NCT06614907CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 12 Mar 2025
Brief summary (registry, in English)
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®.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 198 (actual)
- First submitted
- 24 Sept 2024
- Start date
- 31 Aug 2024
- Primary completion date
- 15 Nov 2024
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06614907
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 198
- From 31 Aug 2024 to the primary completion date, 15 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other
- People who have special dietary requirements or are unable to follow a uniform diet.
Who the study is looking for
- 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);
Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.