F(ab')2 antivenom of Daboia russelii siamensis
Conditions
Interventions
Experimental group (pre-test):Inject 2500U F(ab')2 antivenom of Daboia russelii siamensis
Control group (pre-test):Placebo compare
Experimental group 1:Inject 5000U F(ab')2 antivenom of Daboia russelii siamensis
Control group 1:Placebo compare
Experimental group 2:Inject 10000U F(ab')2 antivenom of Daboia russelii siamensis
Control group 2:Placebo compare
Sponsors
Shanghai Xuhui Central Hospital
Eligibility
Sex/Gender
All
Age
21 Years to 38 Years
Inclusion criteria
Inclusion criteria: 1) 18 years old =50 kg, female >=45 kg; body mass index (BMI) within the range of 19-26 kg/m2 (including 19 and 26); 3) The important indicators of physical examination, vital signs examination, electrocardiogram examination, and laboratory examination are normal or abnormal, which is judged by the investigator to have no clinical significance; 4) Reliable contraceptive measures will be taken during the trial period and 3 months after the start of administration; 5) Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent, and be able to complete the entire trial process according to the trial requirements.
Exclusion criteria
Exclusion criteria: 1) People who are known to have a history of allergy to the test preparation and any of its ingredients, who have previously been injected with tetanus antitoxin, rabies virus antiserum and antivenom, and those who have a positive skin test for the test drug before the clinical trial; 2) The researcher determines that the subject has a disease that affects drug absorption, distribution, metabolism and excretion or can reduce compliance (cardiovascular, liver, kidney, digestive tract, immune, blood, endocrine, metabolism, cancer, neuropsychiatric wait); 3) Those who have donated blood or lost blood >= 400 mL within 3 months before enrollment; 4) Those who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products within 2 weeks before screening; 5) Those who have participated in other drug clinical trials within 3 months before enrollment; 6) Current or former drug addicts or alcohol addicts, current or former alcoholics (drinking more than 14 standard units per week. 1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of alcohol is 40% spirits or 150 mL of wine), or a positive alcohol breath test; 7) Those who smoked more than 10 cigarettes a day within 6 months before screening; 8) Vegetarians or those with dietary restrictions; 9) Those who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab) and Treponema pallidum antibody; 10) Chest X-ray (posteroanterior) examination results are abnormal and have clinical significance; 11) Those who have a positive pregnancy test (applicable to women); 12) Those who have other factors that the researchers think are not suitable for participating in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| F(ab')2 antivenom of Daboia russelii siamensis;ADA;Tmax;Cmax;AUC0-t;AUC0-inf;?z;t1/2;%AUCex;Cl;vital signs;physical examination;12-lead ECG;Clinical laboratory test indicators (blood routine, urine routine, blood biochemistry);AE and SAE;Vc;Vt; | — |
Secondary
| Measure | Time frame |
|---|---|
| Neutralization ability; | — |
Countries
China
Contacts
Public ContactYun Liu
Shanghai Xuhui Central Hospital
Outcome results
None listed