NCT05323708已完成1 期
A Randomized, Double-blind, Two-arm, Single-dose, Parallel-Group Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Volunteers
Biocon Biologics UK Ltd2 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2022年3月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- AUCinf (Area Under the Concentration infinity)
研究概览
简要总结
This study is to compare the Pharmacokinetics, Pharmacodynamics, safety, and tolerability of Bmab 1000 and Prolia® in normal healthy volunteers.
详细描述
This study will consist of 2 study periods: Screening period (4 weeks) and Treatment period (Dosing and follow-up).
In this double-blind, 2-arm study, the eligible subjects will be randomized in a 1:1 ratio to receive either Bmab 1000 or Prolia® on Day 1. The interventions (Bmab 1000 or Prolia®) will be administered subcutaneously. End-of-study visit will be at Week 36 post randomization.
The total duration of study participation for a subject will be up to 40 weeks.
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)
盲法说明
Double-blind (Patient, Investigator)
入排标准
- 年龄范围
- 28 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gender: Male or Female
- •Age: Male subjects: 28-55 years, inclusive at screening; Female subjects: 28-45 years, inclusive at screening.
- •Weight: For non-Japanese subjects 60.0-95.0 kg, inclusive at screening. For Japanese subjects 55.0-95.0 kg, inclusive at screening.
- •Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at screening.
- •Vital signs showing no clinically relevant deviations according to the Investigator's judgment or their designee's. In the case of subjects > 45 year-old, if a value of SBP above 145 mmHg is confirmed on rechecking the BP after a period of rest, this subject will not be included in the study.
- •12-lead ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the Investigator or their designee.
排除标准
- •Evidence of clinically relevant pathology: Like have a history of and/or current clinically significant gastrointestinal, renal, hepatic, cardiovascular, haematological, pulmonary, neurologic, metabolic, psychiatric disorder, drug or alcohol abuse, or allergic disease excluding mild asymptomatic seasonal allergies. Have a history of malignancy (including lymphoma, leukaemia, and skin cancer).
- •Unable to follow protocol instructions or not likely to complete the study in the opinion of the Investigator or their designee.
- •History of relevant drug and/or food allergies (including hypersensitivity to any recombinant protein drug or any of the constituents of denosumab, or latex allergy or hereditary problems of fructose intolerance).
- •Known history of previous exposure to denosumab.
- •Have previously been exposed to a monoclonal antibody or fusion protein (other than denosumab) within 270 days (or 5 half-lives whichever is the longest) prior to randomization and/or there is confirmed evidence or clinical suspicion of immunogenicity from previous exposure to a monoclonal antibody or fusion protein.
- •Prior diagnosis of bone disease, or any condition that will affect bone metabolism such as, but not limited to: osteoporosis, osteogenesis imperfect, hyperparathyroidism, hyperthyroidism, hypothyroidism, osteomalacia, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, current flare-up of osteoarthritis and/or gout, active malignancy, renal disease (defined as glomerular filtration rate < 60 mL/min), Paget's disease of the bone, recent bone fracture (within 6 months), malabsorption syndrome.
- •Any use of the following bone modifying medications, with no limitation on time since administration: e.g.intravenous bisphosphonates, strontium, fluoride (if administered in treatment of osteoporosis),romosozumab, teriparatide or any parathyroid hormone analogs, calcitonin, and cinacalcet.
结局指标
主要结局
AUCinf (Area Under the Concentration infinity)
时间窗: 0 to 36 week
Area under the concentration-time curve from time zero to infinity
AUClast (Area Under the Concentration last)
时间窗: 0 to 36 week
Area under the concentration-time curve from time zero to last quantifiable concentration
Cmax
时间窗: 0 to 36 week
Maximum serum concentration
次要结局
- Vd/F(0 to 36 week)
- Cl/F(0 to 36 week)
- AUEC of sCTX(0 to 36 week)
- Incidence of ADAs (Anti-Drug Antibodies)(0 to 36 week)
- Tmax(0 to 36 week)
- t1/2(0 to 36 week)
- Emax of sCTX(0 to 36 week)
- Kel(0 to 36 week)
- Incidence of TEAEs(Treatment Emergent Adverse Events)(0 to 36 week)
- Incidence of SAEs(Serious Adverse Events)(0 to 36 week)
- Titer of ADAs(0 to 36 week)
研究者
研究点 (2)
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