A PhaseⅠ Comparative Study to Evaluate the Pharmacokinetics of QL2108 to Dupixent®

A Randomized, Double-blinded, Parallel, Single-dose, PhaseⅠComparative Study to Evaluate the Pharmacokinetics and Safety of QL2108 to Dupixent® in Healthy Chinese Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06614907

Enrollment

198

Registered

2024-09-26

Start date

2024-08-31

Completion date

2024-12-27

Last updated

2025-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis

Brief 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®.

Detailed description

The study has a screening period of 28 days. PK blood samples will be collected from subjects to determine the serum concentration of Dupilumab, thus to evaluate the similarity of the pharmacokinetics of the two study drugs. The investigator will perform safety evaluation for vital signs, physical examinations, ECG, clinical laboratory tests and adverse events throughout the study. Immunogenicity evaluation (ADA, ADA titration and nAb) will also be evaluated.

Interventions

DRUGQL2108 injection

300mg/2.0mL; single dose; prefilled syringe; subcutaneous injection

DRUGDupixent®

300mg/2.0mL; single dose; prefilled syringe; subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 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.

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics Endpoint	0-8weeks	Cmax

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026