NCT05917782已完成1 期
A Randomized, Open-Label, Parallel-Designed, Phase I Clinical Study to Evaluate the Pharmacokinetics Similarity of Single-Dose CBP-201 Injection With Different Dosage Forms and Strengths in Healthy Adult Chinese Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- AUC0-inf: Area under the plasma concentration-time curve from the start of administration to infinity
研究概览
简要总结
This is a single-center, randomized, open-label, single-dose, parallel-designed PK similarity study.
详细描述
A total of 324 healthy subjects are planned to be enrolled and randomized into 3 groups at a ratio of 1:1:1, with 108 subjects in each group. They will receive 2 doses of the test drug T1 (CBP-201 injection (pre-filled syringe, 150 mg/1 mL)), 1 dose of the test drug T2 (CBP-201 injection (pre-filled syringe, 300 mg/2 mL)), and 2 doses of the reference drug R (CBP-201 injection (vial, 150 mg/1 mL)), respectively.
The study consists of a screening period (Day-28 to Day-2), a baseline period (Day-1), an administration and observation period (Day1 to Day6), and a follow-up period (Day7 to Day57).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who are to read, understand, and sign the ICF.
- •Healthy adult male or female subjects aged 18-45 years (inclusive) at screening, with each sex accounting for at least one-third of the overall sample size.
- •Body mass index (BMI) is between 19 and 28 kg/m2 (inclusive). Male subjects weigh ≥ 50 kg, and female subjects weigh ≥ 45 kg.
- •Subjects with partners must agree to take medically accepted effective contraceptive measures (including physical contraception, surgery, abstinence, etc) from signing of the ICF until 90 days after administration.
- •The results of vital sign assessment, physical examination, clinical laboratory tests (hematology, urinalysis, biochemistry, coagulation) and 12-lead ECG at screening or baseline are normal or abnormal but not clinically significant.
- •Subjects who are able to communicate well with the clinical staff and complete the study according to the protocol.
排除标准
- •Subjects who have diseases or conditions with abnormal clinical manifestations, including but not limited to renal, cardiac, hematological, bronchial, pulmonary, vascular, gastrointestinal, allergic, neurological, endocrine and metabolic diseases (diabetes mellitus, thyroid disorder, and adrenal disorder), skeletal disease and immunodeficiency, cancer, and hepatitis, or cirrhosis.
- •Subjects with allergic diseases (such as allergic rhinitis, allergic asthma) at screening, a history of systemic anaphylaxis, or who may be allergic to any component of the test drugs or similar drugs as determined by the investigator.
- •Subjects who have donated blood or have had substantial loss of blood (> 400 mL) within 3 months before administration.
- •Subjects who have been vaccinated with live (attenuated) vaccines within 3 months before administration.
- •Subjects who have participated in clinical studies of other drugs within 3 months before administration.
- •Subjects who have taken any prescription drugs, over-the-counter drugs, vitamin products, Chinese patent medicines, and Chinese herbal medicines within 1 month before administration.
- •Subjects who have been diagnosed with clinically significant diseases or have undergone major surgical procedures within 1 month before administration, or who are scheduled to undergo major surgery during the study.
- •Female subjects who test positive for pregnancy at screening or baseline or who are lactating.
- •Subjects who smoke more than 5 cigarettes or equivalent per day within 3 months before administration.
- •Subjects who have a history of drug abuse within the last 5 years, who have used narcotics within 3 months before administration, or who test positive in urine drug screening at the screening/baseline visit.
- •Subjects who have a history of regular alcohol consumption, which is defined as consumption of more than 7 units of alcohol per week for females or more than 14 units of alcohol per week for males (1 unit of alcohol equals 360 mL of beer, 45 mL of 40% liquor, or 150 mL of wine) within 3 months before administration, who take any alcohol-containing product within 48 h before administration, or who test positive in blood alcohol tests at the screening/ baseline visit.
- •Subjects with known symptoms of dermatitis or skin abnormalities at and around the site of administration.
- •Subjects who test positive for treponema pallidum antibody (TP-Ab), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C virus antibody (HCV-Ab), and human immunodeficiency virus antibody (HIV-Ab).
- •Patients with active tuberculosis, latent tuberculosis, or nontuberculous mycobacterial infection at screening;
- •Unless treatment records clearly documented by a specialist demonstrate that the patients have been adequately treated and may begin treatment with biological product (based on the medical judgment by the investigator and/or infectious disease specialist);
- •If needed, T-spot tests may be used to assist diagnosis of suspected tuberculosis.
- •Subjects with white blood cell count and neutrophil count below the lower limit of normal.
- •Female subjects with hemoglobin values less than 110 g/L or male subjects less than 120 g/L.
- •Subjects who cannot tolerate venous blood sampling, or who have a history of acupuncture syncope or hemophobia.
- •Subjects who still need or plan to engage in strenuous physical activity or exercise during the study.
- •Any other conditions that the investigator determines may affect the subject's provision of informed consent or compliance with the study protocol, or that the investigator deems unsuitable for participation in this study, or the subjects' participation in the study may affect the study results or their own safety.
