NCT05471648已完成1 期
Phase 1, Double-Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Trial of EirGenix' Pertuzumab and Perjeta® (Pertuzumab) Sourced From US and EU Administered to Healthy Male Volunteers
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
- 135
- 试验地点
- 1
- 主要终点
- AUC0-inf of pertuzumab
研究概览
简要总结
This trial is a single-center, single-dose, double-blind, parallel-group, randomized, 3-arm PK trial in healthy male volunteers comparing a biosimilar pertuzumab (EG1206A) to a single intravenous (i.v.) infusion to both European Union (EU) and United States of America (US) reference products.
详细描述
This trial is part of a clinical development program developing a biosimilar pertuzumab, comparing the PK, safety and tolerability and immunogenicity of pertuzumab after a single intravenous (i.v.) infusion.
It assess the bioequivalence, PK characteristics, safety and tolerability as well as the immunogenicity of a test preparation containing 420 mg pertuzumab (EG1206A EirGenix Pertuzumab) as compared to marketed reference (EU and US) after a single dose i.v. infusion over 60 minutes in fasted state.
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)
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
- •aged 18 to 55 years
- •overtly healthy as determined by medical evaluation
- •Body weight of at least 50 kg and not higher than 105 kg at screening
- •BMI above/equal to 18.0 and below/equal to 30.0 kg/m2 at screening
- •Agrees to the following during the treatment period and until 3 months after administration:
- •Be and remain abstinent from heterosexual intercourse OR agree to use a male condom and female partners of childbearing potential must use an additional highly effective contraceptive method
- •Abstain from donating sperm.
- •Signed informed consent
- •Valid COVID-19 immunization status as per current regulations
排除标准
- •History or evidence of any clinically relevant disease, as judged by the investigator
- •Any medical disorder, condition, or history of such that would impair the participant's ability to participate or complete this trial in the opinion of the investigator
- •Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the IMP will not be normal
- •Known or suspected hypersensitivity to the IMPs (active substances, or excipients of the preparations)
- •Known severe allergies e.g., allergies to more than 3 allergens
- •Relevant diseases within the last 4 weeks before IMP administration
- •Febrile illness within 2 weeks before IMP administration.
- •History of known or suspected malignant tumors
- •Known or suspected disorder of the liver
- •Use of systemic/topical medicines/substances which oppose the trial objectives, or which might influence them within 4 weeks before IMP administration
- •Regular use of therapeutic or recreational drugs or supplements
- •Use of any herbal products or St. John's wort from 4 weeks before IMP administration
- •Prior treatment with pertuzumab
- •History of alcohol or drug abuse
- •Regular daily consumption of more than 500 mL of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form
- •Intake of alcohol containing food and beverages from 48 h prior to admission to the ward
- •Regular daily consumption of more than 1 L of methylxanthine-containing beverages
- •Excluded physical therapies that might alter the PK or safety results of the trial from 7 days before IMP administration until follow-up
- •Strenuous physical exercise or sauna visit with 72 h before admission to the ward
- •Donation of more than 100 mL of whole blood or plasma within 4 weeks or approximately 500 mL whole blood within 3 months before IMP administration
- •Plasmapheresis within 3 months before IMP administration
- •Previous or concomitant participation in another clinical trial with IMP(s)
- •Clinically relevant findings in the ECG
- •LVEF below 55%
- •Systolic blood pressure below 100 mmHg or above 140 mmHg
- •Diastolic blood pressure below 50 mmHg or above 90 mmHg
- •Heart rate below 50 beats/ min or above 90 beats/min
- •Clinically relevant findings in the physical examination that may affect the objectives of the trial, or the safety of the participant
- •Poor venous access
- •Clinically relevant deviations of the screened safety laboratory parameters
- •Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, gamma glutamyl transpeptidase, or total bilirubin above 1.2 upper limit of normal
- •Thyroid disorders as evidenced by assessment of thyroid stimulating hormone (TSH) level outside the normal reference range
- •Positive results for hepatitis B virus surface antigen, hepatitis C virus antibodies, human immune deficiency virus antibodies, and human immune deficiency virus antigen
- •Positive urine drug test
- •Positive alcohol test
- •Positive cotinine test
- •Any criteria which, in the opinion of the investigator, preclude participation for scientific reasons, for reasons of compliance, or for reasons of the participant's safety
- •Close affiliation with the investigational site
- •Vulnerable participants who are e.g., institutionalized due to regulatory or juridical order dependent on sponsor, site, or investigator or not able to consent, respectively.
- •History of COVID-19 within 2 months prior to screening
- •Long COVID-19 syndrome or other clinically relevant COVID-19 related symptoms or sequelae
- •Positive SARS-CoV-2 viral ribonucleic acid (RNA) test at admission
- •No SARS-CoV-2 vaccinations should be booked within 14 days before IMP administration and until last trial visit.
研究组 & 干预措施
420 mg EirGenix Pertuzumab
Experimental
EirGenix Pertuzumab given intravenous with an infusion bag as a single dose of 420 mg over 60min.
干预措施: 420 mg EG1206A EirGenix Pertuzumab in 14 mL Injection (Drug)
420 mg Pertuzumab Perjeta EU Origin
Active Comparator
EU Pertuzumab given intravenous with an infusion bag as a single dose of 420 mg over 60min.
干预措施: Perjeta (EU origin) 420 mg in 14 mL Injection (Drug)
420 mg Pertuzumab Perjeta US Origin
Active Comparator
US Pertuzumab given intravenous with an infusion bag as a single dose of 420 mg over 60min.
干预措施: Perjeta (US origin) 420 mg in 14 mL Injection (Drug)
结局指标
主要结局
AUC0-inf of pertuzumab
时间窗: Pre-dose to day 91, 21 timepoints
Area under the plasma concentration-time curve, from time 0 h extrapolated to infinity
次要结局
- Cmax(Pre-dose to day 91, 21 timepoints)
- Drug clearance (CL)(Pre-dose to day 91, 21 timepoints)
- tmax(Pre-dose to day 91, 21 timepoints)
- t1/2(Pre-dose to day 91, 21 timepoints)
- Volume of distribution (Vd)(Pre-dose to day 91, 21 timepoints)
- AUC0-last of pertuzumab(Pre-dose to day 91, 21 timepoints)
- Frequency of treatment-emergent adverse events (AEs)(Day 1 to day 91)
- Immunogenicity: Anti-drug antibodies (ADA) and neutralizing antibodies (NAb)(Pre-dose to day 91, 7 timepoints)
研究者
研究点 (1)
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