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

NCT07479576 | Active Not Recruiting Phase 1

• 1 other identifier: QL2106-101
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics Endpoint

  Peak plasma concentration (Cmax)

  0-113 days

• Pharmacokinetics Endpoint

  Area under the plasma concentration versus time curve (AUC0-inf)

  0-113 days

Study Arms (2)

QL2106

EXPERIMENTAL

Drug: QL2106

Tremfye®

ACTIVE COMPARATOR

Drug: Tremfye®

Interventions

QL2106 DRUG

100mg/1 ml; single dose； subcutaneous injection

QL2106

Tremfye® DRUG

100mg/1 ml; single dose； subcutaneous injection

Tremfye®

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing GoBroad Hospital

Beijing, Beijing Municipality, 100000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: March 18, 2026
• Study Start: November 10, 2025
• Primary Completion: April 12, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: March 18, 2026

Record last verified: 2025-12

Locations

CN (1)