NCT05817435已完成1 期
A Phase 1, Randomized, Open-label, Parallel-Group, Single-Dose, Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial + Syringe Presentation in Healthy Adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- argenx
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Primary PK parameters (Cmax)
研究概览
简要总结
This is a randomized, open-label, parallel-group, single-dose study comparing the pharmacokinetics of efgartigimod in blood following a single administration of efgartigimod PH20 SC via a prefilled syringe versus a vial + syringe in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is at least the local legal age of consent for participation in a clinical study and ≤55 years when signing the ICF
- •Is capable of providing signed informed consent, and complying with protocol requirements
- •Agrees to use contraceptive measures consistent with local regulations and the following: Women Of Child-Bearing Potential must have a negative serum hCG pregnancy test at screening and a negative urine hCG pregnancy test at baseline before receiving IMP.
- •Has a BMI between 18 and 30 kg/m2 , inclusive, and a weight between 50 and 100 kg (inclusive) at screening
排除标准
- •Has a known autoimmune disease or any medical condition that, in the investigator's judgment, would interfere with an accurate assessment of clinical symptoms or puts the participant at undue risk
- •Has a history of malignancy, unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years before the administration of IMP. Adequately-treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological findings of prostate cancer.
- •Has a clinically significant active infection that is not sufficiently resolved in the investigator's opinion.
- •Has a positive serum test at screening for active infection with any of the following: HBV indicative of an acute or chronic infection, unless associated with a negative HBsAg or negative HBV DNA test; HCV based on HCV antibody assay unless a negative RNA test is available ; HIV based on test results (regardless of therapy treatment or not).
- •Has a clinically significant disease, recent major surgery (within 3 months of screening), or intends to have surgery during the study; or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk.
- •Received a different IMP in another clinical study <12 weeks or 5 half-lives (whichever is longer) before screening.
- •Is currently participating in another interventional clinical study. Has a known hypersensitivity to IMP or its excipients.
- •Has abdominal skin condition that does not allow for absorption and assessment of local safety of the planned SC injection, as determined by the investigator.
- •Has a history of (within 12 months before screening) or current alcohol, drug, or medication abuse, as assessed by the investigator.
- •Is pregnant or lactating or intends to become pregnant during the study.
- •Previously participated in an efgartigimod clinical study and received at least 1 dose of IMP.
- •Is taking concomitant medications (except for oral contraceptives or occasional acetaminophen).
- •Has a total IgG of <4 g/L at screening.
- •Had a positive COVID-19 test result on day -1 or contact with someone with a known COVID-19 infection within 2 weeks before receiving IMP.
结局指标
主要结局
Primary PK parameters (Cmax)
时间窗: Up to 29 days
maximum observed plasma concentration
Primary PK parameters (AUC0-inf)
时间窗: Up to 29 days
area under the concentration-time curve from 0 to infinity
次要结局
- Second PK parameters (Vz/F)(up to 57 days)
- Total IgG as percent change from baseline over time(up to 57 days)
- Second PK parameters (CL/F)(up to 57 days)
- Safety parameters (number of AEs)(up to 85 days)
- Second PK parameters (AUC0-t)(up to 57 days)
- Second PK parameters (AUC0-168h)(up to 57 days)
- Total IgG as absolute change from baseline over time(up to 57 days)
- Incidence of ADA against efgartigimod PH20 SC(up to 57 days)
- Second PK parameters (Tmax)(up to 57 days)
- Second PK parameters (t1/2)(up to 57 days)
研究者
研究点 (4)
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