A Safety, Tolerability, Pharmacokinetic Study of SHR-6934 Injection in Healthy Subjects (NCT06700083) | Clinical Trial Compass
CompletedPhase 1
A Safety, Tolerability, Pharmacokinetic Study of SHR-6934 Injection in Healthy Subjects
China72 participantsStarted 2025-01-06
Plain-language summary
This study was a randomized, double-blind, single-dose and multi-dose, placebo-controlled phase Ⅰ clinical trial. Six dose groups were planned for the SAD part of the study and four dose groups were planned for the MAD part. A total of 88 healthy subjects were included.
Who can participate
Age range
18 Years – 60 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
. Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF);
. Male or female aged 18-60;
. Females must have a negative pregnancy test at the Screening Visit;
. Body mass index (BMI) between 19 and 28 kg/m2;
. Normal Electrocardiogram (ECG);
. Men and women of childbearing potential must agree to take effective contraceptive methods.
Exclusion criteria
. History of any clinically important disease or disorder;
. History of drug or other allergies, or who, in the judgement of the investigator, may be allergic to the study drug or any component of the study drug;
. Prior history of risk factors for Torsades de Pointes, such as unexplained syncope, definite long QT syndrome (including family history), heart failure, myocardial infarction, angina pectoris;
. Systolic blood pressure (SBP)≥140 mmHg or \<90 mmHg, diastolic blood pressure (DBP) ≥90 mmHg or \<60 mmHg;
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
1
Incidence of subjects with adverse events (AEs)
Timeframe: Baseline up to 113 days after the last dosing