NCT05576454已完成1 期
A Randomized, Double-blinded, Single-dose, 3-arm Parallel Comparative Study on Pharmacokinetics and Safety of BAT2606 Injection Versus Mepolizumab Injection (EU-licensed Nucala® and US-licensed Nucala®) in Healthy Chinese Male Subjects
Bio-Thera Solutions1 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2022年9月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
To evaluate the pharmacokinetics, safety and immunogenicity of BAT2606 in healthy China male subjects.
详细描述
This is a single-center, randomized, double-blind, single-dose, parallel three arms comparative study of pharmacokinetics, safety and immunogenicity.
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)
盲法说明
double-blinded design.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects have signed the informed consent before the trial, and fully understood the content, process and relevant risks of the trial.
- •Subjects who are able to complete the study in accordance with the requirements of the protocol.
- •Visiting subjects (including partners) who are willing to comply with the study provisions agree to have no pregnancy plans and no donor sperm plans throughout the trial and for 6 months after dosing, and to voluntarily use effective contraception, as described in Appendix
- •Subjects with BMI between 18 and 28 kg/m2 (both inclusive) and body weight between 55 and 85 kg (both inclusive).
- •Healthy Chinese male subjects between the ages of 18 and 55 years (both inclusive).
- •Subjects with normal or abnormal physical examinations without clinical significance.
排除标准
- •Subjects who have clinically significant abnormalities in clinical laboratory tests.
- •Subjects with clinical significance of abnormal ECG, chest x-ray.
- •Subjects with history of hypertension.
- •Subject who are or had been suffering from malignant neoplasm; subject who are or had been suffering from inflammatory bowel disease.
- •Subjects who have an active infection within 2 months prior to screening, including acute and chronic infections as well as localized infections.
- •Subjects who have active tuberculosis.
- •Subjects who have been exposed to TB within 3 months prior to screening.
- •Subjects whose T-cell test for tuberculosis infection (T-SPOT.TB) results are positive.
- •Subjects who are positive for HBsAg on the hepatitis B half test.
- •Subjects who have had a major injury or undergone previous surgical procedures or fracture within 4 weeks prior to enrollment.
- •Subjects who have taken any prescription medication within 28 days prior to screening.
- •Subjects who participate in another drug clinical trial within 3 months prior to enrollment.
- •Subjects who suffered an acute illness from the screening period until study drug administration.
- •Subjects who have received Mepolizumab (or its biosimilar) within 6 months (or within 5 half-lives of the drug, whichever is longer) prior to screening.
- •Subjects who have received live vaccination during the study period within 12 weeks prior to study dosing.
- •Subjects who are suspected or confirmed to be allergic (allergic to multiple medications or foods).
- •Subjects who smoked more than 5 cigarettes per day in the 3 months prior to screening.
- •Subjects who have taken any alcohol-containing product within 24h prior to study dosing.
- •Subjects who have donated blood or lost a significant amount of blood (> 450 mL) within 3 months prior to study drug administration.
- •Subjects with a positive urine drug screening.
- •Subject who is deemed unsuitable for enrollment by the investigator.
研究组 & 干预措施
BAT2606 Injection
Experimental
PFS, Strength: 100 mg/1 mL, 100 mg, Subcutaneous injection.
干预措施: Mepolizumab Injection (BAT2606 Injection) (Drug)
Mepolizumab Injection (EU-licensed Nucala®)
Active Comparator
PFS, Strength: 100 mg/1 mL, 100 mg, Subcutaneous injection.
干预措施: Mepolizumab Injection (EU-licensed Nucala) (Drug)
Mepolizumab Injection (US-licensed Nucala®)
Active Comparator
PFS, Strength: 100 mg/1 mL, 100 mg, Subcutaneous injection.
干预措施: Mepolizumab Injection (US-licensed Nucala) (Drug)
结局指标
主要结局
Cmax
时间窗: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
Maximum blood concentration
AUC0-∞
时间窗: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
Area under the plasma concentration-time curve from zero to infinity, AUC0-∞ = AUC0-t + Ct/λz
次要结局
- λz(Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113)
- Tmax(Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113)
- Vd(Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113)
- AUC0-t(Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113)
- t1/2(Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113)
- CL/F(Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113)
- Adverse events(Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113)
- Immunogenicity(Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113)
研究者
研究点 (1)
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