jRCT2080225005已完成1 期
A Randomised, Double Blind, Two-Arm, Single Dose, Parallel Phase I Study To Compare the Pharmacokinetics, Safety and Immunogenicity of MB02 (a proposed bevacizumab biosimilar drug) and EU-approved Avastin in Japanese Healthy Male Volunteers
mAbxience Research S.L.1 个研究点目标入组 48 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- AUC(0-inf)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Randomized (1:1), double blind, single-dose, two arms, parallel phase 1 study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 55age old under（—）
- 性别
- Male
入选标准
- •Subjects with Body mass index (BMI) between =>18.5 to =<28 kg/m2 and total body weight between =>50 and =<100 kg, at Screening
- •Systolic blood pressure =<140 mm Hg and diastolic blood pressure =<90 mm H g.
- •Computerized (12-lead) ECG recording without signs of clinically relevant pathology.
- •All other values for hematology, coagulation and for biochemistry and urinalysis tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the Investigator, according to the laboratory values from study value.
- •Ability and willingness of accordance with limitation rules in the study period.
排除标准
- •History of bleeding disorders or protein C, protein S, and/or factor V Leiden deficiency
- •Known history of clinically significant essential hypertension (subjects under any
- •antihypertensive treatment included), orthostatic hypotension, fainting spells or
- •blackouts for any reason, cardiac failure or history of thromboembolic conditions
- •History of GI perforation, ulcers, gastro-oesophageal reflux, inflammatory bowel
- •disease, diverticular disease, diverticular disease, any fistulae, pulmonary hemorrhage
- •(hemoptysis) or reversible posterior leukoencephalopathy syndrome
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological,
- •hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal,
- •neurological, respiratory, endocrine, or psychiatric disorder, as determined by the
- •Investigator (or designee)
- •Any current or recent history of active infections, including localized infections.
结局指标
主要结局
AUC(0-inf)
To demonstrate pharmacokinetic similarity, as primary assessed by the Area Under the Concentration-time curve extrapolated to infinity (AUC(0-inf)) between the two study arms, MB02 and EU-Avastin
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
Unknown
Bioequivalence clinical trial to compare PK parameters and safety of Factor VIII, recombinant human with Fc fusion (rFVIII-Fc) (Coageight, produced by AryoGen Pharmed Company) versus Elocta® in previously treated patients with severe hemophilia ASevere hemophilia A.Symptomatic hemophilia A carrierZ14.02IRCT20150303021315N31AryoGen Company50
招募中
1 期
This is a randomized, double-blind, two-arm, single-dose, parallel-group study in normal healthy adult male volunteers.CTRI/2024/02/063265Biocon Biologics UK Limited
尚未招募
Unknown
A Single Dose Two-Way Crossover Oral Bioavailability Study Of The Study Product (BerbiQ) Which Contains Berberine, In Healthy, Adult, Human Subjects Under Fasting Conditions.CTRI/2024/07/070781Molecules Biolabs Pvt Ltd
尚未招募
Unknown
A Single Dose, Two-Treatment,Oral Bioavailability Study Of the Product Containing VitaminC in Healthy, Adult, Human Subjects Under Fasting Conditions.CTRI/2024/07/070710Molecules Biolab Pvt Ltd
招募中
1 期
StudyEvaluating the(PK),(PD), Safety,andImmunogenicity between BSC-0826 and US-licensed Neulasta and EU-approvedNeulasta Part 1, and Evaluating the Safety and Immunogenicity in Part 2 of BSC-0826 to EU-Neulasta�®following Subcutaneous Administration to Healthy SubjectsCTRI/2021/10/037600Veeda Clinical Research