NCT04175171已完成1 期
A Randomized, Double-blind, Parallel-group, Comparative Phase I Study to Evaluate the Safety and Pharmacokinetics of Single Intravenous (IV) Administration of GB221 Versus Herceptin® (Trastuzumab)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- physical examination
研究概览
简要总结
The primary objective is to assess the safety of a single dose of GB221 compared to Herceptin® when administered as a single IV injection at a dose of 8 mg/kg. The secondary objective of the study is to assess the pharmacokinetics of GB221 compared to Herceptin®.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •To be enrolled in the study, subjects must meet the following criteria
- •Males aged 18 to 45 years.
- •Healthy as judged by medical examination and medical history, and clinical chemistry and hematology screening.
- •Body weight within the normal range for height (BMI between 19.0 and 29.0, inclusive) up to a maximum of 90 kg.
- •Normal or non-clinically significant ECG.
- •Normotensive (systolic: 90 - 140; diastolic: 50 - 90 mm Hg, inclusive) and heart rate (40 -100 bpm, inclusive).
- •Willingness to give written and informed consent prior to any studyrelated procedures being conducted
排除标准
- •Subjects will be ineligible for the study if any of the following criteria apply:
- •Receipt of any investigational agent or drug within 4 weeks of entry to the study.
- •Use of any medicine - prescription, over-the-counter or herbal - in the 7 days prior to the treatment day and until 12 weeks after the treatment day.
- •Donation of blood (or loss of blood) greater than 400 ml within 3 months of the study.
- •Clinically significant drug allergy or sensitivity to any medication.
- •A history of chronic or recurrent infections.
- •A recent history of surgery.
- •History or presence of malignancy (with the exception of successfully treated basal cell carcinoma).
- •Inability to communicate or cooperate with the Principal Investigator because of English language difficulties or poor mental development.
- •A history (within the last 5 years) or evidence of alcohol or drug abuse (excepting tobacco use less than 10 cigarettes per day).
- •A positive urine test for drugs of abuse or alcohol either at screening or on the day of admittance for drug administration.
- •Vaccination of any type within the previous month.
- •A history of major psychiatric illness (such as bipolar disorder, schizophrenia or persistent major depression). Previous minor depression/adjustment disorder is acceptable if currently asymptomatic.
- •Consumption of more than 3 standard drinks per day, and not able to abstain from alcohol totally within 24 hours of dose administration.
- •Presence of current infection with tuberculosis, Hepatitis B, Hepatitis C or HIV.
- •History of asthma or other chronic respiratory disease in the past 5 years.
- •History of neurological or neuromuscular disease.
- •History of hypertension or cardiovascular disease, including congestive heart failure and cardiomyopathy or a clinically significant echocardiogram finding at the screening visit.
- •History of bladder or urethral disease.
- •Smoking cigarettes > 10 per day.
- •Any other condition which in the view of the Principal Investigator is likely to interfere with the study or put the subject at risk.
研究组 & 干预措施
GB221
Experimental
Coprelotamab Injection, 8mg/kg, single dose
干预措施: Coprelotamab Injection (Drug)
Herceptin
Active Comparator
Trastuzumab Injection, 8mg/kg, single dose
干预措施: Trastuzumab Injection (Drug)
结局指标
主要结局
physical examination
时间窗: Up to 84 days
physical examination
heart rate
时间窗: Up to 84 days
heart rate
respiration rate
时间窗: Up to 84 days
respiration rate
oxygen saturation
时间窗: Up to 84 days
oxygen saturation
adverse event
时间窗: Up to 84 days
adverse event
temperature
时间窗: Up to 84 days
temperature
blood pressure
时间窗: Up to 84 days
blood pressure
次要结局
- CL(Up to 84 days)
- C max(Up to 84 days)
- t max(Up to 84 days)
- AUC(Up to 84 days)
- V(Up to 84 days)
- t ½(Up to 84 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Study Evaluating the Safety and Effects of MN-221 in Subjects With Moderate to Severe AsthmaAsthmaNCT00679263MediciNova17
已完成
4 期
A Double-Blind Comparison of Galantamine HBr and Placebo in Adults With Attention Deficit Hyperactivity DisorderADHDNCT00181675Massachusetts General Hospital40
已完成
2 期
Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition in Japan.InflammationCardiovascular RiskChronic Kidney DiseaseNCT04626505Novo Nordisk A/S36
终止
2 期
A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participants With Moderate to Severe Atopic DermatitisDermatitis, AtopicNCT05999799GlaxoSmithKline161
撤回
2 期
A Randomized,Double Blind, Placebo Controlled Study to Assess Efficacy,Safety and Tolerability of BGG492 in Migraine PreventionPatients With Migraine Equal of /More Than 3 and Equal of/ Less Than 12 Migraine Attacks/4 Weeks for Each of the Last 6 Months Preceding the ScreeningNCT01617941Novartis Pharmaceuticals