Treatment for children and adults with acute lymphoblastic leukemia from birth to 18 years of age.
Conditions
Interventions
Test group:asparaginase injection
Reference group:Oncaspar
Sponsors
The Second Affiliated Hosptial of Xingtai Medical College
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Subjects who have to give informed consent to the study before the trial, sign a written informed consent voluntarily, and can complete the study according to the requirements of the scheme; 2. Gender: Chinese healthy adult male subjects. 3. Age at screening: male healthy volunteers aged 18-45 years(including boundary value). 4. Subjects with weight >= 50.0kg at the time of screening. Body mass index is in the range of 19.0-26.0 kg / m2 (including boundary value), body mass index = weight (kg) / height 2 (M2). 5. The body surface area (BSA) of male healthy volunteers ranged from 1.6 to 2.0m2 (including the threshold value). Body surface area (BSA) calculation formula: Chinese adult male BSA = 0.00607 x height + 0.0127 x weight -0.0698 (Note: height unit is cm, weight unit is kg). 6. Laboratory examination items during screening: ast, alt, total bilirubin and amylase must be within the normal range; other laboratory examination items, physical examination, vital signs examination, chest CT examination and ECG examination are normal or abnormal subjects without clinical significance judged by researchers. 7. Subjects who can communicate well with researchers and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Those who are enrolled in other clinical trials and take the corresponding test drugs within 3 months before the trial, or who are participating in other clinical trials; 2. People who have travel or residence history in Wuhan city and surrounding areas, or other communities with case reports 14 days before screening; those who have contact history with new coronavirus infection 14 days before screening; People in Wuhan and surrounding areas, or those with a history of fever or respiratory symptoms from a community with a case report; 3. Hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody or human immunodeficiency virus antibody test results of screening period are abnormal clinical significance; 4. There are cardiovascular, liver, kidney, digestive tract, skin, endocrine, blood system, respiratory system, nervous system (such as epilepsy, etc.), infection, malignant tumor, and other medical history (such as history of otitis media) that the researchers judge to have clinical significance Or patients with otitis media, acute thrombosis, a history of pancreatitis, and a history of significant bleeding) or those with existing diseases; 5. Those who have undergone major surgical operations within 6 months before screening, or who plan to perform operations during the study period, and those who have undergone operations that will affect the absorption, distribution, metabolism, and excretion of drugs (except for appendicitis and hernia repair surgery). 6. Those who have received vaccination within 28 days before screening; 7. The alcohol breath test result before the test is greater than 0.0mg / 100mL, or drinking more than 14 standard units (1 standard unit contains 14g alcohol, such as 360mL beer or 45mL alcohol with 40% alcohol content) within 3 months before screening Spirits or 150mL of wine, and those who cannot accept alcohol prohibition after the selection to the entire test period; 8. Those who smoked more than 5 cigarettes per day in the 3 months before screening, or used tobacco products, nicotine products (patches, chewing gum, etc.); and those who could not accept no-smokers from the time they were selected until the entire trial; 9. Those who have a history of allergy to pepase or L-asparaginase and its related compounds and any ingredients, or who are allergic to two or more drugs (or food); 10. Drug abuse before the test and a positive drug test or a history of drug abuse within 5 years before the test (morphine, methamphetamine, ketamine, dimethylenedioxyamphetamine, tetrahydrocannabinolic acid, cocaine Etc.); 11. Those who donated or lost blood >= 400mL within 3 months before the test, or plan to donate blood or blood components within the study period or within 3 months after the end of the study; 12. The subjects (or those partners) are unwilling or unable to take one or more contraceptive measures during the test period to 3 months after the end of the test; or the subjects during the test period and within 3 months after the end of the test Planner for female insemination; 13. Those who have used any prescription drugs, non-prescription drugs, Chinese herbal medicines, health products within 28 days before the trial; 14. Study any beverages or foods that are rich in grapefruit ingredients or other substances that affect the absorption, distribution, metabolism, excretion, etc. of the drug within 48 hours before the first dose; 15. Those who have been drinking too much (more
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| activity of asparaginase;concentration of asparagine;analysis of anti-aspartase antibody (ADA) and neutralizing antibody (Nab); | — |
Countries
China
Contacts
Public ContactGuo Fengxue
The Second Affiliated Hospital of Xingtai Medical College
Outcome results
None listed