EUCTR2017-001634-26-Outside-EU/EEA进行中（未招募）1 期
Phase I, Double Blind, Randomized, Parallel-Arm, Single-Dose, Pharmacokinetic and Safety Study of Bevacizumab-biosimilar (RPH-001) Compared to Bevacizumab-innovator (Avastin®, Roche) in Healthy Male Volunteers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- TRPHARM
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •I-1.Healthy male subjects aged 18 to 55 years inclusive.
- •I-2.Adult healthy male subjects between 18.0 and 30.0 kg/m2 body mass index (inclusive) and body weight = 60 kg and = 100 kg (inclusive).
- •I-3.Certified as healthy by a comprehensive clinical assessment (detailed medical history [hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 3 weeks prior start of the trial, registration of life style and habits such as consumption of alcohol, nicotine, coffee, tea, coke, special diet, drug abuse]) and complete physical examination (general state and abnormal findings per system: endocrine/metabolic, allergies, drug sensitivities, head, neck, eyes, ears, nose, throat, cardiovascular, respiratory, gastrointestinal, hepatic/biliary, urogenital, musculoskeletal, Lymph nodes, skin, and neurological/psychiatric).
- •I-4.Normal vital signs after 10 minutes resting in supine position:
- •90 mmHg < systolic blood pressure (SBP) <140 mmHg
- •45 mmHg < diastolic blood pressure (DBP) <90 mmHg
- •40 bpm < heart rate (HR) <100 bpm
- •I-5.Normal standard 12-lead electrocardiogram (ECG) after 10 minutes resting in supine position in the following ranges; 120 msI-6.Subjects whose clinical laboratory test results are normal, or where outside the reference range is judged as not clinically relevant by the Investigator
- •I-7.Having given written informed consent prior to undertaking any study-related procedure.
- •I-8.Negative Quantiferon TB gold test.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •E-1.Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
- •E-2.Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
- •E-3.Blood or plasma donation, or transfusion with any volume, within 3 months before inclusion.
- •E-4.Symptomatic hypotension, irrespective of the decrease in blood pressure.
- •E-5.Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
- •E-6.Major surgery including appendectomy with in last 12 weeks.
- •E-7.History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day).
- •E-8.Current smoker of more than 5 cigarettes or equivalent per day during the study and unable to completely stop smoking during the hospitalization.
- •E-9.Excessive consumption of beverages containing xanthine bases such as tea, coffee, coke etc. (more than 500 mg xanthine per day).
- •E-10.Medication with drugs known to alter organs or systems such as barbiturates, phenothiazines, cimetidine, omeprazole etc. within the last 2 months.
- •E-11.Any medication (including St John’s Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.
- •E-12.Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
- •E-13.Any subject in the exclusion period of a previous study according to applicable regulations.
- •E-14.Any subject who cannot be contacted in case of emergency.
- •E-15.Any subject who is the Investigator or any Sub-investigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in conducting the study.
- •E-16.Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
- •E-17.Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
- •E-18.Positive alcohol test at screening or baseline visits
- •E-19.Any contraindications to biological molecules according to the applicable labeling.
- •E-20.Vegetarian diet
- •E-21.Participation in another clinical trial at same time or within the preceding 3 months (calculated from the date of the final examination of the previous study), except for previous BE trials in which case 8 weeks are sufficient.
研究者
相似试验
进行中（未招募）
1 期
Phase I, Pharmacokinetic, Safety and Tolerability Study in Healthy Volunteers to Evaluate Bioequivalence of LusiNEX and Tocilizumab (EU and US)Elevated liver enzymesneutropeniaInflammatory and Immune System - Rheumatoid arthritisthrombocytopeniaACTRN12618000859280Mycenax Biotech Inc.190
招募中
1 期
Study of M5049 in DM and PM Participants (NEPTUNIA)CTIS2022-501351-82-00Merck Healthcare KGaA41
已完成
不适用
A Phase 1, Randomized, Double-Blind, Two-Arm, Placebo-Controlled, Single and Multiple Dose Escalation Study to Assess the Safety and Tolerability of LJPC-401 in Healthy Adultssickle cell diseasehereditary haemochromatosismyelodysplasia (MDS)thalassemiaACTRN12617000689370a Jolla Pharmaceutical Australia Pty Ltd, an affiliate of La Jolla Pharmaceutical Company36
已完成
不适用
Phase I, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Single Dose Study to Evaluate the Blockade of CGRP Receptor by AMG 334 in Preventing PACAP-38 Induced Migraine-like Attacks in Migraine Patients10019231migraineNL-OMON45872Amgen50
已完成
2 期
A Phase IIa, Randomised, Parallel, Double-Blind,Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MEDI0382 in Japanese Preobese or Obese Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control with Diet and ExerciseType 2 DiabetesJPRN-jRCT2080224025AstraZeneca KK60