NCT04198636Unknown1 期
A Randomized, Double-blind, Single-dose, Parallel-group Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of LY01011 and Xgeva® in Healthy Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 168
- 主要终点
- AUC0-t
研究概览
简要总结
A randomized, double-blind, single-dose, parallel-group study to compare the pharmacokinetics, pharmacodynamics, safety and immunogenicity of LY01011 and Xgeva® in healthy adults
详细描述
This is a phase I, randomized, double-blind, single-dose, parallel-group clinical trial .
The primary objective is to assess the pharmacokinetic similarity of single and subcutaneous injections of LY01011 or Xgeva® in healthy volunteers.
The secondary objective are to compare the safety, tolerability, immunogenicity and pharmacodynamics of single and subcutaneous injections of LY01011 or Xgeva® in healthy volunteers.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sign the informed consent form and fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the test plan requirements
- •During the study period, the subjects and partners agreed to use reliable contraceptive measures
- •Aged ≥18 years or ≤50 years, male or female (including the boundary value)
- •Male body weight≥50kg，female body weight≥45kg，and 18.0≤BMI≤28.0 kg/m2
- •Clinical laboratory examination, chest X-ray, abdominal B-ultrasound, electrocardiogram, physical examination, vital signs and various examinations are normal or abnormal without clinical significance at screening
排除标准
- •Subjects are suffering from or have had osteomyelitis or osteonecrosis of the Jaw, or plan to have invasive dental or maxillofacial surgery during the study, or dental or oral surgery wounds unhealed
- •Have fractures in past six months
- •The medicines that may affect bone turnover are used before screening or planned to use in the study period , including but not limited : Denosumab, bisphosphonates or fluorides were used in past 12 months; Contraceptives with hormone were used in past 6 months，Hormone replacement therapy（tibolone、hormone、selective estrogen receptor modulators）Aromatase inhibitors, calcitonin, strontium salt, parathyroid hormone (or derivative), vitamin D supplement，Anabolic steroids, systemic glucocorticoids, calcitriol or analogues, diuretics, anticonvulsant drugs；Inhalation or local use of glucocorticoids within 2 weeks
- •Hypocalcemia or hypercalcemia，or serum calcium calibrated by serum albumin was not within the normal range
- •Subjects with allergic constitution (allergic to more than two drugs or food) or known to be allergic to the ingredients of the investigational product
- •Donated whole blood, blood component, or massive hemorrhage （>450ml）three months before screening
- •Use of any vaccines in 4 weeks of initiation of study therapy
- •Use Rx or OTC drugs or nutritional health products or herbal supplements within 14 days before the screening
- •Have been playing strenuous sports in 2 weeks before screening; or other factors affecting drug absorption, distribution, metabolism, excretion
- •The average daily smoking amount is more than 5 cigarettes per day during three months before screening;
- •History of drug abuse or alcohol abuse (drank more than 14 units / week of alcohol: 1 unit =285ml beer, 25ml spirits or 100ml Wine)；
- •History of drug abuse within 5 years prior to screening, or urine drug screening test was positive；
- •other clinically significant diseases (such as neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, metabolic endocrine system, blood system, skin diseases, immune diseases, tumors, etc.)
- •Any of HBsAg, HCV-Ab, Anti-HIV, TP-Ab was positive
- •Acute disease or combination of medication from the screening to the study before the use of investigational product ,
- •Take any alcoholic product within 48 hours before using the investigational product
- •Participation in another clinical trial within 3 months prior to enrollment
- •Anticipated of partner pregnancy during the study.
- •Other conditions that the investigator thinks unsuitable in this study
研究组 & 干预措施
LY01011
Experimental
LY01011 injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once
干预措施: LY01011 (Drug)
Xgeva®
Active Comparator
Xgeva® injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once
干预措施: Xgeva 120 MG in 1.7 ML Injection (Drug)
结局指标
主要结局
AUC0-t
时间窗: 168 days
Assess the AUC0-t similarity of single and subcutaneous injections of LY01011 or Xgeva® in healthy volunteers
Cmax
时间窗: 168 days
Assess the Cmax similarity of single and subcutaneous injections of LY01011 or Xgeva® in healthy volunteers
次要结局
- AUEC0-t of CTX-1(168 days)
- Emax(168 days)
- ADA(168 days)
- AE(168 days)
- AUC0-∞(168 days)
- CL/F(168 days)
- t1/2(168 days)
- Vd/F(168 days)
- Tmax(168 days)
- TEmax(168 days)
- Nab(168 days)
- λz(168 days)
研究者
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