CTRI/2025/07/090160尚未招募1 期
Multiple dose study to compare immunogenicity and safety of BP14 (Pegfilgrastim) 6 mg/0.6 mL solution in single use prefilled syringe and US- Licensed Neulasta® (Pegfilgrastim) 6 mg/0.6 mL solution for Injection in healthy adult male subjects
CuraTeQ Biologics Private Ltd1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年7月21日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Treatment emergent ADA incidence rate between BP14 (Pegfilgrastim) and US- Licensed Neulasta® (Pegfilgrastim)
研究概览
简要总结
This is a double blind, randomized, two-cycle, two-treatment, parallel, balanced, multiple dose study to compare 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. The objective of the study is to compare and evaluate the immunogenicity 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; and to monitor the safety and tolerability of the investigational products
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).
- •Volunteers having body weight 50 kg or more and 100 kg and less.
- •Volunteer 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
- •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.
- •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.
- •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 15) 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.
- •History of any clinically significant disease or condition that, in the opinion of the principal or sub-investigator or physician, would render them unsuitable for inclusion in the study.
结局指标
主要结局
Treatment emergent ADA incidence rate between BP14 (Pegfilgrastim) and US- Licensed Neulasta® (Pegfilgrastim)
时间窗: from day 1 to day 58
次要结局
- Immunogenicity: Incidence of anti-PEG antibodies, anti-G-CSF antibodies(from day 1 to day 58)
- Safety: TEAE, TESAEs, AESIs, Injection site reactions, clinical laboratory values, vital signs, physical examinations, & ECG(throughout the study)
研究者
Dr Dhruv Patel MBBS
Cliantha Research Limited
研究点 (1)
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