the investigator, there are any other conditions that interfere with the results evaluation of the trial.