KCT0012305招募中1 期
A Phase 1, Randomized, Double-Blind, Two-Arm, Parallel Group, Single-Dose Study to Compare Pharmacokinetics and Safety of CT-P45 PFS and EU-approved Entyvio PFS in Healthy Participants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Celltrion
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18(Year) 至 55(Year)（—）
- 性别
- All
入选标准
- •Healthy male and female participants between the ages of 18 and 55 years (global standard; for Korea, 19-55 years of age will be included due to different age cut-off for minors), both inclusive
- •Participant with BMI between 18.0 and 28.0 kg/m2 and a total body weight between 50.0 and 90.0 kg, both inclusive, when rounded to the nearest tenth.
排除标准
- •Participant who has signs or symptoms of progressive multifocal leukoencephalopathy (PML) and in whom PML cannot be ruled out during Screening period or Day -
- •Participant who has a current or history of any of the following infections:
- •Known infection with hepatitis B or hepatitis C (active or carrier state), any identified congenital or acquired immunodeficiency (e.g., common variable immunodeficiency, human immunodeficiency virus, organ transplantation) or syphilis etc.
- •Participant who has a tuberculosis (TB) history and/or condition:
- •Current diagnosis of active TB or latent TB (defined as a positive result for interferon-? release assay [IGRA] with chest x-ray negative for a lesion, and without any sign or symptom of TB) etc.
- •Participant who has received or has a plan to receive any of following prohibited medications or treatments:
- •Participant who used prescription or over-the-counter (OTC) drugs, dietary supplements, or herbal remedies that could affect the outcome of the study within 14 days (or 5 half-lives, whichever is longer) prior to the administration of the study drug (Day 1) etc.
- •Participant who has undergone treatment with an investigational drug or treatment with an investigational drug for another clinical trial for healthy participant or bioequivalence test within 6 months or 5 half-lives (whichever is longer) prior to the administration of the study drug (Day 1) or plans to do so during the study. A longer time period will apply if required by the local regulatory requirements.
- •In the opinion of the investigator, the participant is not eligible for the study participation for any reason (including clinical laboratory results); shows evidence of a condition (e.g., psychological or emotional problem, any disorder or resultant therapy) that is likely to invalidate an informed consent or limit the ability of the participant to comply with the protocol requirements; or is unable to understand the protocol requirements, instructions, study-related restrictions, or the nature, scope, and possible consequences of the clinical study; or is unable to give written informed consent or to comply fully with the protocol.
- •In addition, only participants who meet all inclusion criteria and do not meet any exclusion criteria specified in the clinical trial protocol are eligible to participate in the study.
研究者
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