CTRI/2024/02/063101尚未招募不适用
Single dose study to compare pharmacokinetic, pharmacodynamic and immunogenicity of Denosumab 60 mg prefilled syringe solution for injection (60 mg/mL) and Prolia® (Denosumab) 60 mg solution for injection (60 mg/mL) in pre-filled syringe in healthy adult male subjects.
Lupin Limited (Research Park)1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年4月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Comparitive pharmacokinetic and pharmacodynamic
研究概览
简要总结
Single dose study to compare pharmacokinetic, pharmacodynamic and immunogenicity of Denosumab 60 mg prefilled syringe solution for injection (60 mg/mL) and Prolia® (Denosumab) 60 mg solution for injection (60 mg/mL) in pre-filled syringe in healthy adult male subjects.
Study duration 128 days.
A double blind, randomized, single-period, two-treatment, parallel, balanced, single dose comparative pharmacodynamic, pharmacokinetic and immunogenicity study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Male
入选标准
- •BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5) Able to communicate effectively with study personnel.
- •Willing to provide written informed consent to participate in the study.
- •All volunteers must be judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication which will include: a) A physical examination (clinical examination) with no clinically significant finding.
- •b) Results within normal limits or clinically non-significant for the following tests:
- •Hematology test
- •Biochemistry test
- •Urinalysis
- •Immunological Tests
- •Additional tests Additional tests and/or examinations (apart from mentioned in protocol) may be performed, if necessary, based on principal investigator discretion.
- •All results will be assessed against the current laboratory normal ranges at the time of testing and a copy of the normal ranges used will be included in the study documentation.
排除标准
- •Volunteers must not be enrolled in the study if they meet any one of the following criteria: 1) History of allergic responses to Denosumab or other related drugs, or any of its formulation ingredients.
- •Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG, chest X-ray recording, Ankle Brachial Index test].
- •Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
- •History or presence of bronchial asthma.
- •Use of any hormone replacement therapy within 3 months prior to study medication administration.
- •Use of any depot injection or implant of any drug within 3 months prior to study medication administration.
- •Use of CYP enzyme inhibitors or inducers within 30 days prior to study medication administration (see https://drug-interactions.medicine.iu.edu/MainTable.aspx).
- •History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
- •Smokers who smoke 10 or more cigarettes/e-cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period.
- •A positive hepatitis screen (includes subtypes B & C).
- •A positive test result for HIV antibody.
结局指标
主要结局
Comparitive pharmacokinetic and pharmacodynamic
时间窗: 12 months
次要结局
- Presence of anti-drug antibodies (ADA) and the neutralizing antibodies((NAb) will be determined.)
研究者
Dr Dharit Shah
Cliantha research
研究点 (1)
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