NCT03917628已完成1 期
Pharmacokinetics and Safety of SCT630 in Healthy Subjects: a Randomized, Double-blind, Single Dose Clinical Phase I Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
Investigate the pharmacokinetics, safety and tolerability of SCT630 and to establish pharmacokinetic similarity of SCT630 to adalimumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subjects aged 18 to 45 years
- •Body mass index (BMI) between 19 and 26 kg/m2
- •Normal or clinically acceptable physical examination, clinical laboratory values, ECG, chest X-ray and vital signs at screening and baseline.
- •Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.
排除标准
- •History or evidence of a clinically significant disorder, condition, or disease that would have posed a risk to subject safety or would have interfered with the study evaluation, procedures, or study completion in the opinion of the investigator.
- •Evidence of any bacterial, viral, parasitic, systemic fungal infections, or infections due to other opportunistic pathogens within the 30 days prior to investigational product administration.
- •History of tuberculosis,positive test for Interferon-gamma-release assay,or suffering from active tuberculosis or latent tuberculosis infection.
- •History of malignancy of any type, other than surgically excised nonmelanomatous skin cancers, within 5 years prior to investigational product administration.
- •Positive test for HIV antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies at screening.
- •History of relevant allergy/hypersensitivity (including allergy to drug or its excipients).
- •Quantification of Hepatitis B virus DNA is greater than the upper limit of normal value.
- •Received biologics or live vaccines ≤3 months prior to investigational product administration.
- •Intake of an investigational drug in another trial within three months prior to investigational product administration.
研究组 & 干预措施
SCT630
Experimental
Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing SCT630
干预措施: SCT630 (Drug)
adalimumab-EU source
Active Comparator
Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing adalimumab-EU source
干预措施: adalimumab-EU source (Drug)
结局指标
主要结局
Cmax
时间窗: at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing.
Maximum Concentration (Cmax) of SCT630 and EU-licensed Humira
AUC0-tz
时间窗: at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing.
Area Under the Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC0-tz) of SCT630 and EU-licensed Humira
次要结局
- AUC 0-∞(at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing.)
- λz(Day 1 through Day 71)
- Vd(Day 1 through Day 71)
- Tmax(at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing.)
- CL(Day 1 through Day 71)
- Number (Proportion) of Subjects With Drug Related Adverse Events(Day 1 through Day 71)
- t1/2(at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing.)
- Positive rate of ADA and NAb(Day 1 through Day 71)
研究者
研究点 (1)
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