A Comparative Phase 1 Study to Evaluate the Pharmacokinetic and Safety of QL2302 vs. Tezspire® in Healthy Subjects

Официальное название

A Randomized, Double-blinded, Parallel, Positive-controlled Study to Compare the Pharmacokinetic, Safety and Immunogenicity of Single-dose QL2302 vs. Tezspire ® in Healthy Subjects

Обзор

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.

Вмешательства

• Препарат QL2302
  210mg/1.91mL; single dose; subcutaneous injection
• Препарат Tezspire
  210mg/1.91mL; single dose; subcutaneous injection

Первичные конечные точки

• Pharmacokinetics Endpoint [Срок оценки: Day 1-Day 134]
• Pharmacokinetics Endpoint [Срок оценки: Day 1-Day 134]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07327697 · QL2302-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