NL-OMON46383已完成不适用
A Randomized, Open-label, Parallel Group Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety and Tolerability of a Subcutaneous Formulation with an Intravenous Formulation of ARGX-113 in Healthy Male Subjects. - ARGX-113-1702 (CS0287)
argenx bvba0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male, between 18-55 years of age, inclusive, on the day of signing the Informed Consent Form (ICF).
- •2. Body mass index (BMI) between 18-30 kg/m2, inclusive with a weight of at least 50 kg and no more than 100 kg, inclusive (only for subjects receiving Treatment A, B and D) at Screening and prior to first dosing. For subjects in Treatment subset C1 a body weight between 50 and 70 kg (inclusive) and for subjects in Treatment subset C2 a body weight between 80 and 100 kg (inclusive) at Screening and prior to first dosing.
- •3. Willingness and ability to understand the purpose and risks of the study and provide signed and dated informed consent prior to any procedures and be available for all study visits.
- •4. Non-vasectomized male subjects having a female partner of childbearing potential must agree to the use of an effective method of contraception until 90 days after the last administration of study drug.
- •5. Subjects have to agree not to donate sperm until 90 days after the last administration of study drug.
- •6. Judged by the investigator to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory findings.
- •7. Agree to discontinue and refrain from intake of all medications (including over-the-counter and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements such as Ginkgo biloba or St John*s wort), except occasional paracetamol use (maximum dose of 2 g/day and maximum of 10 g/2 weeks), at least 2 weeks prior to the first study drug administration. In addition, subjects must agree to the prohibitions and restrictions for this study.
- •8. Subject is a non-smoker, and not using any nicotine-containing products. A non-smoker is defined as an individual who has abstained from smoking for at least 1 year prior to Screening.
- •9. Negative urine drug screen (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, and tricyclic antidepressants) at Screening and Day -1.
- •10. Negative alcohol breath test at Screening and Day-1.
- •11. Oral body temperature < 38.0°C at Screening and prior to dosing on Day 1.
排除标准
- •1. Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization.
- •2. Active infection; a recent serious infection (i.e., requiring injectable antimicrobial therapy or hospitalization) within the 8 weeks prior to screening.
- •History or active infection with viral infection with human immunodeficiency virus (seropositivity to HIV-1 or -2 antibodies).
- •Active or chronic viral infection with hepatitis B virus (HBV) serologically defined as: HBsAg positive or (Anti-HBs negative and anti-HBc positive.
- •Active infection with hepatitis C virus (HCV) or known seropositivity.
- •Subjects must have a negative TB Quantiferon test at screening.
- •Subjects with an undetermined Quantiferon TB result will be allowed one retest, if not negative on retesting, the subject will be excluded
- •3. Subjects with known clinically relevant immunological disorders.
- •4. History of severe allergic or anaphylactic reactions.
- •5. Known history or any symptom of clinically significant illness in the 6 months before the first study drug administration.
- •6. Presence or having sequelae of gastrointestinal, liver, kidney or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- •7. History of malignancy within the past 5 years (except for basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
- •8. Clinically relevant abnormalities detected on ECG regarding either rhythm or conduction (e.g., QTcF > 450 ms [millisecond], or a known long QT syndrome). A first degree heart block or sinus arrhythmia will not be considered as a significant abnormality.
- •9. Clinically relevant abnormalities detected on vital signs prior to first dosing.
- •10. Significant blood loss (including blood donation [> 500 mL]), or had a transfusion of any blood product within 12 weeks prior to the initial study drug administration or plan one within 4 weeks after the end of the study.
- •11. Treatment with any drug known to have a well-defined potential for toxicity to a major organ in the last 3 months preceding the initial study drug administration.
- •12. The subject has a history of consuming more than 21 units of alcoholic beverages per week or has a history of alcoholism or drug/chemical/substance abuse within past 2 years prior to screening (Note: one unit = 330 mL of beer, 110 mL of wine or 28 mL of spirits).
- •13. Consumption of a large quantity of coffee, tea (> 6 cups per day) or equivalent.
- •14. Concurrent participation or participation within 90 days prior to the initial study drug administration in a drug/device or biologic investigational research study.
- •15. Administration of a vaccine within 60 days prior to initial study drug administration.
- •16. Administration of any systemic immunosuppressant agent within 6 months prior to initial study drug administration.
- •17. Administration of any systemic steroid within 2 months prior to initial study drug administration.
- •18. Administration of an injectable drug within 30 days prior to the initial study drug administration.
- •19. Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff or relative thereof who is directly involved in the conduct of the study.
- •20. Any condition or circumstances that in the opinion of the investigator may make
研究者
相似试验
尚未招募
2 期
Study to Assess the Efficacy and Safety of BP08 (Tocilizumab) versus Actemra�®/RoActemra�® plus Standard of Care in Severe COVID-19 patientsCTRI/2021/09/036973CURATEQ BIOLOGICS PRIVATE LIMITED India
进行中（未招募）
1 期
Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients with Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia)DyslipidemiaMedDRA version: 18.1 Level: PT Classification code 10058108 Term: Dyslipidaemia System Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2015-001934-19-GBSanofi-Aventis Groupe413
进行中（未招募）
1 期
Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients with Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia)DyslipidemiaEUCTR2015-001934-19-DESanofi-Aventis Groupe420
进行中（未招募）
1 期
Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients with Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia)DyslipidemiaMedDRA version: 20.0Level: PTClassification code 10058108Term: DyslipidaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2015-001934-19-ITSANOFI-AVENTIS GROUPE413
进行中（未招募）
1 期
Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients with Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia)MedDRA version: 18.1Level: PTClassification code 10058108Term: DyslipidaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersDyslipidemiaEUCTR2015-001934-19-FISanofi-Aventis Groupe420