Healthy ParticipantsPhase 1NCT07479576
A Comparative Phase 1 Study to Evaluate the Pharmacokinetic and Safety of QL2106 vs Tremfye® in Healthy Subjects
A Phase 1 study testing QL2106 and Tremfye® in people with Healthy Participants, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, double-blinded, controlled Phase 1 study to compare the pharmacokinetic, safety and immunogenicity of QL2106 versus Tremfye®（Guselkumab） in healthy subjects after a single dose. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- QL2106 and Tremfye®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2025to 23 Apr 2026
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects aged from 18 to 45 years (including the boundary value)；
- BMI between 19-26 kg/m2 (including boundary value) and body weight between 50-90 kg (including boundary value);
- Normal results of physical examination/laboratory examination/ECG or abnormal with no clinical significance according to the PI's judgment;
- The subject (including partner) has no pregnancy plan or sperm donation plan during the whole trial period and within 3 months after the completion of the drug administration and voluntarily adopts effective contraceptive measures;
- Sign the informed consent before joining the study, and fully understand the content, process and possible risks.
Who cannot join
- History of allergic reactions or hypersensitivity to Guselkumab, other IL-23 biologics or excipients;
- Alcoholics，or subjects who consumed more than 14 units of alcohol per week in the 6 months before screening;
- Those who had lost blood or donated at least 400 mL in the 3 months prior to screening, or had lost blood or donated at least 200 mL in the 1 month prior to screening, or planned to donate blood during the trial；
- Those who smoked more than 5 cigarettes per day in the 3 months before screening;
- Drug users in the 5 years prior to screening, or positive urine drug screening；
- Having used Guselkumab (or its biosimilars) or interleukin (IL-23) targeting agents;
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- Those who have been enrolled in other clinical studies or less than 3 months since the end of the most recent clinical study;
- Use of any prescription drug, over-the-counter drug or health product within 14 days prior to screening
- Any one of HBV surface antigen, HCV antibody, HIV antibody, treponema pallidum antibody positive;
- Other conditions considered inappropriate to be included in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blinded, Parallel, Positive-controlled Study to Compare the Pharmacokinetic, Safety and Immunogenicity of Single-dose QL2106 vs Tremfye® in Healthy Subjects
This is a randomized, double-blinded, controlled Phase 1 study to compare the pharmacokinetic, safety and immunogenicity of QL2106 versus Tremfye®（Guselkumab） in healthy subjects after a single dose.
- Conditions
- Healthy Participants
- Being tested
- QL2106, Tremfye®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL2106Drug
100mg/1 ml; single dose； subcutaneous injection
Tremfye®Drug
100mg/1 ml; single dose； subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| QL2106 | Experimental | Not described Receives: Drug: QL2106 |
| Tremfye® | Active comparator | Not described Receives: Drug: Tremfye® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics Endpoint
Peak plasma concentration (Cmax)
Measured: 0-113 days
Pharmacokinetics Endpoint
Area under the plasma concentration versus time curve (AUC0-inf)
Measured: 0-113 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start10 Nov 2025
- Primary completion23 Apr 2026
- Study completion23 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479576
- Sponsor's protocol ID
- QL2106-101
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 5 Aug 2026
- 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 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Parallel, Positive-controlled Study to Compare the Pharmacokinetic, Safety and Immunogenicity of Single-dose QL2106 vs Tremfye® in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07479576
- Acronym / sponsor ID
- QL2106-101
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 23 Apr 2026 (actual)
- Study completion
- 23 Apr 2026 (actual)
- First posted
- 18 Mar 2026 (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.
This is a randomized, double-blinded, controlled Phase 1 study to compare the pharmacokinetic, safety and immunogenicity of QL2106 versus Tremfye®（Guselkumab） in healthy subjects after a single dose.
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 |
|---|---|---|
| QL2106 | Experimental | Drug: QL2106 |
| Tremfye® | Active comparator | Drug: Tremfye® |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy subjects aged from 18 to 45 years (including the boundary value)；
- BMI between 19-26 kg/m2 (including boundary value) and body weight between 50-90 kg (including boundary value);
- Normal results of physical examination/laboratory examination/ECG or abnormal with no clinical significance according to the PI's judgment;
- The subject (including partner) has no pregnancy plan or sperm donation plan during the whole trial period and within 3 months after the completion of the drug administration and voluntarily adopts effective contraceptive measures;
- Sign the informed consent before joining the study, and fully understand the content, process and possible risks.
Key exclusion criteria (10 listed)
- History of allergic reactions or hypersensitivity to Guselkumab, other IL-23 biologics or excipients;
- Alcoholics，or subjects who consumed more than 14 units of alcohol per week in the 6 months before screening;
- Those who had lost blood or donated at least 400 mL in the 3 months prior to screening, or had lost blood or donated at least 200 mL in the 1 month prior to screening, or planned to donate blood during the trial；
- Those who smoked more than 5 cigarettes per day in the 3 months before screening;
- Drug users in the 5 years prior to screening, or positive urine drug screening；
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 |
|---|---|---|
| QL2106100mg/1 ml; single dose； subcutaneous injection | Drug | QL2106 |
| Tremfye®100mg/1 ml; single dose； subcutaneous injection | Drug | Tremfye® |
Primary outcome
Pharmacokinetics Endpoint
Time frame: 0-113 days
Peak plasma concentration (Cmax)
Pharmacokinetics Endpoint
Time frame: 0-113 days
Area under the plasma concentration versus time curve (AUC0-inf)
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 5 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 QL2106 and Tremfye® in people with Healthy Participants, 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 5 inclusion and 10 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 5 Aug 2026. 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: 0-113 days). 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 5 Aug 2026.