CompletedPhase 1

A Phase Ⅰ Clinical Trial to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of SHR-3045 in Healthy Subjects

China40 participantsStarted 2025-04-08

Plain-language summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics 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.
. 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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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.

What they're measuring

Adverse events (AEs)

Timeframe: From screening period up to day 113.

Trial details

NCT IDNCT06883695

SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-17

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