Status:
RECRUITING
The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of SHR-3045 in Healthy Subjects
Lead Sponsor:
Guangdong Hengrui Pharmaceutical Co., Ltd
Conditions:
Rheumatoid Arthritis (RA)
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT07200596
Start Date
October 8 2025
End Date
March 1 2026
Last Update
November 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Frist Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, Anhui, China, 230001