ACTRN12618000859280进行中（未招募）1 期
Phase I, Double-Blind, Randomized, Three-Arm, Parallel-Group, Pharmacokinetic, Safety and Tolerability Study in Healthy Volunteers to Evaluate Bioequivalence of LusiNEX and Tocilizumab (EU and US)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 190
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1. Willing to provide written informed consent prior to performing study-related
- •procedures.
- •2. Healthy male or female aged between 18 to 55 years, inclusive.
- •3. A body mass index between 18 to 30 kg/m2, inclusive.
- •4. Medically healthy with clinically insignificant results (e.g., medical history,
- •electrocardiograms [ECGs], and physical examination) as judged by the Principal
- •Investigator at Screening/Day 1 (admission to study center).
- •5. All laboratory results including, but not restricted to, complete blood counts, liver
- •function, and lipid profile should be within the normal range or clinically
- •insignificant as judged by the Investigator at Screening/Day 1 (admission to study
- •center). An abnormal laboratory result considered to be erroneous, may be repeated
- •once during Screening at the discretion of the Investigator.
- •6. Have systolic blood pressure less than or equal to 140 and greater than or equal to 90 mmHg, diastolic blood pressure less than or equal to 90 and greater than or equal to 50 mmHg, and a heart rate greater than or equal to 40 and less than or equal to 100 beats per minute at Screening/Day 1 (admission to study center).
- •7. Has to agree to abstain from alcohol intake 48 hours before administration of the
- •study drug and during the inpatient period of the study.
- •8. Negative urine drug screen/alcohol breathylzer test at Screening/Day 1 (admission to
- •study center).
- •9. Non-smokers or social smokers (defined as less than 10 cigarettes per week). No
- •current use of any nicotine containing product. Cotinine levels =5 ng/mL.
- •10. Willing to abstain from sexual intercourse or use 2 methods of contraception (both
- •male and female partners) as defined in the protocol for 3 months after study drug
- •administration.
- •Female subjects who are using oral hormonal contraceptives must be willing to use,
- •with their partner, 2 methods of contraception as defined as defined in the protocol.
- •11. Has to agree to not donate sperm or ova for at least 3 months after study drug
- •administration.
- •12. Subjects who are negative for hepatitis B surface antigen, hepatitis B core antibody,
- •hepatitis C antibodies, human immunodeficiency virus I and II, as well as tuberculosis
- •(TB) tests at Screening.
- •13. Did not receive a blood transfusion within 4 weeks prior to study drug administration,
- •donate 400 mL or more blood within 8 weeks prior to study drug administration or
- •donate plasma within 4 weeks prior to study drug administration and agrees to not make blood donations, including red blood cells, plasma, platelets, or whole blood for the duration of the study and for 3 months after study drug administration.
- •14. Able to be compliant with the protocol and attend all scheduled visits.
- •15. Has to agree to not consume any caffeine and/or xanthine products from 24 hours before admission to the study center until 48 hours after study drug administration.
- •16. Not have consumed grapefruit and/or grapefruit containing products, Seville oranges or quinine (tonic water) from 24 hours before admission to the study center until after the last sample has been collected for the study.
排除标准
- •1. Volunteers with any known active current or history of recurrent bacterial, viral,
- •fungal, mycobacterial or other infections.
- •2. Have been treated with IV antibiotics for an infection within 8 weeks or oral
- •antibiotics within 2 weeks prior to Screening.
- •3. History of TB infection, active TB or latent TB infection, or recent exposure to a
- •person with active TB.
- •4. Previous exposure to therapeutic monoclonal antibodies in the past 6 months prior to
- •5. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
- •antibodies.
- •6. A history of clinically significant gastrointestinal, renal, hepatic, cardiovascular,
- •or allergic disease.
- •7. Evidence of active malignant disease, malignancies diagnosed within the previous 2
- •years (except basal cell carcinoma of the skin that has been excised and cured), or
- •breast cancer diagnosed within the previous 2 years.
