Atopic DermatitisPhase 1NCT06614907
A PhaseⅠ Comparative Study to Evaluate the Pharmacokinetics of QL2108 to Dupixent®
A Phase 1 study testing QL2108 injection and Dupixent® in people with Atopic Dermatitis, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- QL2108 injection and Dupixent®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2024to 27 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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);
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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®.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- QL2108 injection, Dupixent®
- Keywords
- Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL2108 injectionDrug
300mg/2.0mL; single dose; prefilled syringe; subcutaneous injection
Dupixent®Drug
300mg/2.0mL; single dose; prefilled syringe; subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| QL2108 injection | Experimental | QL2108 injection; 300mg/2.0mL; subcutaneous injection Receives: Drug: QL2108 injection |
| Dupixent® | Active comparator | Dupixent®; 300mg/2.0mL; subcutaneous injection Receives: Drug: Dupixent® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics Endpoint
Cmax
Measured: 0-8weeks
Pharmacokinetics Endpoint
AUC0-∞
Measured: 0-8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start31 Aug 2024
- Primary completion15 Nov 2024
- Study completion27 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qing Wen, Principal investigator, Jinan Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614907
- Sponsor's protocol ID
- QL2108-101
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06614907
- Acronym / sponsor ID
- QL2108-101
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL2108 injection | Experimental | Drug: QL2108 injectionQL2108 injection; 300mg/2.0mL; subcutaneous injection |
| Dupixent® | Active comparator | Drug: Dupixent®Dupixent®; 300mg/2.0mL; subcutaneous injection |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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);
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QL2108 injection300mg/2.0mL; single dose; prefilled syringe; subcutaneous injection | Drug | QL2108 injection |
| Dupixent®300mg/2.0mL; single dose; prefilled syringe; subcutaneous injection | Drug | Dupixent® |
Primary outcome
Pharmacokinetics Endpoint
Time frame: 0-8weeks
Cmax
Pharmacokinetics Endpoint
Time frame: 0-8weeks
AUC0-∞
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qing Wen principal investigator
Jinan Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QL2108 injection and Dupixent® in people with Atopic Dermatitis, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics Endpoint (time frame: 0-8weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.