NCT05734482已完成1 期
Phase I Comparison of Pharmacokinetics, Safety, and Immunogenicity of CMAB015 Injection and Cosentyx in a Randomized, Double-blind, Parallel Controlled, Single-dose Study in Healthy Chinese Male Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Maximum Concentration of Secukinumab
研究概览
简要总结
This is a randomized, double-blinded, controlled Phase I study of CMAB015 administered by subcutaneous injection. This study will characterize the pharmacokinetic, safety and immunogenicity of CMAB015 versus Cosentyx（Secukinumab ） in healthy male subjects after a single dose.
详细描述
This is a randomized, double-blind, parallel-controlled, single-dose phase I clinical study in healthy Chinese male subjects. A total of 130 subjects were planned to be enrolled and randomly assigned to the test group or the control group in a 1:1 ratio. Subjects in both groups received a single upper arm subcutaneous injection of CMAB015 or Cosentyx（Secukinumab） 150 mg, respectively. Subjects in both groups were observed for 112 days after administration to evaluate similarities in pharmacokinetics, safety, and immunogenicity.
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
- Triple (Participant, Care Provider, 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
- •Healthy male volunteers, age ranged 18 to 45 years (both inclusive)；
- •Subjects with body weight of ≥50 kg and ≤ 75 kg and BMI ≥18 and <28 kg/m2 ;
- •Subjects and their partners were willing to use medically approved contraceptive methods within 6 months of study administration, partners did not plan to become pregnant, subjects did not plan to donate sperm；
- •The subjects have the ability to understand the full characteristics and objectives of the study, including the possible risks and side effects of the study; Moreover, the subjects can communicate well with researchers and complete the research according to the regulations；
- •Subjects voluntarily sign ICF prior to the study.
排除标准
- •After comprehensive examination (vital signs, physical examination, electrocardiogram, chest radiography, abdominal B-ultrasound, blood routine, urine routine, blood biochemistry, etc.), any examination item was judged abnormal by the investigator and had clinical significance;
- •Patients with serious diseases such as cardiovascular system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematopoietic system, immune system, or any of the above diseases；
- •Patients with currently active infected diseases；
- •Subjects with past or current inflammatory bowel disease;
- •History of malignant neoplasms within the last 5 years (other than completely resected basal cell or squamous cell carcinoma of the skin in situ)；
- •Any one of HBV surface antigen, HCV antibody, HIV antibody, treponema pallidum antibody positive；
- •Subjects with T-SPOT test positive；
- •Those who smoked more than 5 cigarettes per day in the 6 months before screening and did not cooperate with smoking bans during the study period；
- •Alcoholics，or participants who consumed more than 14 units of alcohol per week (1 unit = 17.7mL ethanol, i.e., 1 unit = 357mL 5% beer or 43mL 40% liquor or 147mL 12% wine) during the preceding 3 months were screened，or who have positive result in blood-test of alcohol or not willing to ban alcohol；
- •Drug abusers, or drug users in the 3 months prior to screening, or excessive daily consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250mL) in the 3 months prior to screening, or positive urine drug screening；
- •Surgery within 4 weeks prior to screening; Or plan to have surgery during the study period；
- •Use of any prescription drug, over-the-counter drug or health product within 4 weeks prior to screening, or prior use of such drug or health product within 5 half-lives, whichever is longer；
- •Those who have used any biological agent, including live vaccine, in the 3 months prior to screening, or who plan to receive live vaccine during the study period；
- •Anti-il-17 antibody active ingredient, excipients or latex allergy；
- •Those with anti-IL-17 antibody and anti-drug antibody positive；
- •Those who have been enrolled in other clinical studies or less than 3 months since the end of the most recent clinical study；
- •Those who had lost blood or donated at least 400 mL in the 3 months prior to the trial, or had lost blood or donated at least 200 mL in the 1 month prior to screening, or planned to donate blood during the trial；
- •Those who Can not tolerate venipunction, has a history of dizziness of needle and blood；
- •Those who have special dietary requirements, or can not accept uniform diet；
- •Other conditions considered inappropriate to be included in this study.
结局指标
主要结局
Maximum Concentration of Secukinumab
时间窗: up to 2688 hours
Maximum Concentration of Secukinumab After the Single Injection of CMAB015/Cosentyx
Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time
时间窗: up to 2688 hours
Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time After the Single injection of CMAB015/Cosentyx
次要结局
- Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 2688 Hours(up to 2688 hours)
- anti-drug antibodies(ADA)(up to 2688 hours)
- Time to Maximum Concentration of Secukinumab(up to 2688 hours)
- Half time(up to 2688 hours)
- Apparent Volume of Distribution(up to 2688 hours)
- Terminal phase elimination rate constant(up to 2688 hours)
- Neutralization antibodies(Nab)(up to 2688 hours)
- Clearance Rate(up to 2688 hours)
- Percentage of participants with Adverse Events(up to 2688 hours)
研究者
研究点 (1)
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