Status:
ACTIVE_NOT_RECRUITING
A Phase Ⅰ Clinical Trial to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of SHR-3045 in Healthy Subjects
Lead Sponsor:
Guangdong Hengrui Pharmaceutical Co., Ltd
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics 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.
- 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 :
April 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06883695
Start Date
April 8 2025
End Date
October 1 2025
Last Update
August 12 2025
Active Locations (1)
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1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080