一项1期比较研究，旨在评估健康男性志愿者单次皮下注射600 mg Bmab3000和Herceptin Hylecta®后的药代动力学、免疫原性、安全性和耐受性
一项评估Bmab3000与赫赛汀Hylecta®在健康男性志愿者中单次皮下注射600 mg后的药代动力学、免疫原性、安全性及耐受性的1期、随机、双盲、双臂、平行设计的比较研究
This phase I study is to compare the pharmacokinetics (PK), immunogenicity, safety, and tolerability of Bmab3000 (test) and Herceptin Hylecta (reference) after a single subcutaneous (s.c.) dose in healthy male volunteers.
研究概览
详细说明
This is a Phase 1, randomized, double-blind, two-arm, parallel-group trial comparing the pharmacokinetics (PK), immunogenicity, safety, and tolerability of Bmab3000 (test) and Herceptin Hylecta (reference) after a single subcutaneous (s.c.) dose.
A total of 150 healthy male participants (75 per arm) will be enrolled to ensure 138 evaluable subjects. Participants will be randomized in 1:1 using stratified block randomization based on baseline body weight (≥50-≤75 kg and >75-≤100 kg).
Each participant will be involved in the study for approximately four months, which includes one screening visit, a 3-night inpatient stay, and 16 scheduled outpatient follow-up visits. Participants will attend a screening visit (Day -28 to Day -1) to confirm eligibility. This will include obtaining informed consent, medical history, physical examination, vital signs, biometric measurements, ECG, echocardiogram, and blood and urine tests, as well as drug and alcohol screening. Eligible participants will be admitted to the study site on Day -1 for pre-dose assessments to confirm continued eligibility. On Day 1, participants will receive a single subcutaneous injection of either Bmab3000 or Herceptin Hylecta. During the inpatient stay (Days -1 to 3), participants will undergo continuous safety monitoring, including regular vital signs, ECGs, injection site checks, and blood sampling for pharmacokinetic, safety, and immunogenicity assessments. After discharge, participants will return for outpatient visits till Day 85 for continued safety monitoring, blood sampling for pharmacokinetic and immunogenicity analyses, and ECGs and vital sign assessments. The final visit on Day 91 will include a full physical examination, echocardiogram, ECG and blood sampling for pharmacokinetic & immunogenicity analyses and final laboratory evaluations.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
-
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Main Building: 264 Antigua Street,
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Christchurch、Main Building: 264 Antigua Street,、新西兰
- New Zealand Clinical Research (NZCR)
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy male volunteers aged between 18 to 65 years; both inclusive.
- Body weight ≥50 kg and ≤100 kg with body mass index (BMI) between 18.5 and 30 kg/m2, both inclusive.
- Participants should have Left ventricular ejection fraction (LVEF) ≥55%.
- Male participants must be using an acceptable method of contraception for the entire duration of the trial, and for at least three months after the trial drug administration. Participants must refrain from fathering a child or donating sperm in the next three months following the last trial drug administration or undergoing vasectomy.
- All non-prescription medications must have been discontinued at least 14 days prior to dosing.
- All non-topical prescription medications must have been stopped at least 30 days prior to admission to the clinical research center.
- Absence of significant findings in the vital signs, 12 lead ECG, and clinical laboratory tests of blood and urine.
- Willing and able to sign the informed consent form (ICF).
Exclusion Criteria:
- History of previous exposure to trastuzumab.
- Presence of clinically significant medical history and clinically significant findings in the physical examination.
- Allergy or hypersensitivity to trastuzumab, other recombinant human or humanized antibodies, other related products, or any excipients/ ingredients (e.g. hyaluronidase).
- Sick sinus syndrome or known long QT syndrome (QTcF >450 msec).
- Pronounced sinus bradycardia (<40 bpm), even if elicited by sport.
- History of relevant drug and/or food allergies.
- Positive urine drug and breath alcohol screen.
- Consumption of any foods containing poppy seeds within 48 hours (2 days) prior to screening/admission to the clinical research center.
- Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis virus (HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 and 2 antibodies.
- Donation or loss of blood prior to drug administration.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Bmab3000
Single s.c. dose of Bmab3000 containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL |
Single s.c. dose of Herceptin Hylecta containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL |
|
有源比较器：Herceptin Hylecta®
Single s.c. dose of Herceptin Hylecta containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL |
Single s.c. dose of Bmab3000 containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cmax
大体时间：Day 1 to Day 91
|
Maximum observed concentration (Cmax) of drug Bmab 3000 |
Day 1 to Day 91
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AUCo-∞
大体时间：Day 1 to Day 91
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Comparison of area under the concentration-time curve from time 0 to infinity (AUC0-inf) |
Day 1 to Day 91
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
AUCo-t
大体时间：Day 1 to Day 91
|
Area Under the serum Concentration versus time curve from time 0 to the last sampling time at which concentrations were at or above the limit of quantification |
Day 1 to Day 91
|
|
Tmax
大体时间：Day 1 to Day 91
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Time to maximum observed concentration |
Day 1 to Day 91
|
|
Vd/F
大体时间：Day 1 to Day 91
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Volume of distribution |
Day 1 to Day 91
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Cl/F
大体时间：Day 1 to Day 91
|
drug clearance |
Day 1 to Day 91
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t1/2
大体时间：Day 1 to Day 91
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Apparent terminal elimination half-life |
Day 1 to Day 91
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|
AUC% extrapolation
大体时间：Day 1 to Day 91
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% of the AUC that has been derived after extrapolation |
Day 1 to Day 91
|
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λz
大体时间：Day 1 to Day 91
|
Elimination rate constant |
Day 1 to Day 91
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Safety_ Adverse Reactions
大体时间：Baseline to Day 91
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Adverse Events and Adverse Reactions during the Treatment Period |
Baseline to Day 91
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Safety_ Injection-site Reactions
大体时间：Day 1 to Day 91
|
Injection-site Reactions |
Day 1 to Day 91
|
|
Immunogenicity
大体时间：Day 1 to Day 91
|
Developing Antidrug Antibodies |
Day 1 to Day 91
|
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Immunogenicity
大体时间：Day 1 to Day 91
|
Developing Neutralizing Antibodies |
Day 1 to Day 91
|
合作者和调查者
调查人员
- 首席研究员：Dr Cory Sellwood, MBBS、New Zealand Clinical Research (NZCR) Main Building: 264 Antigua Street, Christchurch, New Zealand
- 首席研究员：Dr Leanne Barnett, MBBS、New Zealand Clinical Research (NZCR) Main Building: 3 Ferncroft Street, Grafton, Auckland, New Zealand
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- BIO-TRASTU-103
- U1111-1329-7865 (其他标识符：World Health Organization (WHO))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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