The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of SHR-3045 in Healthy Sub… (NCT07200596) | Clinical Trial Compass
CompletedPhase 1
The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of SHR-3045 in Healthy Subjects
China16 participantsStarted 2025-10-08
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 1 trial that already completed — what did the safety and tolerability results for SHR-3045 in healthy subjects actually show, and are there any red flags my doctor thinks I should know about before considering any future studies involving this drug?
2Since this trial only tested SHR-3045 in healthy volunteers and focused on adverse events, does that mean there's still very limited data on how it actually affects people with rheumatoid arthritis like me?
3Given that SHR-3045 is still in early-stage research, would my doctor recommend I first explore established RA treatments before looking at trials involving this drug?
4Are there any follow-up Phase 2 trials of SHR-3045 in actual RA patients that my doctor knows about, and would it be worth discussing whether I might be a candidate for those instead?
5Based on the pharmacokinetics and pharmacodynamics data collected in this completed trial, does my doctor have a sense of how SHR-3045 works in the body and whether that mechanism seems relevant to my specific type of RA?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.