NCT07147257已完成1 期
A Single-Center, Randomized, Single-Blind, Single-Dose, Parallel-Group Trial to Assess the Pharmacokinetic Similarity Between CHS-1420 40 mg/0.4 mL and HUMIRA® (Adalimumab) 40 mg/0.4 mL in Healthy Chinese Adult Participants Under Fasting Conditions
Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 238 人开始时间: 2025年2月12日最近更新:
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
- 238
- 试验地点
- 1
- 主要终点
- PK Endpoints
研究概览
简要总结
A Single-Center, Randomized, Single-Blind, Single-Dose, Parallel-Group Trial to Assess the Pharmacokinetic Similarity Between CHS-1420 40 mg/0.4 mL and HUMIRA® (Adalimumab) 40 mg/0.4 mL in Healthy Chinese Adult Participants under Fasting Conditions
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
- Double (Participant, Investigator)
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
- •Able to provide signed Informed Consent Form before the trial, and fully understand the trial content, process and possible adverse drug reactions (ADRs)
- •Able to complete the trial in compliance with the protocol
- •Participants (including males) willing to adopt effective contraceptive methods and with no pregnancy plan from 14 days before screening to 6 months after the last scheduled visit
- •Males and females between 18 and 55 years old, inclusive
- •At least 50 kg for participants, with a Body Mass Index(BMI)=Weight/ Height2 (kg/m2) between 19.0-26.0 kg/m2, inclusive
- •No history of chro nic or serious cardiac, hepatic, renal, digestive tract,nervous system, hematologic, respiratory, dermatological, mental and metabolic disorders, etc.
排除标准
- •With ≥ 5 cigarettes per day on average within 3 months before screening, or not able to quit smoking during the trial
- •Allergic constitution, or allergic to the drug components and its analogues; history of allergic reaction to a biological medication
- •A history of alcohol abuse (alcohol consumption of more than 14 units per week : 1 unit of alcohol = 285 mL beer, or 25 mL spirits, or 100 mL wine)
- •Blood donation or massive blood loss (> 400 mL) within 3 months before investigational products dosing; Or any blood donation plan from screening until 3 months after administration
- •History of any major surgery within the past year, or history of any surgery within the past 6 months; or any elective medical procedures, including dental procedures
- •Any history of organ transplantation
- •Medical history of tuberculosis (or suspected tuberculosis), or with a positive tuberculosis test result
- •Medical history of heart failure or other cardiac disorders which may lead to heart failure, e.g. coronary heart disease, hypertension, senile degenerative valvular disease, rheumatic valvular heart disease, dilated cardiomyopathy, acute severe myocarditis
- •Medical history of immune system disorders (e.g. systemic lupus erythematosus, multiple sclerosis, etc.), or positive results of antinuclear antibody tests
- •Medical history of recurrent or chronic infections (including transverse myelitis, optic neuritis, other demyelinating disorders, etc.), or a history of an opportunistic infection within the past year due to bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens
- •History of seizure attack
- •Medication history of TNF-α blockers e.g. Adalimumab or its analogues
- •Any medication of monoclonal antibodies within the past year before investigational products dosing
- •Any usage history of prescription medicines or OTCs (especially antibiotics), or Chinese herbal medicine or health supplementary within 30 days before investigational products dosing
- •Any vaccination within 3 months before investigational products dosing, or any plan for vaccination within 3 months after investigational products administration
- •Consumption of any special diets or food items (such as grapefruit), or strenuous exercise engagement, or other factors in the opinion of investigators affecting drug absorption, distribution, metabolism and excretion within 7 days before investigational products dosing
- •Participation in other drug clinical trials within 3 months before investigational products dosing
- •Any clinically significant abnormality findings, as judged by a clinical physican, such as physical examination, vital signs, electrocardiogram and laboratory tests, as well as Chest X-ray
- •Positive results of hepatitis B surface antigen, hepatitis C antibody, and HIV antibody or syphilis
- •Consumption of chocolate or any food/beverage containing caffeine or rich in xanthine within 48 h before investigational products dosing
- •Consumption of any products containing alcohol within 48 h before investigational products dosing, or a positive result of the alcohol breath test
- •A positive result of the drug abuse test, or a history of drug abuse in the past 5 years, or intake of any narcotic drugs within 3 months prior to the trial
- •A positive result of the pregnancy test, or in lactation during screening or the test period for female participants
- •Not tolerable on venipuncture, or a history of fainting on acupuncture and/or blood
- •Special requirements and unable to follow the unified diet
- •Unable to participate in this trial for participants' own reasons
- •Other conditions in which participants are not suitable for the trial determined by investigators
研究组 & 干预措施
CHS-1420
Experimental
干预措施: CHS-1420 (Biological)
HUMIRA®
Active Comparator
干预措施: HUMIRA® (Biological)
结局指标
主要结局
PK Endpoints
时间窗: Day1 to Day 65
The maximum serum drug concentration (Cmax)
Areas Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUC0-∞)
时间窗: 0 to 1536 hours post-dose
pre-dose (0 h) and at 2, 4, 8, 12,24,36,48,60,72,96,120,144,168,216,288,360,528,696,864,1032,1200,1368,1536h post-dose
The Maximum Serum Drug Concentration (Cmax)
时间窗: 0 to 1536 hours post-dose
pre-dose (0 h) and at 2, 4, 8, 12,24,36,48,60,72,96,120,144,168,216,288,360,528,696,864,1032,1200,1368,1536h post-dose
次要结局
- Immunogenicity Estimands(Day1 to Day 65)
- Safety Estimands(Day1 to Day 65)
- Areas Under the Serum Concentration Versus Time Curve Calculated to the Last Measurable Observation (AUC0-t)(0 to 1536 hours post-dose)
- Areas Under the Serum Concentration Versus Time Curve Calculated to 65 Days Postdose(AUC0-65days)(0 to 1536 hours post-dose)
- The Time to Maximum Serum Concentration(Tmax)(0 to 1536 hours post-dose)
- The Elimination Half-life (t1/2)(0 to 1536 hours post-dose)
- Elimination Rate Constant (Kel)(0 to 1536 hours post-dose)
- Volumeof Distribution (Vd/F)(0 to 1536 hours post-dose)
- Clearance(CL/F)(0 to 1536 hours post-dose)
研究者
研究点 (1)
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