Thromboembolic disease
Conditions
Interventions
Dose group 1:Both give KN060.KN060 was given in a single intravenous dose of 0.1mg/kg.
Dose group 2:The first 2 subjects were sentries, 1:1 randomized to receive KN060 or placebo
After 3 days of administration of 2 sentinels, administration of the remaining subjects in this group could be initiated
KN060 was given to the remaining 2 subjects in the second dose group. KN060 was given in a single&
Dose group 3:The first 2 subjects were sentries, 1:1 randomized to receive KN060 or placebo
The remaining subjects were assigned to KN060 or placebo in a ratio of five to one. KN060 was give
Dose group 4:The first 2 subjects were sentries, 1:1 randomized to receive KN060 or placebo
The remaining subjects were assigned to KN060 or placebo in a ratio of five to one. KN060 is given
Dose group 5:The first 2 subjects were sentries, 1:1 randomized to receive KN060 or placebo
Dose group 6:The first 2 subjects were sentries, 1:1 randomized to receive KN060 or placebo
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male or female subjects; 2. At the time of signing the informed consent, the age was between 18 and 55 years old (including the threshold); less than 3. Body mass index (BMI) is between 19.0 and 26.0 kg/m2 (excluding the cut-off value); The male weight is less than 250.0kg, and the female weight is 245.0kg; 4. APTT, PT, INR and platelet values are normal; 5. Understand the procedure of this research protocol, and be willing to accept and comply with the requirements of this protocol.
Exclusion criteria
Exclusion criteria: 1.Those who have a history of chronic diseases or have obvious systemic diseases, such as cardiovascular system, respiratory system, endocrine and metabolic system, urinary system, digestive system, blood system, autoimmune disease, neurological disease or psychiatric disease, bacterial or viral infection, etc.; 2.Allergic, or allergic to test drugs/similar drugs or excipients, or a history of multiple allergic diseases (two or more), or a history of specific reactions to certain substances; 3.Non-menopausal women who are expected to experience menstruation within one week of administration; 4.Those who have a history of drug abuse/dependence or drug abuse within 1 year prior to the test; 5.previous alcoholism or regular alcohol consumption (drinking more than 14 units of alcohol per week (1 unit = 360ml beer or 45ml 40% spirits or 150ml wine) in the 6 months prior to the trial); 6.people who drank excessive amounts of tea, coffee or caffeine-rich beverages (more than 8 cups, 1 cup = 250ml) every day within 3 months prior to screening; 7.Smokers who smoke more than 5 cigarettes a day within 3 months or who cannot stop smoking during the trial period; 8.Blood donation or blood loss =200ml within 3 months (excluding menstrual blood loss in women), or planning to donate blood or blood components during the trial or within 1 month after the trial; 9.Those who have participated in any drug clinical trials within 3 months and have used experimental drugs (including vaccine clinical trials); 10.Received vaccination within 1 month; There is a vaccination programme during the trial; Including inactivated vaccine, live attenuated vaccine, recombinant protein vaccine, recombinant adenovirus vaccine, RNA vaccine, DNA vaccine, etc. 11.Use any medicine (including prescription drugs, over-the-counter drugs, Chinese herbal medicine, etc.) or health care products within 14 days before the first medication; 12.Physical examination, vital signs examination, laboratory examination (blood routine, urine routine, fecal routine and occult blood, blood biochemistry), chest radiograph, abdominal color ultrasound (liver, bile, pancreas, spleen and kidney) and other abnormal results are clinically significant and may affect the evaluation of test results; 13.12-lead ecg showed abnormal heart rate, arrhythmia, and significant prolongation of QTc interval (male QTc CF> 450ms, female. 470ms) may affect the evaluation performance of the test results; 14.Screening for infectious diseases: screening positive persons for hepatitis b (including hepatitis B and C), AIDS and syphilis; 15.Alcohol breath test positive; 16.Positive urine drug abuse screening, including morphine, methamphetamine, ketamine, TETRAhydrocannabinolic acid, and mdMA; 17.Have a history of hemorrhagic diseases and have a clear risk of coagulopathy; 18.Male subjects: refused or were unable to use effective contraception from signing the informed consent until 3 months after the last follow-up; Effective methods of contraception include: vasectomy, scientific use of male condoms, tubal ligation or hysterectomy, implantation of intrauterine devices, etc.; 19.Female subjects: positive pregnancy test; Refusal or inability to use effective contraception from signing informed consent until 3 months after the last follow-up; Effective methods of contraception include tubal ligation or hysterectomy, implantation of an intrauterine device, vasectomy or scientific use of male condoms. 20.subje
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma antibodies;Physical examination;Laboratory examination;ECG examination;vital signs; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed