A Phase 1, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Multiple Intravenous Infusions of Efgartigimod With Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Healthy Subjects

argenx1 个研究点分布在 1 个国家目标入组 54 人2020年8月18日

适应症Healthy Volunteers

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Healthy Volunteers
发起方: argenx
入组人数: 54
试验地点: 1
主要终点: Percentage reduction in total IgG levels, compared to baseline, at day 29 (week 4), 7 days after the fourth IV or SC administration of efgartigimod
状态: 已完成
最后更新: 5年前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

This study will compare the pharmacodynamics, pharmacokinetics and safety of efgartigimod as an intravenous infusion with efgartigimod as a subcutaneous injection in healthy adults.

注册库

clinicaltrials.gov

开始日期

2020年8月18日

结束日期

2021年2月11日

最后更新

5年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

argenx

责任方

Sponsor

入排标准

入选标准

•The subject is between 18 and 65 years of age, inclusive, on the day when the ICF is signed.
•The subject is either male or female of non-childbearing potential (postmenopausal \[defined by continuous amenorrhea for at least 1 year without an alternative medical cause with a follicle-stimulating hormone (FSH) of \>33.4 IU/L; in subjects on hormonal replacement therapy, a historical value pretreatment of \>33.4 IU/L will be accepted as proof of menopausal status\]) OR have a documented permanent sterilization procedure (ie, hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
•The female subject has a negative pregnancy test at day -1
•The subject has a body mass index (BMI) between 18 and 30 kg/m2, inclusively, with a weight of ≥50 kg and ≤100 kg at screening.
•The subject is able to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of research-related health information), willing and able to comply with the protocol procedures (including required study visits).
•The subject is in good physical and mental health, per the opinion of the investigator, based on medical history, physical examination, ECG, and vital sign findings; and biochemistry, hematology, virology, and urinalysis test results prior to the first IMP administration.
•The non-sterilized male subject who is sexually active with a female partner of childbearing potential must use effective contraception (failure rate of \<1% per year). Male subject practicing true sexual abstinence (when consistent with the preferred and usual life style of the participant) can be included. The sterilized male subject who has had a vasectomy with documented aspermia postprocedure can be included. In addition, no male subject will be allowed to donate sperm during the period from signing the ICF, throughout the duration of the trial, and 90 days after the last administration of the IMP.
•The condition of the skin tissue on the subject's abdomen must allow for absorption and assessment of local safety of the planned SC injection, as determined by the investigator.
•The subject agrees to discontinue and refrain from all medications (including over-the-counter and/or prescription medications), except for occasional paracetamol use (maximum dose of 2 g/day and maximum of 10 g/2 weeks), antacid use, and ibuprofen use (maximum dose of 400 mg/day and not to be coadministered with antacid), at least 2 weeks before the first IMP administration through the final follow-up visit on day
•The subject agrees to withhold from strenuous activities from at least 2 weeks before the first IMP administration through the final follow-up visit on day

排除标准

•The subject has previously participated in clinical studies with efgartigimod (ARGX-113) and was administered an IMP.
•The subject has a known hypersensitivity to 1 of the components in the IMP, or a history of severe allergic or anaphylactic reactions, in the opinion of the investigator.
•The subject tests positively at screening for any of the following conditions: a. The subject has an active hepatitis B infection (acute or chronic) at screening as determined by hepatitis B serology.
•b. The subject has serology positive for hepatitis C virus antibody (HCV Ab). c. The subject has human immunodeficiency virus (HIV) positive serology.
•Subjects with clinically significant active or chronic uncontrolled bacterial, viral, or fungal infection at screening.
•Subjects with clinical evidence of other significant serious diseases, subjects who underwent a recent major surgery, or any other reason which could confound the results of the trial or put the subject at undue risk.
•The subject has total IgG \<6 g/L at screening.
•The subject has presence or sequelae of gastrointestinal, liver, kidney, or any other condition known to potentially interfere with the absorption, distribution, metabolism, or excretion of IMP.
•The subject has a history of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥3 years before first IMP administration. Subjects with the following cancer can be included anytime:
•Adequately treated basal cell or squamous cell skin cancer

结局指标

主要结局

Percentage reduction in total IgG levels, compared to baseline, at day 29 (week 4), 7 days after the fourth IV or SC administration of efgartigimod

时间窗: After four weeks (day 29)

次要结局

Lymphocyte count(Up to 15 weeks)
Monocyte count(Up to 15 weeks)
Percentage reduction in total IgG levels at all other assessment timepoints as of week 4(Up to 15 weeks)
AUEC for percentage reduction in total IgG levels per weekly interval after each dose (week 1, week 2, week 3, and week 4), over the interval week 1 to week 4, and over the entire study period (week 1 to week 11)(Up to 11 weeks)
AUEC for percentage reduction in IgG levels for each subtype per weekly interval after each dose (week 1, week 2, week 3, and week 4), over the interval week 1 to week 4, and over the entire study period (week 1 to week 11)(Up to 11 weeks)
Vital sign measurement: heart rate(Up to 15 weeks)
Absolute values and changes from baseline in levels of IgG subtypes (IgG1, IgG2, IgG3, and IgG4) at all assessment timepoints(Up to 15 weeks)
Cmax of efgartigimod(Up to 15 weeks)
Serum levels of efgartigimod and derived PK parameters(Up to 15 weeks)
Vital sign measurement: blood pressure(Up to 15 weeks)
Percentage reduction in levels of IgG subtypes (IgG1, IgG2, IgG3, and IgG4) at all assessment timepoints(Up to 15 weeks)
Absolute values and changes from baseline in total IgG levels at all assessment timepoints(Up to 15 weeks)
Ctrough of efgartigimod(Up to 15 weeks)
Neutrophil count(Up to 15 weeks)
ECG recording of QTcF(Up to 15 weeks)
Incidence and characterization of TEAEs(Up to 15 weeks)