- •8. Impaired liver function as determined by:
- •Serum alanine aminotransferase and/or aspartate aminotransferase >1.5 x upper limit
- •of normal (ULN) at Screening or admission to the study center. Subjects with values
- •between ULN and 1.5 x ULN may be included in the study if considered not clinically
- •significant by the Investigator.
- •9. Current or past history of diverticulitis or biliary obstruction.
- •10. Presence of proteinuria (other than trace amounts i.e., +, ++/+++) at Screening or
- •admission to the study center.
- •11. Administration of an investigational product in another study within 30 days or 5
- •half-lives of the investigational drug (whichever is longer) prior to screening, or
- •are currently participating in another clinical study of an investigational drug, or
- •intending to participate in another clinical study of an investigational drug before
- •completion of all scheduled evaluations in this clinical study.
- •12. Use of any prescription or over-the-counter medication (with the exception of
- •contraceptive medication in females and paracetamol) within 7 days of Screening and
- •for the duration of participation in the study. This includes the use of any NSAIDs
- •(including aspirin) within 28 days before study drug administration and for the
- •duration of participation in the study.
- •13. Intake of herbal drugs or dietary supplements excluding routine vitamins but including
- •megadose (intake of 20 to 600 times the recommended daily dose) vitamin therapy within
- •28 days prior to study drug administration, unless agreed as not clinically relevant
- •by the Investigator and Sponsor.
- •14. Regular alcohol consumption of >14 (female subjects) or >21 (male subjects) units of
- •alcohol per week at the time of Screening (1 unit = 150 mL of wine or 360 mL of beer
- •or 45 mL of 40% alcohol).
- •15. Failure to satisfy the Principal Investigator of fitness to participate for any other
- •16. Female subjects who are pregnant, trying to become pregnant, or lactating.
- •17. Subjects who have a history of relevant drug hypersensitivity or hypersensitivity to
- •the active substance or to any of the excipients.
- •18. Inability to undergo venipuncture and/or tolerate venous access.
- •19. Subjects who do not agree to use medically acceptable methods of contraception (
研究者
相似试验
招募中
1 期
A Phase 1 Single Dose Study to Assess the Pharmacokinetics and Safety of the Biosimilar Ustekinumab Healthy VolunteersInflammatory and Immune System - Autoimmune diseasesSkin - Other skin conditionsPlaque PsoriasisACTRN12619001473156euClone Proprietary Limited210
招募中
3 期
Evaluation of efficacy and safety of SpikoGen® vaccine on adults to prevent COVID-19 diseaseIRCT20150303021315N24CinnaGen Company16,876
招募中
3 期
Evaluating the efficacy and safety of Ocrelizumab (CinnaGen, Iran) in comparison to Ocrevus® (Roche, Switzerland) in patients with relapsing multiple sclerosisRelapsing Multiple Sclerosis (RMS).Multiple sclerosis (of):NOSbrain stemcorddisseminatedgeneralizedIRCT20150303021315N13CinnaGen company170
进行中（未招募）
1 期
Clinical Trial for Comparison of RPH-001 to Avastin®on-Small Cell Lung CancerMedDRA version: 20.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-001634-26-Outside-EU/EEATRPHARM60
进行中（未招募）
不适用
Efficacy and Safety study comparing PRAVAFENIX (combination of fenofibrate and pravastatin) versus Atoravastatin in high coronary heart disease risk patients with mixed dyslipidaemiamixed dyslipidaemiaMedDRA version: 16.0Level: PTClassification code 10058108Term: DyslipidaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 16.0Level: PTClassification code 10070901Term: Diabetic dyslipidaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 16.0Level: PTClassification code 10007649Term: Cardiovascular disorderSystem Organ Class: 10007541 - Cardiac disordersEUCTR2012-000575-17-BGaboratoires SMB S.A.430