Healthy ParticipantsPhase 1NCT07327697
A Comparative Phase 1 Study to Evaluate the Pharmacokinetic and Safety of QL2302 vs. Tezspire® in Healthy Subjects
A Phase 1 study testing QL2302 and Tezspire in people with Healthy Participants, run by Qilu Pharmaceutical Co., Ltd..
Trial summary
This is a randomized, double-blinded, controlled Phase 1 study to compare the pharmacokinetic, safety and immunogenicity of QL2302 versus Tezspire®（Tezepelumab） 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?
- QL2302 and Tezspire
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- No sites listed yet
- Study dates
- 22 Dec 2025to Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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), male and female.
- Body weight 50.0-85.0 kg (including boundary value), and BMI 19.0-26.0 kg/m2 (including boundary value).
- Normal results or abnormal results with no clinical significance of disease history/vital signs/laboratory examination/ECG according to the PI's judgment.
- The subject (including partner) has no pregnancy plan or sperm donation plan during the whole trial period, and voluntarily adopts effective contraceptive measures.
- Sign the informed consent before participating the study, and fully understand the content, process and possible risks.
Who cannot join
- History of allergic reactions or hypersensitivity to Tezepelumab or excipients, or other biologics.
- Donated at least 400 mL within 3 months prior to screening, or at least 200 mL within 4 weeks prior to the screening visit, or plan to donate blood during the study.
- Smoked more than 5 cigarettes on average per day within 3 months prior to the screening visit.
- Diagnosed as alcoholic, or subjects who consumed more than 14 units of alcohol per week within 6 months before the screening visit, or with positive alcohol test result on Day-1.
- Drug abusers within 1 year prior to the screening visit, or subjects with positive urine drug test result during the screening period or on Day-1.
- History of hospitalization due to infection or receiving anti-infection therapy through intravenous within 8 weeks prior to the screening visit, or had infection within 2 weeks prior to the screening visit.
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- Diagnosed a helminth parasitic infection within 6 months prior to the screening visit that has not been treated or has not responded to standard of care therapy.
- History of active TB infection or a positive TB test result during screening period.
- History of malignancy (except for NMSC treated with apparent success ≥5 years prior to screening).
- Diagnosed with disease with abnormal clinical manifestations that should be excluded as judged by the PI.
- History of treated by Tezepelumab or other TSLP-targeted biologics.
- Have used prescription, OTC, herbal medicine, or health supplement within 2 weeks prior to randomization.
- Vaccination with a live vaccine within 4 weeks or a attenuated vaccine within 2 weeks prior to randomization.
- Have used biologics within 3 months prior to randomization, or within 5 half-life period before randomization. (whichever is longer)
- Receiving treatment with any investigational product within 3 month prior to randomization or in 5 half-life period (whichever is longer), or treatment with any investigational equipment within 3 month prior to randomization.
- Positive HbsAg, or HCV-Ab, or TPAb, or HIV antibody tests.
- Female is pregnant or breastfeeding, or female who have not taken effective contraceptive measures within 14 days prior to randomization, or female with positive blood pregnant test.
- Other conditions that considered inappropriate for participating the study, as per the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-blinded, Parallel, Positive-controlled Study to Compare the Pharmacokinetic, Safety and Immunogenicity of Single-dose QL2302 vs. Tezspire ® in Healthy Subjects
This is a randomized, double-blinded, controlled Phase 1 study to compare the pharmacokinetic, safety and immunogenicity of QL2302 versus Tezspire®（Tezepelumab） in healthy subjects after a single dose.
- Conditions
- Healthy Participants
- Being tested
- QL2302, Tezspire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL2302Drug
210mg/1.91mL; single dose; subcutaneous injection
TezspireDrug
210mg/1.91mL; single dose; subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| QL2302 | Experimental | Not described Receives: Drug: QL2302 |
| Tezspire® | Active comparator | Not described Receives: Drug: Tezspire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics Endpoint
Peak plasma concentration (Cmax)
Measured: Day 1-Day 134
Pharmacokinetics Endpoint
Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-∞)
Measured: Day 1-Day 134
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start22 Dec 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionSep 2026 (estimated)
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
- 178 participants (estimated)
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
- NCT07327697
- Sponsor's protocol ID
- QL2302-101
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 8 Jan 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 8 Jan 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 QL2302 vs. Tezspire ® in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07327697
- Acronym / sponsor ID
- QL2302-101
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 8 Jan 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 QL2302 versus Tezspire®（Tezepelumab） 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 |
|---|---|---|
| QL2302 | Experimental | Drug: QL2302 |
| Tezspire® | Active comparator | Drug: Tezspire |
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), male and female.
- Body weight 50.0-85.0 kg (including boundary value), and BMI 19.0-26.0 kg/m2 (including boundary value).
- Normal results or abnormal results with no clinical significance of disease history/vital signs/laboratory examination/ECG according to the PI's judgment.
- The subject (including partner) has no pregnancy plan or sperm donation plan during the whole trial period, and voluntarily adopts effective contraceptive measures.
- Sign the informed consent before participating the study, and fully understand the content, process and possible risks.
Key exclusion criteria (18 listed)
- History of allergic reactions or hypersensitivity to Tezepelumab or excipients, or other biologics.
- Donated at least 400 mL within 3 months prior to screening, or at least 200 mL within 4 weeks prior to the screening visit, or plan to donate blood during the study.
- Smoked more than 5 cigarettes on average per day within 3 months prior to the screening visit.
- Diagnosed as alcoholic, or subjects who consumed more than 14 units of alcohol per week within 6 months before the screening visit, or with positive alcohol test result on Day-1.
- Drug abusers within 1 year prior to the screening visit, or subjects with positive urine drug test result during the screening period or on Day-1.
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 |
|---|---|---|
| QL2302210mg/1.91mL; single dose; subcutaneous injection | Drug | QL2302 |
| Tezspire210mg/1.91mL; single dose; subcutaneous injection | Drug | Tezspire® |
Primary outcome
Pharmacokinetics Endpoint
Time frame: Day 1-Day 134
Peak plasma concentration (Cmax)
Pharmacokinetics Endpoint
Time frame: Day 1-Day 134
Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-∞)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QL2302 and Tezspire in people with Healthy Participants, run by Qilu Pharmaceutical Co., Ltd..
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 18 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: opening soon, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YU CAO, PPD (18661809090, caoyu1767@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics Endpoint (time frame: Day 1-Day 134). 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 8 Jan 2026.