A Comparative Phase 1 Study to Evaluate the Pharmacokinetic and Safety of QL2302 vs. Tezspire® in Healthy Subjects
NCT07327697
Phase
Phase 1
Recruitment status
Not yet recruiting
Participants
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Start date
2025-12-22
- 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.
- Short title
- A Comparative Phase 1 Study to Evaluate the Pharmacokinetic and Safety of QL2302 vs. Tezspire® in Healthy Subjects
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-09-01
- First posted
- 2026-01-08
- Registry last updated
- 2026-01-08
- Primary completion date
- 2026-07-01
- Start date
- 2025-12-22
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Registry sponsor category
- Industry
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07327697
- ClinicalTrials.gov ID
- NCT07327697
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Sources for study design
Pharmacokinetics Endpoint
Timeframe: Day 1-Day 134
Peak plasma concentration (Cmax)
Pharmacokinetics Endpoint
Timeframe: Day 1-Day 134
Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-∞)
Sources for outcomes
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 45 Years
- Healthy volunteers
- Yes
- 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.
- 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.
- 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.
Sources for eligibility