Healthy volunteers help test copycat drug against approved biologic
NCT ID NCT07479576
First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times
Summary
This study tests a new drug called QL2106 against an approved drug, Tremfye® (guselkumab), in 190 healthy adults aged 18-45. The goal is to compare how the body processes each drug, their safety, and immune response after a single dose. Participants receive one injection and are monitored for several months. This is a Phase 1 trial, so it focuses on safety and drug behavior, not on treating any disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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190 people
The number who actually took part.
- Started
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Nov 2025
- Finished
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Apr 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 of the most recent clinical study; * Use of any prescription drug, over-the-counter drug or health product within 14 days prior to screening * Any one of HBV surface antigen, HCV antibody, HIV antibody, treponema pallidum antibody positive; * Other conditions considered inappropriate to be included in this study.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beijing GoBroad Hospital
Beijing, Beijing Municipality, 100000, China
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