NCT05777109招募中1 期
A Dual-center, Randomized, Double-blinded and Parallel-controlled Study to Assess the Pharmacokinetic, Pharmacodynamics, Safety and Immunogenicity of HS-20090 Injection and Xgeva® in Healthy Adults
Jiangsu Hansoh Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2023年4月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
A Dual-center , Randomized, double-blinded and Parallel-controlled Study to Assess the Pharmacokinetic, pharmacodynamics, Safety and Immunogenicity of HS-20090 Injection and Xgeva® in Healthy Adults
详细描述
This is a phase I, dual-center, randomized, double-blind and parallel group clinical trial .
The primary objective is to assess the pharmacokinetic similarity of single subcutaneously injection of HS-20090 or Xgeva® in healthy volunteers.
The secondary objectives are to assess the Clinical safety and immunogenicity similarity of single subcutaneously injection of HS-20090 or Xgeva® in healthy volunteers. Meanwhile, observing the pharmacodynamic similarity of HS-20090 to Xgeva® preliminarily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 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;
- •Healthy males, Aged ≥18 years and ≤50 years old(including the boundary value);
- •Subjects weighing ≥ 55 kg and ≤ 75 kg (weight difference in a single center is controlled within 10 kg), with a BMI between 19.0 and 26.0 kg/m2 (BMI = weight (kg)/height2 (m2)) (including borderline values).
- •The subject agrees to use effective contraception for at least 6 months from the screening date until after study dosing, and has no plans to have children or donate sperm within 6 months;
- •Physical examination, vital signs, laboratory examination, chest X-ray, B-ultrasound and electrocardiogram are normal, or the above tests are abnormal without clinically significance and have no effect on the test as judged by the investigator;
- •ECG examination: corrected QT interval (QTcF) < 450 ms.
排除标准
- •Occurred or suffering from osteomyelitis or ONJ (OsteoNecrosis of the Jaw) previously; The dental or jaw disease that is active, requiring oral surgery; or planned for invasive dental surgery during the study; or dental or oral surgery wounds have not healed;
- •Subjects with any previous or current clinically serious diseases such as circulatory, endocrine, neurological, digestive, respiratory, genitourinary, hematological, immunological, psychiatric, and metabolic abnormalities or any other diseases that can interfere with the study results.
- •Positive screening for hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, Acquired Immune Deficiency Syndrome (AIDS) antibodies, and syphilis spirochete antibodies.
- •Abnormal blood calcium: current hypocalcemia or hypercalcemia. Serum calcium outside the normal laboratory range; (Subjects should not apply calcium supplements for at least 8 hours prior to drawing blood for serum calcium screening assays.)
- •previous use of RANKL inhibitors or osteoclastogenesis inhibitory factor.
- •The subject is participating in another clinical study, or the first dose was administered less than 3 months after the last dose of the previous clinical study (or 5 half-lives of the study drug, whichever is longer).
- •Average daily smoking ≥ 5 cigarettes in the 3 months prior to randomization.
- •Prior history of alcohol abuse (14 units of alcohol per week: 1 unit = 360 mL of beer or 45 mL of spirits at 40% alcohol or 150 mL of wine), substance abuse or drug use.
- •Positive substance abuse screening or/and alcohol breath test screening prior to study administration.
- •Subjects who have donated blood within 3 months prior to administration, or have lost more than 400 ml of blood, or are scheduled to donate blood within 6 months.
- •Subjects who have had a significant change in physical status within 6 months prior to administration, or who have been performing strenuous exercise.
- •Subjects who, in the opinion of the investigator, have any factors that make participation in this trial inadvisable.
研究组 & 干预措施
HS-20090
Experimental
Subcutaneously injection of HS-20090 (120mg/1.7mL) once on the first day
干预措施: HS-20090 (Drug)
Xgeva®
Active Comparator
Subcutaneously injection of Xgeva® (120mg/1.7mL) once on the first day
干预措施: Xgeva® (Drug)
结局指标
主要结局
Cmax
时间窗: 155days
Maximum concentration
AUC0-∞
时间窗: 155days
The area under the curve from time 0 extrapolated to infinite time
次要结局
- AUC0-t(155days)
- t1/2z(155days)
- Serum type 1 C-telopeptide(CTX1)(155days)
- TEmax(155days)
- Tmax(155days)
- Imin(155days)
- Emax(155days)
- Vz/F(155days)
- CLz/F(155days)
- Antidrug antibody(ADA):(155days)
- AUEC0-t(155days)
- Adverse events(AE)(155days)
- Neutralizing antibody(Nab)(155days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Randomized, Double-blind, Single-dose, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male SubjectsHealthy MenNCT05968508Bio-Thera Solutions300
撤回
3 期
Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia®OsteoporosisNCT06504966Xentria, Inc.440
尚未招募
1 期
A Comparative Pharmacokinetic Study to Evaluate Different Manufacturing Batches of BAT1706 InjectionHealthy MenNCT05865574Bio-Thera Solutions38
已完成
3 期
Comparative Study of BAT2506 With Simponi® in Participants With Active Psoriatic ArthritisPsoriatic ArthritisNCT05046431Bio-Thera Solutions704
终止
1 期
A Study of JHL1101 Versus MabThera® in Subjects With Severe Rheumatoid ArthritisArthritis, RheumatoidRheumatoid ArthritisNCT03161457JHL Biotech, Inc.153