研究组 & 干预措施
Test drug (T1): CBP-201 injection (pre-filled syringe, 150 mg/1 mL)
Experimental
Strength: pre-filled syringe, 150 mg/1 mL
干预措施: Test drug (T1): CBP-201 injection (pre-filled syringe, 150 mg/1 mL) (Biological)
Test drug (T2): CBP-201 injection (pre-filled syringe, 300 mg/2 mL)
Experimental
Strength: pre-filled syringe, 300 mg/2 mL
干预措施: Test drug (T2): CBP-201 injection (pre-filled syringe, 300 mg/2 mL) (Biological)
Reference drug (R): CBP-201 injection (vial, 150 mg/1 mL)
Active Comparator
Strength: vial, 150 mg/1 mL
干预措施: Reference drug (R): CBP-201 injection (vial, 150 mg/1 mL) (Biological)
结局指标
主要结局
AUC0-inf: Area under the plasma concentration-time curve from the start of administration to infinity
时间窗: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose
Pharmacokinetics similarity evaluation for test drug T1, test drug T2 and reference drug R
Cmax: Maximum concentration
时间窗: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose
Pharmacokinetics similarity evaluation for test drug T1, test drug T2 and reference drug R
AUC0-t: Area under the plasma concentration-time curve from the start of administration to the last measurable concentration time point T
时间窗: Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose
Pharmacokinetics similarity evaluation for test drug T1, test drug T2 and reference drug R
次要结局
- Area under the plasma concentration-time curve from the start of administration to infinity (AUC0-inf)(Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose)
- Maximum concentration (Cmax)(Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose)
- Area under the plasma concentration-time curve from the start of administration to the last measurable concentration time point T (AUC0-t)(Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose)
- Blood Pressure (systolic and diastolic blood pressures)(pre-dose, Day1, Day2, Day3, Day4, Day6, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57)
- Respiratory Rate(pre-dose, Day1, Day2, Day3, Day4, Day6, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57)
- Physical examination(pre-dose, Day6, Day15, Day29, Day57)
- Apparent clearance (CL/F)(Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose)
- Clinical laboratory test: Hematology - Hemoglobin (Hgb)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Hematology - lymphocyte count(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Hematology - eosinophil percentage(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Hematology - basophil count(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Biochemistry - Glucose (Glu)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Biochemistry - aspartate aminotransferase (AST)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Elimination half-life (t1/2)(Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose)
- Apparent volume of distribution (Vz/F)(Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose)
- Adverse events (AEs)(Up to 57 days post dosing)
- Injection site reactions(Day1, Day2, Day3, Day4, Day6, Day8, Day15, Day22, Day29, Day57)
- Time to peak (Tmax)(Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose)
- Terminal elimination phase rate constant (λz)(Pre-dose and 6hour, 24hour, 48hour, 72hour, 96hour, 120hour, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57 post-dose)
- Body Temperature (ear temperature)(pre-dose, Day1, Day2, Day3, Day4, Day6, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57)
- Clinical laboratory test: Hematology - Hematocrit (Hct)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Hematology - red blood cell count (RBC)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Hematology - platelet count(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Hematology - white blood cell count (WBC)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Hematology - monocyte percentage(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Hematology - mean corpuscular volume (MCV)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Biochemistry - lactate dehydrogenase (LDH)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Biochemistry - creatinine (Crea)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Biochemistry - phosphorus (P)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Biochemistry - uric acid (UA)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Coagulation - activated partial thromboplastin time (APTT)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Pulse(pre-dose, Day1, Day2, Day3, Day4, Day6, Day8, Day10, Day11, Day12, Day15, Day18, Day22, Day29, Day36, Day43, Day57)
- 12-lead electrocardiogram (ECG)(pre-dose, Day1, Day2, Day4, Day6, Day10, Day15, Day22, Day29, Day36, Day43, Day57)
- Clinical laboratory test: Hematology - neutrophil count(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Biochemistry - gamma-glutamyltransferase (γ-GGT)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Biochemistry - blood urea nitrogen (BUN)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Biochemistry - calcium (Ca)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Coagulation - fibrinogen (FIB)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Hematology - lymphocyte percentage(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Hematology - basophil percentage(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Biochemistry - alanine aminotransferase (ALT)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Biochemistry - albumin (ALB)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Biochemistry - triglycerides (TG)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Coagulation - prothrombin time (PT)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Hematology - neutrophil percentage(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Hematology - monocyte count(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Hematology - eosinophil count(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Hematology - mean corpuscular hemoglobin (MCH)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Urinalysis(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Biochemistry - total bilirubin (TBIL)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Biochemistry - sodium (Na)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Biochemistry - potassium (K)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Biochemistry - chlorine (Cl)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Biochemistry - total cholesterol (TC)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Biochemistry - creatine kinase (CK)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Pregnancy test(pre-dose, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Biochemistry - alkaline phosphatase (ALP)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Biochemistry - serum total protein (TP)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Biochemistry - direct bilirubin (DBIL)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Biochemistry - high-density lipoprotein cholesterol (HDL-C)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Biochemistry - low-density lipoprotein cholesterol (LDL-C)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Coagulation - International normalized ratio (INR)(pre-dose, Day6, Day15, Day29, Day43, Day57)
- Clinical laboratory test: Urine drug abuse screening(pre-dose)
- Immunogenicity: The positive rate and titer of anti-drug antibody (ADA), and the positive rate of neutralizing antibody (Nab, in case of ADA positive results)(pre-dose, Day11, Day29, Day43, Day57)
- Clinical laboratory test: Blood alcohol test(pre-dose)
- T-Spot(pre-dose)
- Clinical laboratory test: Infectious serology(pre-dose)
研究者
研究点 (1)
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