Single dose study to compare pharmacokinetic, pharmacodynamic, immunogenicity and safety of BP14 (Pegfilgrastim) 6 mg/0.6 mL solution in single use pre-filled syringe and US-Licensed Neulasta (Pegfilgrastim) 6 mg/0.6 mL solution for Injection in healthy adult male subjects
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Pharmacokinetics Parameters : Cmax, AUCt, AUCi, Tmax, Kel, AUC_%Extrap_obs and tHalf
研究概览
简要总结
This will be a phase 1, double blind, randomized, two-period, two treatment, two-sequence, crossover, balanced, single dose study to compare pharmacokinetic, pharmacodynamic, immunogenicity and safety in healthy adult male subjects. The objective of the study is to compare and evaluate the pharmacokinetic, pharmacodynamic, immunogenicity and safety of BP14 (Pegfilgrastim) 6 mg/0.6 mL solution in single use pre-filled syringe with that of US- Licensed Neulasta® (Pegfilgrastim) 6 mg/0.6 mL solution for Injection administered through subcutaneous route in healthy, adult, male subjects.
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)（—）
入选标准
- •Volunteers must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified.
- •Age: 18 to 55 years old, both inclusive.
- •Gender: Male.
- •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).
- •Volunteers having body weight 50 kg or more and 100 kg and less 5) Volunteers is considered to be in good health, as determined by: a) The absence of clinically significant illness or surgery within 4 weeks prior to dosing.
- •b) The absence of a clinically significant history of disease.
- •c) The absence of a clinically significant history of skin disorders, including psoriasis 6) Able to communicate effectively with study personnel.
- •Willing to provide written informed consent to participate in the study.
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 Pegfilgrastim, filgrastim, Escherichia coli (E.
- •coli)- derived proteins or other related drugs, or any of its formulation ingredients.
- •History of allergic reactions or hypersensitivity to acetate/acetic acid, polysorbate 20, or sorbitol.
- •Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG, chest X-ray recording and ultrasonography abdomen].
- •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 the first dose of study medication.
- •Use of any depot injection or implant of any drug within 3 months prior to the first dose of study medication.
- •Use of CYP enzyme inhibitors or inducers within 30 days prior to the first dose of study medication 8) History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
- •Smokers who smoke 10 or more cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period.
- •History of difficulty with donating blood or difficulty in accessibility of veins.
- •A positive hepatitis screen (includes subtypes B & C).
- •A positive test result for HIV antibody.
- •Volunteers who have received a known investigational drug within seven elimination half-life of the administered drug prior to the first dose of study medication.
- •Intolerance to venipuncture 14) Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the volunteer’s participation in this study.
- •Institutionalized volunteers.
- •Use of any prescribed medications within 14 days prior to the first dose of study medication.
- •Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
- •Use of grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication.
- •Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeine containing sodas, colas, etc.), cigarettes and tobacco containing products, recreational drugs, alcohol or other alcohol containing products within 48 hours prior to the first dose of study medication.
- •Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication.
- •Volunteer with history of cancer.
- •Acute viral or bacterial infection within 1 month prior to initial dosing only if considered clinically significant in the opinion of the principal or sub-investigator.
结局指标
主要结局
Pharmacokinetics Parameters : Cmax, AUCt, AUCi, Tmax, Kel, AUC_%Extrap_obs and tHalf
时间窗: Pharmacokinetic Timepoints | 19 timepoints from day 1 to day 20 | Pharmacodynamic Timepoints | 19 timepoints from day 1 to day 20 | Immunogenicity Timepoints: | 03 timepoints from day 1 to day 20 | Safety endpoints: | Throughout the study
Pharmacodynamic Parameters : Amax, AUEC(0-t)
时间窗: Pharmacokinetic Timepoints | 19 timepoints from day 1 to day 20 | Pharmacodynamic Timepoints | 19 timepoints from day 1 to day 20 | Immunogenicity Timepoints: | 03 timepoints from day 1 to day 20 | Safety endpoints: | Throughout the study
Immunogenicity Parameters : Anti-Drug Antibody (ADA)
时间窗: Pharmacokinetic Timepoints | 19 timepoints from day 1 to day 20 | Pharmacodynamic Timepoints | 19 timepoints from day 1 to day 20 | Immunogenicity Timepoints: | 03 timepoints from day 1 to day 20 | Safety endpoints: | Throughout the study
次要结局
- To monitor the safety & tolerability of the investigational products(Safety : Safety events review & analysis)
研究者
Dr Dhruv Patel
Cliantha Research Limited,