A Phase Ⅰ Clinical Trial to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of SHR-3045 in Healthy Subjects
A Phase Ⅰ, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-3045 in Healthy Subjects
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-3045 in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 rheumatoid-arthritis
Started Apr 2025
Shorter than P25 for phase_1 rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2025
CompletedFirst Posted
Study publicly available on registry
March 19, 2025
CompletedStudy Start
First participant enrolled
April 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 17, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedAugust 12, 2025
August 1, 2025
2 months
March 13, 2025
August 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events (AEs)
From screening period up to day 113.
Secondary Outcomes (6)
Area under the concentration-time curve from time 0 to the last time point after SHR-3045 administration (AUC0-last).
Post-dose at day 1 to day 113.
Area under the concentration-time curve from time 0 to infinity after SHR-3045 administration (AUC0-inf).
Post-dose at day 1 to day 113.
Maximum observed concentration of SHR-3045 (Cmax).
Post-dose at day 1 to day 113.
Time to maximum observed concentration of SHR-3045 (Tmax).
Post-dose at day 1 to day 113.
Clearance of SHR-3045 (CL).
Post-dose at day 1 to day 113.
- +1 more secondary outcomes
Study Arms (2)
SHR-3045 Group
EXPERIMENTALSHR-3045 Placebo Group
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
March 13, 2025
First Posted
March 19, 2025
Study Start
April 8, 2025
Primary Completion
June 17, 2025
Study Completion
October 1, 2025
Last Updated
August 12, 2025
Record last verified: 2025-08