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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: QL2106; Drug: Tremfye®

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100000
      • Beijing GoBroad Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QL2106	Drug: QL2106; 100mg/1 ml; single dose； subcutaneous injection
Active Comparator: Tremfye®	Drug: Tremfye®; 100mg/1 ml; single dose； subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics Endpoint	Peak plasma concentration (Cmax)	0-113 days
Pharmacokinetics Endpoint	Area under the plasma concentration versus time curve (AUC0-inf)	0-113 days

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2025
• Primary Completion (Estimated): April 12, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: March 15, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 15, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: QL2106-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No