A randomized, double-blind, single-dose, Phase I, parallel group study tocompare the pharmacokinetics, safety, tolerability, and immunogenicity oftrastuzumab from three subcutaneous (SC) injection formulations: the testproduct (Zercepac 600 mg) and the reference products (EU-sourced Herceptin600 mg and US-sourced Herceptin Hylecta 600mg) in healthy adult malesubjects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- To compare the pharmacokinetic (PK) parameters of Zercepac
研究概览
简要总结
This is a study to compare the pharmacokinetics, safety, tolerability, and immunogenicity of trastuzumab from three subcutaneous (SC) injection formulations: the test product (Zercepac 600 mg) and the reference
products (EU-sourced Herceptin 600 mg and US sourced Herceptin Hylecta 600mg) in healthy adult male subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Male
入选标准
- •Non-smoking, healthy adult male subjects between 18 and 55 years of age (both inclusive) 2) Having a body weight between 50 kg and 94.9 kg (both inclusive) and body mass index (BMI) between 18.5 and 30.0 kg per m2 (both inclusive); calculated as weight in kg per height squared in meters (BMI equal to kg per m2).
- •Stratification will be done based on weight to less than or equal to 70 kg and greater than 70 kg.
- •Not having any clinically significant disease or clinically significant abnormal findings (Investigator discretion) during screening based on medical history, physical examination, vital signs measurement (pulse rate, blood pressure, respiratory rate, and body temperature), laboratory evaluations, and cardiac markers (N-terminal pro-brain natriuretic peptide, HS Trop I), 12-lead ECG, left ventricular ejection fraction (LVEF) greater than 55 percentage by echocardiogram (2D Echo), TMT, and chest Xray (P A view; within the last 6 months).
- •Has the willingness to adhere to the protocol requirements.
- •Capable of communicating effectively with study personnel 6) Able to understand and comply with the study procedures, as per the opinion of the investigator.
- •Able to give voluntary written informed consent for participation in the trial.
- •Subjects willing to use a barrier method (condoms) of contraception during the study and for 7 months after dosing in the study.
- •Subject should not be donating semen during the study and for 7 months after dosing.
排除标准
- •Known hypersensitivity or idiosyncratic reaction to trastuzumab or its constituents.
- •History or presence of any disease or disorder known to compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- •Clinically significant illness within four (4) weeks prior to initial dosing or symptoms or signs suggestive of any infection 4) Any clinically significant abnormal laboratory findings at the discretion of the investigator at the time of screening 5) Any history or presence of asthma (including aspirin-induced asthma) or nasal polyp or NSAID-induced urticaria.
- •Donation of blood (1 unit or 350 mL) or Receipt of an investigational medicinal product or participation in a drug research study within a period of 180 days prior to the dose of study medication.
- •If investigational medicinal product is received within 180 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received.
- •If involved in a drug research study with an investigational medicinal product which is a monoclonal antibody or fusion protein then, 12 months.
- •Smokers, or who have smoked within last six months prior to start of the study.
- •Ingestion or use of a medicine (prescribed and over the counter (OTC) medication including herbal remedies at any time within 1 month prior to dosing, any vaccine (including COVID- 19 vaccine) from 14 days prior to receiving the IMP; live vaccine(s) within 30 days prior to dosing).
- •In any such case subject selection will be at the discretion of the Investigator.
- •Subject with history of untreated hypertension or systolic BP of greater than 140 mmHg and diastolic BP of greater than 90 mmHg at the time of screening (reconfirmed at check-in).
- •A recent history of harmful use of alcohol (less than 2 years), i.e., alcohol consumption of more than 14 standard drinks per week (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 mL of 40 percentage distilled spirits, such as rum, whisky, brandy, etc.) or consumption of alcohol or alcoholic products within 72 hours prior to receiving the study drug.
- •History of drug addiction or testing positive for drugs-of-abuse at screening.
- •Positive result for human immunodeficiency virus (HIV 1 and or 2) and or hepatitis screen including HBsAg, Anti HBc IgM and HCV antibodies tests.
- •History or presence of any psychiatric disorders 14) History of any clinically significant lung disease.
- •History of cancer including lymphoma, leukemia, and skin cancer.
- •History of surgery or major trauma within 12 weeks prior to receiving study drug or surgery planned during the study.
- •History of congestive heart failure 18) Presence of tattoos or scars or any type of skin lesions due to infection, burn, wound or inflammation at the proposed site of dosing.
- •Previously received any monoclonal antibody or fusion protein for treatment purpose.
- •History of participation in a clinical study of a monoclonal antibody or fusion protein in the past 12 months.
- •An unusual diet, for whatever reason (e.g., low-sodium), for 4 weeks prior to receiving the study medicine.
- •Consumption of citrus fruits (including grapefruit or grapefruit products) and or apple or pineapple within 72 hours prior to receiving study drug.
- •A history of difficulty with donating blood or veins unsuitable for collection.
结局指标
主要结局
To compare the pharmacokinetic (PK) parameters of Zercepac
时间窗: at 0 hours (pre-dose), at 2 hours, 4 hours, | 6 hours, 12 hours, 24 hours (Day 2), 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), | 96 hours (Day 5), 120 hours (Day 6), 144 hours (Day 7), 168 hours (Day 8), 192 hours (Day | 9), 216 hours (Day 10), 240 hours (Day 11), 264 hours (Day 12), 288 hours (Day 13), 312 | hours (Day 14), 336 hours (Day 15), 360 hours (Day 16), 408 hours (Day 18), 480 hours (Day | 21), 600 hours (Day 26), 720 hours (Day 31), 840 hours (Day 36), 1008 hours (Day 43), 1344 | hours (Day 57), and 1680 hours (Day 71) after the start of injection
600 mg SC (T) with that of EU-sourced Herceptin® 600 mg SC (R1)
时间窗: at 0 hours (pre-dose), at 2 hours, 4 hours, | 6 hours, 12 hours, 24 hours (Day 2), 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), | 96 hours (Day 5), 120 hours (Day 6), 144 hours (Day 7), 168 hours (Day 8), 192 hours (Day | 9), 216 hours (Day 10), 240 hours (Day 11), 264 hours (Day 12), 288 hours (Day 13), 312 | hours (Day 14), 336 hours (Day 15), 360 hours (Day 16), 408 hours (Day 18), 480 hours (Day | 21), 600 hours (Day 26), 720 hours (Day 31), 840 hours (Day 36), 1008 hours (Day 43), 1344 | hours (Day 57), and 1680 hours (Day 71) after the start of injection
and US-sourced Herceptin® Hylecta 600mg SC (R2)
时间窗: at 0 hours (pre-dose), at 2 hours, 4 hours, | 6 hours, 12 hours, 24 hours (Day 2), 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), | 96 hours (Day 5), 120 hours (Day 6), 144 hours (Day 7), 168 hours (Day 8), 192 hours (Day | 9), 216 hours (Day 10), 240 hours (Day 11), 264 hours (Day 12), 288 hours (Day 13), 312 | hours (Day 14), 336 hours (Day 15), 360 hours (Day 16), 408 hours (Day 18), 480 hours (Day | 21), 600 hours (Day 26), 720 hours (Day 31), 840 hours (Day 36), 1008 hours (Day 43), 1344 | hours (Day 57), and 1680 hours (Day 71) after the start of injection
次要结局
- To compare the immunogenicity of Zercepac 600 mg SC (T) with(that of EU-sourced Herceptin 600 mg SC (R1) and US-sourced)
- To compare the safety and tolerability of Zercepac 600 mg SC (T)(with that of EU-sourced Herceptin 600 mg SC (R1) and USsourced)