NL-OMON52853已完成不适用
A First-in-Human, Randomized, Double-Blinded, Placebo-Controlled Trial in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Intravenous Dose Levels of ARGX-117 and Subcutaneous Dose Levels of ARGX-117 Co-Mixed with Recombinant Human Hyaluronidase PH20 - SAD and MAD study with IV and SC doses of ARGX-117
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- argenx BV
- 入组人数
- 112
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
- •1. The subject is between 18-65 years of age, inclusive, at the time the
- •informed consent form is signed.
- •2. The subject is either male or female of non-childbearing potential. Females
- •in the following categories are considered a woman of non-childbearing
- •a. Postmenopausal female: A postmenopausal state is defined as continuous
- •amenorrhea for at least 1 year without an alternative medical cause and a
- •follicle-stimulating hormone (FSH) measurement of >40 IU/L. A historical
- •pretreatment FSH measurement of >40 IU/L is accepted as proof of a
- •postmenopausal state for subjects on hormone replacement therapy.
- •b. Surgically sterile female: women who have had a documented permanent
- •sterilization procedure (ie, hysterectomy, bilateral salpingectomy, or
- •bilateral oophorectomy).
- •3. Female subjects must have a negative serum pregnancy test on day -1 before
- •IMP can be administered.
- •4. The subject has a body mass index (BMI) within the range 18-30 kg/m2 and
- •body weight 50-100 kg (inclusive) before IMP administration.
- •5. The subject is able to understand the requirements of the trial and provide
- •written informed consent (including consent for the use and disclosure of
- •research-related health information) and is willing and able to comply with the
- •trial protocol procedures (including the required trial visits).
- •Further criteria apply.
排除标准
- •1. The subject has a known hypersensitivity to one of the components of the
- •IMP, or, in the opinion of the investigator, a history of a significant
- •allergic reaction to any drug.
- •2. The subject has previously participated in a clinical trial with
- •efgartigimod and was administered an IMP.
- •3. The subject has a positive serum test at screening for an active viral
- •infection with any of the following conditions:
- •a. Hepatitis B virus (HBV) that is indicative of an acute or chronic infection
- •b. Hepatitis C virus (HCV) based on HCV antibody assay
- •c. Human immunodeficiency virus (HIV)
- •4. The subject tests positively at screening for SLE as determined by the SLE
- •test panel.
- •5. The subject has a known family history of SLE.
- •Further criteria apply.
研究者
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