> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-comparative-phase-1-study-to-evaluate-the-pharmacokinetic-46f38f36-1d38-4361-a903-f7012e98f226 > Record changed: 2026-11-04 # A Comparative Phase 1 Study to Evaluate the Pharmacokinetic and Safety of QL2106 vs Tremfye® in Healthy Subjects NCT07479576 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) Participants 190 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) Lead sponsor Qilu Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) Start date 2025-11-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) **Short title** A Comparative Phase 1 Study to Evaluate the Pharmacokinetic and Safety of QL2106 vs Tremfye® in Healthy Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) **Official title** A Randomized, Double-blinded, Parallel, Positive-controlled Study to Compare the Pharmacokinetic, Safety and Immunogenicity of Single-dose QL2106 vs Tremfye® in Healthy Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) ## Dates **Completion date** 2026-04-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) **First posted** 2026-03-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) **Registry last updated** 2026-08-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) **Primary completion date** 2026-04-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) **Start date** 2025-11-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) ## Size and sites **Actual participants** 190 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) **Participants** 190 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) **Lead sponsor** Qilu Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) ## Identifiers **Registry ID** NCT07479576 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) **ClinicalTrials.gov ID** NCT07479576 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) ## Outcomes ### Primary outcomes 1. Pharmacokinetics Endpoint Timeframe: 0-113 days Peak plasma concentration (Cmax) 2. Pharmacokinetics Endpoint Timeframe: 0-113 days Area under the plasma concentration versus time curve (AUC0-inf) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 45 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) ## Sites - Beijing GoBroad HospitalBeijing, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07479576) ## Related records ### Drugs (1) - [Guselkumab](https://trialight.com/data/asset/guselkumab-90846a1b-25ed-4e53-ae9c-4730391bc3c9.md) ### Lead sponsors (1) - [Qilu Pharmaceutical Co., Ltd.](https://trialight.com/data/company/qilu-pharmaceutical-co-ltd-ea951f76-da25-4047-80d5-f47ba892d0a1.md) ### Targets (2) - [IL12B](https://trialight.com/data/target/il12b-92e53178-7b56-555c-ac6b-a1235d8fe7e5.md) - [IL23A](https://trialight.com/data/target/il23a-e11f3992-27b4-5bef-9242-07ab6ac420e9.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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