NCT07327697尚未招募1 期
A Randomized, Double-blinded, Parallel, Positive-controlled Study to Compare the Pharmacokinetic, Safety and Immunogenicity of Single-dose QL2302 vs. Tezspire ® in Healthy Subjects
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 178
- 主要终点
- Pharmacokinetics Endpoint
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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-
- •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-
- •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.
研究组 & 干预措施
Tezspire®
Active Comparator
干预措施: Tezspire (Drug)
QL2302
Experimental
干预措施: QL2302 (Drug)
结局指标
主要结局
Pharmacokinetics Endpoint
时间窗: Day 1-Day 134
Peak plasma concentration (Cmax)
次要结局
未报告次要终点
研究者
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