A Comparative Phase 1 Study to Evaluate the Pharmacokinetic and Safety of QL2106 vs Tremfye® in H… (NCT07479576) | Clinical Trial Compass
CompletedPhase 1
A Comparative Phase 1 Study to Evaluate the Pharmacokinetic and Safety of QL2106 vs Tremfye® in Healthy Subjects
China190 participantsStarted 2025-11-10
Plain-language summary
This is a randomized, double-blinded, controlled Phase 1 study to compare the pharmacokinetic, safety and immunogenicity of QL2106 versus Tremfye®(Guselkumab) in healthy subjects after a single dose.
Who can participate
Age range
18 Years – 45 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:
* Healthy subjects aged from 18 to 45 years (including the boundary value);
* BMI between 19-26 kg/m2 (including boundary value) and body weight between 50-90 kg (including boundary value);
* Normal results of physical examination/laboratory examination/ECG or abnormal with no clinical significance according to the PI's judgment;
* The subject (including partner) has no pregnancy plan or sperm donation plan during the whole trial period and within 3 months after the completion of the drug administration and voluntarily adopts effective contraceptive measures;
* Sign the informed consent before joining the study, and fully understand the content, process and possible risks.
Exclusion Criteria:
* History of allergic reactions or hypersensitivity to Guselkumab, other IL-23 biologics or excipients;
* Alcoholics,or subjects who consumed more than 14 units of alcohol per week in the 6 months before screening;
* Those who had lost blood or donated at least 400 mL in the 3 months prior to screening, or had lost blood or donated at least 200 mL in the 1 month prior to screening, or planned to donate blood during the trial;
* Those who smoked more than 5 cigarettes per day in the 3 months before screening;
* Drug users in the 5 years prior to screening, or positive urine drug screening;
* Having used Guselkumab (or its biosimilars) or interleukin (IL-23) targeting agents;
* Those who have been enrolled in other clinical studies or less than 3 months since the end…
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.