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

March 11, 2025 updated by: Qilu Pharmaceutical Co., Ltd.

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

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®.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250013
        • Jinan Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QL2108 injection
QL2108 injection; 300mg/2.0mL; subcutaneous injection
Drug: QL2108 injection
300mg/2.0mL; single dose; prefilled syringe; subcutaneous injection
Active Comparator: Dupixent®
Dupixent®; 300mg/2.0mL; subcutaneous injection
Drug: Dupixent®
300mg/2.0mL; single dose; prefilled syringe; subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics Endpoint
Time Frame: 0-8weeks
Cmax
0-8weeks
Pharmacokinetics Endpoint
Time Frame: 0-8weeks
AUC0-∞
0-8weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Qing Wen, Jinan Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2024

Primary Completion (Actual)

November 15, 2024

Study Completion (Actual)

December 27, 2024

Study Registration Dates

First Submitted

September 24, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QL2108-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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