NL-OMON53520招募中不适用
A Phase 1, Randomized, Double Blinded, Placebo Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX 119 in Healthy Participants - FIH/SAD/MAD study for ARGX-119
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- argenx BV
- 入组人数
- 116
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 64（—）
入选标准
- •Participants are eligible to be included in the study only if all of the
- •following criteria apply
- •1. Has reached the age of consent at the time of signing the informed consent
- •form but is <=65 years of age
- •2. Is capable of providing signed informed consent and understands and is
- •capable of complying with protocol requirements
- •3. Is a healthy, defined as having no clinically meaningful abnormalities
- •identified in any of the following assessments before the first IMP
- •administration on day 1: medical history, physical examination, standard
- •12-lead ECG, vital sign measurements, and clinical laboratory tests
- •4. Is either male or a female of nonchildbearing potential.
- •5. Has negative serum pregnancy tests at both screening and on day -1 (female
- •participants)
- •further criteria apply
排除标准
- •Participants will be excluded from the study if any of the following criteria
- •1. Has a known hypersensitivity to any of the components of the IMP, or has a
- •history of a significant allergic reaction to any drug that is considered
- •exclusionary by the investigator
- •2. Has been given an investigational product within 3 months or 5 half-lives
- •(whichever is longer) before their first IMP administration if known
- •3. Has a positive serum test at screening for an active infection with any of
- •the following conditions:
- •a. HBV that is indicative of an acute or chronic infection, unless associated
- •with a negative HBsAg or negative HBV DNA test
- •b. HCV based on HCV antibody assay unless a negative RNA test is available
- •c. HIV based on test results
- •4. Has a positive COVID-19 test result on day -1, if performed. COVID-19
- •testing will be
- •performed if considered necessary by the PI or required locally.
- •5. Has a history of any medical or psychiatric condition that, in the opinion
- •of the investigator, is clinically meaningful, may confound the result of the
- •study, or may pose additional risks to the participant while taking part in the
- •further criteria apply
研究者
相似试验
已完成
1 期
A Phase I, Randomised, Double-Blinded, Placebo Controlled, Safety and Pharmacokinetic Study of (Z)-Endoxifen in Healthy Female VolunteersEstrogen Receptor Positive (ER+) breast cancerCancer - BreastACTRN12619000961145Atossa Genetics AUS Pty Ltd25
已完成
1 期
A Phase I, Randomised, Double-Blinded, Placebo Controlled, Safety and Pharmacokinetic Study of (Z)-Endoxifen Tablets in Healthy Female VolunteersEstrogen Receptor Positive (ER+) Breast CancerCancer - BreastACTRN12619001623189Atossa Genetics Aus Pty Ltd12
尚未招募
1 期
A Phase 1, Randomised, Double-Blind, placebo controlled, single and multiple ascending dose study to evaluate the safety, tolerability and pharmacokinetics of KZR-616 in healthy female subjects.Chronic inflammatory conditions for example rheumatoid arthritisAutoimmune disorders for example systemic lupus erythematosusInflammatory and Immune System - Autoimmune diseasesACTRN12618002060224Clinical Netwprk Services72
已完成
Unknown
A Phase 1 study, oral VVZ2471 in healthy male volunteersKCT0008891Vivozon87
招募中
1 期
Investigation of AV411 in Healthy SubjectsHealthy subjectsOther -ACTRN12606000410550Avigen, Inc.16