Reversal of Neuromuscular Blockade
Conditions
Interventions
0.5 mg/kg, 2 mg/kg, 4 mg/kg, 8 mg/kg, 16 mg/kg, 24 mg/kg, 32 mg/kg:Two subjects in each cohort received 0.9% NaCl solution.
0.5 mg/kg:Two subjects received Adamgammadex Sodium for Injection.
2 mg/kg, 4 mg/kg, 8 mg/kg, 16 mg/kg, 24 mg/kg, 32 mg/kg:Six subjects in each cohort received Adamgammadex Sodium for Injection.
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1 Aged 18-40 years (including thresholds), male or female; 2 Body mass index (BMI=weight/height2) is between 19-26 kg/m2 (including thresholds), and male body weight is >= 50 kg and =45 kg and <= 85 kg; 3 At screening, no clinically significant abnormality is found in medical history, physical examination, vital signs, chest X-ray, and 12-lead ECG; 4 At screening, the results of laboratory tests are normal or are abnormal NCS. The tests include blood routine, urinalysis, blood biochemistry, blood ß2 microglobulin, serum virology (hepatitis B virus, hepatitis C virus, human immunodeficiency virus), syphilis, and coagulation function; 5 Agree to follow the study protocol and follow-up plan and sign the informed consent.
Exclusion criteria
Exclusion criteria: A subject shall not be included in this study if the subject: 1 has existing diseases of digestive system, urinary system, cardiovascular system, blood system, respiratory system, neuropsychiatric system, or endocrine and metabolic system with clinical significance; 2 has a history of genetic bleeding disorders, coagulopathy, non-traumatic bleeding (requiring treatment), thromboembolism, or any existing disease associated with the risk of bleeding (including coagulopathy, thrombocytopenia [platelet count 1.5); 3 has any febrile disease within seven days pre-dose; 4 has a history of severe systemic allergy caused by any reason, suspected hypersensitivity to cyclodextrin, or hypersensitivity to multiple drugs; 5 has any confirmed allergic reactions (e.g., food allergy, drug allergy, specific allergic reactions, or asthma attack) affecting his/her eligibility determined by the investigators; 6 has a medication history of sugammadex sodium; 7 Abnormal ECG with clinical significance determined by the investigators, or QTc (calculated by Fridericias correction formula: QTc= QT/(RR)^0.33) > 430 ms (male) or > 450 ms (female); 8 has abnormal blood pressure or heart rate (systolic blood pressure > 140 mmHg or 90 mmHg or 100 bpm) at screening or admission.); 9 has acute or chronic infectious diseases with clinical significance at screening or admission, or any positive test result of hepatitis C antibody (HCVAb), human immunodeficiency virus antibody (HIVAb), hepatitis B surface antigen (HBsAg), or syphilis at screening; 10 has a medication history of other steroid hormone drugs, e.g., fusidic acid, toremifene citrate, tamoxifen citrate, clomiphene citrate, progesterone, norethindrone, testosterone, and prednisone within three months prior to the signing of the informed consent; 11 has a history of taking any medicine or dietary supplement within 14 days pre-dose; is within five half-lives of any medicine or dietary supplement with a half-life longer than 14 days. 12 has any conditions affecting the drug absorption or PK parameters of the IMPs; 13 has a history of blood donation within three months prior to the signing of the informed consent, or blood donation plan during the study; 14 has participated in any other drug or device clinical trial within three months prior to the signing of the informed consent, or plans to participate in other clinical trials during the study; 15 smokes more than ten cigarettes or equivalent per day; 16 is an alcoholic or has drunk alcoholic beverages within 48 h pre-dose; 17 is a male unwilling to use effective contraceptives during the study; is pregnant or lactating, or a female with potential fertility unable or unwilling to use effective contraceptives during the study; 18 is expected to has menstruation during the study; 19 has drug abuse or medical, psychological, or social conditions that may interfere with the study or affect the assessment of the study results; 20 has any unstable situation or any other situation that may endanger the safety and study compliance; 21 is determined to be unfit for the study by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hematology;Biochemistry;blood ß2 microglobulin;Urinalysis;Coagulation function;Physical examination;Vital signs;ECGs;Serum tryptase; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK blood;PK urine; | — |
Countries
China
Contacts
Public ContactJin Liu, Yingying Jiang
West China Hospital, Sichuan University
Outcome results
None listed