A Single Center, Single-Dose, Double-Blind, Randomized, Two-Period, Crossover Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-PEG, and US-Neulasta®, and to Evaluate Safety in Healthy Adult Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- AUC0-t
研究概览
简要总结
A Single Center, Single-Dose, Double-Blind, Randomized, Two-Period, Crossover Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-PEG, and US-Neulasta®, and to Evaluate Safety in Healthy Adult Male Volunteers
详细描述
Participants will be admitted to the clinical research unit (CRU) on Day -1. Eligible participants will be randomized (1:1) on Day -1 to 1 of 2 treatment sequences. Participants will then receive a single 6 mg SC dose during Treatment Period 1 of either NKF-PEG, or US-Neulasta, according to the randomization schedule. Participants will be discharged from the CRU on Day 13 and will return to the CRU on Day 16 for PK/PD analysis and for safety assessments.
Following the washout period of 6 weeks, the same schedule will be followed for Treatment Period 2, where participants will receive a single 6 mg SC dose of the final product according to their treatment sequence, then discharge from the CRU on Day 13 of Treatment Period 2 and will return for ambulatory visits on Day 16 of Treatment Period 2 and Safety Visit (Day 84).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Clinical Research Coordinator
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Participant must be 18 to 55 years of age, at the time of signing the informed consent.
- •Body weight ≥ 50 kg and body mass index (BMI) within the range 18.5-30.0 kg/m2 (inclusive).
- •Male assigned at birth, inclusive of all gender identities. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •a. Male participants:
- •Participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study intervention:
- •Refrain from donating sperm
- •PLUS, either:
- •Be abstinent from intercourse where pregnancy can occur (abstinent on a long term and persistent basis) and agree to remain abstinent.
- •Must agree to use contraception as detailed below:
- •Agree to use birth control (2 highly effective methods of contraception including 1 barrier method) when having sexual intercourse with a partner able to give birth who is not currently pregnant.
- •Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Willingness to follow protocol defined restrictions and Investigator/staff instructions and protocol procedures.
排除标准
- •Sensitivity to any of the study interventions, or components thereof including E. coli derived proteins, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
- •With any clinically significant abnormalities identified during screening in physical examination, vital signs, laboratory tests, or 12-lead ECG.
- •History or presence of cardiovascular, respiratory, psychiatric, metabolic, hepatic, renal, gastrointestinal, endocrinological, hematological, oncological, or neurological disorders determined to be clinically significant by the Investigator.
- •Evidence of active infection, including chronic or localized infections, by history, physical examination findings, or laboratory data, as determined by the Investigator within 1 week prior to Day
- •Rash, scarring, dermatological condition, or tattoo in the area of the injection site that could interfere with the injection or injection site assessment.
- •History or presence of any condition that in the opinion of the Investigator would constitute a risk when taking the study intervention or interfere with the interpretation of data.
- •A history of alcohol abuse within 3 months prior to screening (alcohol consumption of more than 14 units per week: 1 unit of alcohol = 285 mL beer, or 25 mL spirits, or 100 mL wine).
结局指标
主要结局
AUC0-t
时间窗: 0 to 360 hours
Area under the concentration-time curve from time 0 to the last quantifiable concentration
Cmax
时间窗: 0 to 360 hours
Maximum observed serum concentration
AUEC0- t for ANC
时间窗: 0 to 360 hours
Area under the effect curve for ANC
Emax of ANC
时间窗: 0 to 360 hours
Maximum response (Emax) of ANC
次要结局
- The proportion of participants with post dose positive neutralizing antibody result of pegfilgrastim at any time during the study(0-84 days)
- AUC0-inf(0 to 360 hours)
- Tmax(0 to 360 hours)
- T1/2(0 to 360 hours)
- Tmax of ANC(0 to 360 hours)
- Tmax of CD34+ cell count(0 to 360 hours)
- AUEC0-t of CD34+ cell count(0 to 360 hours)
- Emax of CD34+ cell count(0 to 360 hours)
- The proportion of participants with treatment-induced anti-pegfilgrastim antibodies at any time during the study(0-84 days)
- The proportion of participants with treatment-induced anti-filgrastim antibodies at any time during the study(0-84 days)
- The proportion of participants with treatment-induced anti-PEG antibodies at any time during the study(0-84 days)
- Adverse event (AE) assessments (including injection site reactions)(0-84 days)