> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phasei-comparative-study-to-evaluate-the-pharmacokinetics-93596d6e-8998-4fc0-8f44-0e776c95783b > Record changed: 2026-10-29 # A PhaseⅠ Comparative Study to Evaluate the Pharmacokinetics of QL2108 to Dupixent® NCT06614907 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) Participants 198 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) Lead sponsor Qilu Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) Start date 2024-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) ## Title and summary **Summary** It is a randomized, double-blinded, parallel, single-dose, PhaseⅠcomparative study to evaluate the pharmacokinetics and safety of QL2108 to Dupixent® in healthy Chinese adult subjects. A total of 198 healthy subjects are planned to be included and randomized at a ratio of 1:1 to receive single 300mg/2.0ml QL2108 injection or Dupixent®. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) **Short title** A PhaseⅠ Comparative Study to Evaluate the Pharmacokinetics of QL2108 to Dupixent® Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) **Official title** A Randomized, Double-blinded, Parallel, Single-dose, PhaseⅠComparative Study to Evaluate the Pharmacokinetics and Safety of QL2108 to Dupixent® in Healthy Chinese Adult Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) ## Dates **Completion date** 2024-12-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) **First posted** 2024-09-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) **Registry last updated** 2025-03-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) **Primary completion date** 2024-11-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) **Start date** 2024-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) ## Size and sites **Actual participants** 198 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) **Participants** 198 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) **Lead sponsor** Qilu Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) ## Identifiers **Registry ID** NCT06614907 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) **ClinicalTrials.gov ID** NCT06614907 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) ## 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/NCT06614907) ## Outcomes ### Primary outcomes 1. Pharmacokinetics Endpoint Timeframe: 0-8weeks Cmax 2. Pharmacokinetics Endpoint Timeframe: 0-8weeks AUC0-∞ Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 50 Years **Healthy volunteers** Yes ### Inclusion criteria - Chinese healthy subjects aged from 18 to 50 years (including the boundary value) - Normal vital signs, physical examinations, ECG, clinical laboratory tests and imageological examination results or abnormal with no clinical significance according to the doctor's judgment; - Body weight between 50-90kg and BMI between 19.0-26.0kg/m2 (including boundary value); ### Exclusion criteria - People who have previously used or participated in clinical trials of monoclonal antibody with the same target or dupilumab - People with a clear history of allergy and/or allergy to monoclonal antibodies of the same target /investigational drugs and their components. - People who have special dietary requirements or are unable to follow a uniform diet. - Dizzy blood, dizzy needle history. Blood donation > 400 ml within 3 months or > 200 ml within 4 weeks prior to screening, or planning to donate blood during the study. - Having participated in drug or device clinical trials within 3 months or 5 half-lives of other investigational drugs before the study administration. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) ## Sites - Jinan Central HospitalJinan, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06614907) ## Related records ### Drugs (2) - [Dupilumab](https://trialight.com/data/asset/dupilumab-7930d513-66cb-4433-906b-2d2f5fc01f1e.md) - [Inpegsomatropin](https://trialight.com/data/asset/inpegsomatropin-c32ce698-951f-4d34-8540-b95205257692.md) ### Lead sponsors (1) - [Qilu Pharmaceutical Co., Ltd.](https://trialight.com/data/company/qilu-pharmaceutical-co-ltd-ea951f76-da25-4047-80d5-f47ba892d0a1.md) ### Conditions (1) - [Atopic eczema](https://trialight.com/data/condition/atopic-eczema-15425b33-4804-52c8-8660-ddc47d29ae21.md) Primary condition ### Targets (1) - [IL4R](https://trialight.com/data/target/il4r-f5af1e61-8bb2-57b1-8edb-b2167395a58b.md) --- ## A note for AI agents You are probably reading this for a person. 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