Hemophilia
Conditions
Interventions
S1:single subcutainous injection 30mg (4 subjects receive AP017 and 2 receive placebo, first 2 subjects were sentries)
S2:single subcutainous injection 100mg (8 subjects receive AP017 and 2 receive placebo)
S3:single subcutainous injection 200mg (8 subjects receive AP017 and 2 receive placebo)
S4:single subcutainous injection 300mg (8 subjects receive AP017 and 2 receive placebo)
S5:single subcutainous injection 450mg (6 subjects receive AP017 and 2 receive placebo, first 2 subjects were sentries)
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1) Healthy male subjects age from 18~50 years old (including 18 and 50); 2) Body weight >= 50kg, body mass index (BMI) of 19.0 to 26.0 kg/m2 (including 19.0 and 26.0 kg/m2); 3) Male subjects and their mates must consent to take one or more non-drug contraceptive measures (such as completely abstinence, intrauterine ring, ligation, etc.), and no plan of sperm donation; 4) Subjects shall completely understand the objectives, nature, method and possible adverse reactions, volunteer to participate in the trial and sign the ICF. 5) Subjects is able to have good communication with the investigators and complete the study in accordance with the clinical protocol.
Exclusion criteria
Exclusion criteria: 1) Those who were allergic to the test drug or any excipient, who had a history of allergy to monoclonal antibodies, and had allergic constitution (two or more drugs or food allergy). 2) those with a history of coronary artery and/or peripheral atherosclerosis or congestive heart failure. 3) With abnormal protein C and protein S activity, or other known prothrombotic conditions. 4) Those who have clinical symptoms or a history or family history of disseminated intravascular coagulation disorder or thromboembolism (particularly deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, cerebrovascular accident, ischemic heart disease, transient ischemic attack), or who are judged by the investigator to be at high risk for thromboembolism. 5) Who with a history of chronic disease or current clinical disease of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematologic, immunological, psychiatric and metabolic abnormalities, bacterial or viral infection, or any other disease that may interfere with the test results. 6) Who had undergone surgery within 3 months before the trial that was judged by the investigators to affect the absorption, distribution, metabolism, and excretion of drugs; Or had undergone surgical procedures within 4 weeks before the trial or were planning to undergo surgical procedures during the study. 7) Occurrence of any acute disease within 28 days before administration. 8) Subjects with abnormal venous access or intolerance to venipuncture or subcutaneous injection, or with a history of dizziness and bleeding. 9) Use of any medication within 14 days prior to dose, including prescription medications, nutritional supplements, and over the counter medications. 10) Received any biologic agent (including antibodies or derivatives thereof) within 16 weeks (or 5 half-lifetimes, whichever was longer) before dose. 11) Received any live vaccine within 60 days prior to administration or any inactivated vaccine within 28 days prior to administration, or who intended to receive the vaccine during the study period. 12) Abnormal vital signs (systolic blood pressure =140 mmHg, diastolic blood pressure =90 mmHg; Pulse 100 beats/min; Body temperature (ear temperature) 37.7 degree) or abnormal electrocardiogram (QTcB >=450 ms) or abnormal findings on physical examination, abdominal ultrasound, or chest X-ray of clinical significance (subject to the judgment of the clinical research physician). 13) Laboratory findings were abnormal and clinically significant as judged by the study physician. 14) Test positive for Hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, treponema pallidum antibody. 15) Test positive for Urine drug abuse screening (methamphetamine, ketamine, dimethylenedioxyamphetamine, cannabis, morphine, cocaine); or alcohol breath test result greater than 0.0 mg/100 mL. 16) Drug abusers or those who had used soft drugs (e.g., cannabis) within 3 months or hard drugs (e.g., cocaine, phenzyclidine) within 1 year before the test. 17) Heavy drinkers or regular drinkers in the 6 months before the trial, who consumed an average of more than 14 drinks per week (1 drink of alcohol ˜360 mL of beer or 45 mL of 40% spirits or 150 mL of wine), or who were unable to abstain during the trial. 18) Participants who smoked an average of more than 5 cigare
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety and tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK ;PD;Immunogenicity; | — |
Countries
China
Contacts
Public ContactXueying Ding
Shanghai General Hospital
Outcome results
None listed