A Comparative Phase 1 Study to Evaluate the Pharmacokinetic and Safety of QL2106 vs Tremfye® in Healthy Subjects

A Randomized, Double-blinded, Parallel, Positive-controlled Study to Compare the Pharmacokinetic, Safety and Immunogenicity of Single-dose QL2106 vs Tremfye® in Healthy Subjects

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.

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.