A PhaseⅠ Comparative Study to Evaluate the Pharmacokinetics of QL2108 to Dupixent®
NCT ID: NCT06614907
Last Updated: 2025-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
198 participants
INTERVENTIONAL
2024-08-31
2024-12-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase Ⅲ Comparative Study of QL2108 to Dupixent®
NCT06884891
A Phase 2 Study of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis
NCT06058000
A Phase 2 Study to Evaluate the Efficacy, Safety of SIM0278 in Subjects With Moderate to Severe Atopic Dermatitis
NCT07175233
A Phase I Study of QLS12010 Capsules: Safety, Tolerability, PK, PD, and Food Effects in Healthy Adults and Moderate to Severe Atopic Dermatitis Patients
NCT06946641
A Study of QY201 Tablet in Subjects With Moderate to Severe Atopic Dermatitis
NCT05525715
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
QL2108 injection
QL2108 injection; 300mg/2.0mL; subcutaneous injection
QL2108 injection
300mg/2.0mL; single dose; prefilled syringe; subcutaneous injection
Dupixent®
Dupixent®; 300mg/2.0mL; subcutaneous injection
Dupixent®
300mg/2.0mL; single dose; prefilled syringe; subcutaneous injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
QL2108 injection
300mg/2.0mL; single dose; prefilled syringe; subcutaneous injection
Dupixent®
300mg/2.0mL; single dose; prefilled syringe; subcutaneous injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Qing Wen
Role: PRINCIPAL_INVESTIGATOR
Jinan Central Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jinan Central Hospital
Jinan, Shandong, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
QL2108-101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.