A Comparative, Crossover, Pharmacokinetic, Pharmacodynamic and Safety Study of Three Forms of PEG-G-CSF in Normal Healthy Volunteers
试验速览
- 阶段
- 1 期
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
This is a comparative pharmacokinetic, pharmacodynamic and safety study in healthy volunteers with three forms of pegylated granulocyte colony stimulating factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects aged 18 to 55 years
- •A standardized body mass index
- •General good health as determined by the Investigator
- •Normal organ function as per the Investigator's judgement
- •Must be non-smokers, or ex-smokers who have not smoked within the previous 6 months from the screening visit
- •Female subjects must:
- •Not be lactating; not be pregnant
- •Agree to use an acceptable contraceptive method or be of non-childbearing potential
- •Male subjects must refrain from donating sperm or fathering a child during the study and until 3 months after the last study drug
排除标准
- •Known hypersensitivity to Escherichia coli derived proteins, pegfilgrastim, filgrastim or any other related component
- •Presence of antibodies to polyethylene glycol at screening
- •Positive result for cotinine (>500 ng/mL) or drugs of abuse at screening or on admission
- •Prior history of or current alcohol abuse or excessive intake of alcohol as judged by the Investigator
- •Donation of blood (≥500 mL) or plasma within the previous 3 months
- •History of unexplained syncopal episodes;
- •Any disorder that, in the Investigator's opinion, may interfere with study compliance
- •History of any cancer
- •History of pulmonary infiltrate or pneumonia within the previous 6 months from screening visit
- •Hereditary fructose and/or sorbitol intolerance
- •Absolute neutrophil count below 1500/mm3 or above 12000/mm3 at screening
- •Positive test for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) 1 or 2
- •Any abnormality in 12-lead ECG that in the Investigator's opinion is clinically significant and/or suggestive of underlying cardiac abnormalities
- •A clinical diagnosis of hypertension, significant hypercholesterolemia as judged by the Investigator, or thyroid abnormalities
- •Family history of acute myeloid leukemia or subjects with splenomegaly at baseline, or with sickle cell disease
- •Any prescribed or over the counter medications including analgesics, herbal remedies, vitamin therapy must not be used from 7 days prior to the first administration of study drugs
研究组 & 干预措施
Treatment Sequence III (A, DRL, B)
Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form A, DRL_PG, Pegfilgrastim Form B. Each drug is administered as a single, 6 mg, subcutaneous injection.
干预措施: DRL_PG (Biological)
Treatment Sequence I (DRL, A, B)
Patients will receive study drugs in the following cross-over sequence: DRL_PG, Pegfilgrastim Form A, Pegfilgrastim Form B. Each drug is administered as a single, 6 mg, subcutaneous injection.
干预措施: Pegfilgrastim Form A (Biological)
Treatment Sequence I (DRL, A, B)
Patients will receive study drugs in the following cross-over sequence: DRL_PG, Pegfilgrastim Form A, Pegfilgrastim Form B. Each drug is administered as a single, 6 mg, subcutaneous injection.
干预措施: Pegfilgrastim Form B (Biological)
Treatment Sequence II (DRL, B, A)
Patients will receive study drugs in the following cross-over sequence: DRL_PG, Pegfilgrastim Form B, Pegfilgrastim Form A. Each drug is administered as a single, 6 mg, subcutaneous injection.
干预措施: Pegfilgrastim Form A (Biological)
Treatment Sequence II (DRL, B, A)
Patients will receive study drugs in the following cross-over sequence: DRL_PG, Pegfilgrastim Form B, Pegfilgrastim Form A. Each drug is administered as a single, 6 mg, subcutaneous injection.
干预措施: Pegfilgrastim Form B (Biological)
Treatment Sequence III (A, DRL, B)
Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form A, DRL_PG, Pegfilgrastim Form B. Each drug is administered as a single, 6 mg, subcutaneous injection.
干预措施: Pegfilgrastim Form A (Biological)
Treatment Sequence III (A, DRL, B)
Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form A, DRL_PG, Pegfilgrastim Form B. Each drug is administered as a single, 6 mg, subcutaneous injection.
干预措施: Pegfilgrastim Form B (Biological)
Treatment Sequence IV (A, B, DRL)
Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form A, Pegfilgrastim Form B, DRL_PG. Each drug is administered as a single, 6 mg, subcutaneous injection.
干预措施: Pegfilgrastim Form A (Biological)
Treatment Sequence IV (A, B, DRL)
Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form A, Pegfilgrastim Form B, DRL_PG. Each drug is administered as a single, 6 mg, subcutaneous injection.
干预措施: Pegfilgrastim Form B (Biological)
Treatment Sequence V (B, A, DRL)
Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form B, Pegfilgrastim Form A, DRL_PG. Each drug is administered as a single, 6 mg, subcutaneous injection.
干预措施: Pegfilgrastim Form A (Biological)
Treatment Sequence V (B, A, DRL)
Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form B, Pegfilgrastim Form A, DRL_PG. Each drug is administered as a single, 6 mg, subcutaneous injection.
干预措施: Pegfilgrastim Form B (Biological)
Treatment Sequence VI (B, DRL, A)
Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form B, DRL_PG, Pegfilgrastim Form A. Each drug is administered as a single, 6 mg, subcutaneous injection.
干预措施: Pegfilgrastim Form A (Biological)
Treatment Sequence VI (B, DRL, A)
Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form B, DRL_PG, Pegfilgrastim Form A. Each drug is administered as a single, 6 mg, subcutaneous injection.
干预措施: DRL_PG (Biological)
Treatment Sequence VI (B, DRL, A)
Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form B, DRL_PG, Pegfilgrastim Form A. Each drug is administered as a single, 6 mg, subcutaneous injection.
干预措施: Pegfilgrastim Form B (Biological)
Treatment Sequence V (B, A, DRL)
Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form B, Pegfilgrastim Form A, DRL_PG. Each drug is administered as a single, 6 mg, subcutaneous injection.
干预措施: DRL_PG (Biological)
Treatment Sequence IV (A, B, DRL)
Patients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form A, Pegfilgrastim Form B, DRL_PG. Each drug is administered as a single, 6 mg, subcutaneous injection.
干预措施: DRL_PG (Biological)
Treatment Sequence II (DRL, B, A)
Patients will receive study drugs in the following cross-over sequence: DRL_PG, Pegfilgrastim Form B, Pegfilgrastim Form A. Each drug is administered as a single, 6 mg, subcutaneous injection.
干预措施: DRL_PG (Biological)
Treatment Sequence I (DRL, A, B)
Patients will receive study drugs in the following cross-over sequence: DRL_PG, Pegfilgrastim Form A, Pegfilgrastim Form B. Each drug is administered as a single, 6 mg, subcutaneous injection.
干预措施: DRL_PG (Biological)
结局指标
主要结局
Cmax
时间窗: 105 days
Maximum plasma concentration
AUEC(0-t)
时间窗: 105 days
Area under the effect time curve from time zero (predose) to last measured time
AUC(0-t)
时间窗: 105 days
Area under concentration-time curve from time 0 to the time of the last quantifiable concentration
AUC(0-inf)
时间窗: 105 days
Area under concentration-time curve extrapolated from time 0 to infinity
Emax
时间窗: 105 days
Maximum observed effect
次要结局
未报告次要终点