Infectious Diseases
Conditions
Interventions
Part 1 SAD Cohort 1 (125 mg):Intravenous infusion of JKN2501 injection 125 mg over 3 hours
Part 1 SAD Cohort 2 (500 mg):Trial group: JKN2501 injection 500 mg, placebo-controlled. (Randomly enrolled 6 cases of JKN2501 and 2 cases of placebo)
Part 1 SAD Cohort 3 (1500 mg):Trial group: JKN2501 injection 1500 mg, placebo-controlled. (Randomly enrolled 6 cases of JKN2501 and 2 cases of placebo)
Part 1 SAD Cohort 4 (3000 mg):Trial group: JKN2501 injection 3000 mg, placebo-controlled. (Randomly enrolled 6 cases of JKN2501 and 2 cases of placebo)
Part 1 SAD Cohort 5 (6000 mg):Trial group: JKN2501 injection 6000 mg, placebo-controlled. (Randomly enrolled 6 cases of JKN2501 and 2 cases of placebo)
Part 2 MAD Cohort 1 (500 mg):Trial group: JKN2501 injection 500 mg (q8h), placebo-controlled. (8 cases were randomly assigned to the JKN2501 injection group and 2 cases to the placebo group.)
Part 2 MAD Cohort 2 (1500 mg):Trial group: JKN2501 injection 1500 mg (q8h), placebo-controlled. (8 cases were randomly assigned to the JKN2501 injection group and 2 cases to the placebo group.)
Part 2 MAD Cohort 3 (3000 mg):Trial group: JKN2501 injection 3000 mg (q8h), placebo-controlled. (8 cases were randomly assigned to the JKN2501 injection group and 2 cases to the placebo group.)
Sponsors
The Third Hospital of Changsha
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. The subject voluntarily signs an informed consent form, understands and complies with the study procedures and restrictions, is able to complete the trial as planned, and is able to communicate effectively with the investigator. 2. Healthy subjects aged 18-45 years (inclusive) and of either sex were selected 3. Body mass index (BMI) is 19.0-26.0 kg/m^2 (including both ends), and the weight of male is >=50kg, female is >=45kg 4. Life signs, physical examination, electrocardiogram, laboratory examination, chest X-ray and abdominal B-ultrasound were judged by the investigator as normal or abnormal without clinical significance. 5. Participants must guarantee and agree to use non-drug contraceptive methods (e.g., condoms or intrauterine devices) with their sexually active partners for 90 days from the date of signing the INFORMED consent form until the last dose, and not to donate sperm or eggs for 90 days from the date of signing the INFORMED consent form until the last dose.
Exclusion criteria
Exclusion criteria: 1. Pregnancy (or positive blood pregnancy test), lactation; or occurrence of unprotected sexual intercourse within 2 weeks prior to administration of the investigational drug; 2. Any current or previous diseases or conditions of the cardiovascular, respiratory, digestive, endocrine, metabolic, neurological, urinary, reproductive, immune, or psychiatric systems that are judged by the investigator to be clinically significant or may affect the safety of the subject or cause interference with the subject's participation in this clinical trial; 3. Use of any drugs that inhibit or induce hepatic drug metabolism (see Appendix 4) within 4 weeks prior to administration of the investigational drug; or use of any medication, including prescription drugs, over-the-counter drugs, herbal medicines, traditional Chinese medicines, vitamins, health supplements, etc., within 2 weeks prior to administration of the investigational drug; or plan to use the above medications during the trial period; 4. Previous surgeries that may affect the results of the clinical trial (including but not limited to any ophthalmic surgery, cholecystectomy, partial gastrectomy, etc., excluding minor surgeries such as superficial lipoma resection), or severe infection, severe trauma, or major surgery within 3 months prior to screening, or planned surgery during the trial period; 5. History of febrile illness or evidence of active infection within 2 weeks prior to screening; 6. Blood loss or blood donation exceeding 400 mL within 3 months prior to screening (excluding menstrual blood loss in females); or receipt of blood transfusion or blood products; or plan to donate blood during the trial period or within 30 days after the last dose; 7. History of food or drug allergy, or allergy to the investigational drug or any related drugs or excipients; 8. History of alcoholism (i.e., consumption of more than 28 standard units of alcohol per week) or regular alcohol consumption within 6 months prior to screening (i.e., consumption of more than 14 standard units of alcohol per week) or unwillingness to abstain from alcohol or alcohol-containing beverages from 48 hours before the first dose to the end of the trial period. (1 standard unit contains 14g of alcohol, equivalent to 360 mL of beer, 45 mL of spirits with 40% alcohol content, or 150 mL of wine); 9. Average daily smoking of >=5 cigarettes within 3 months prior to screening or unwillingness to abstain from smoking from 48 hours before the first dose to the end of the trial period; 10. History of drug abuse, or positive urine drug screening at baseline (D-1); 11. Positive alcohol breath test at baseline (D-1); 12. Participation in another clinical trial with intervention measures within 3 months prior to screening for this trial, or planned participation in other clinical trial groups during this study period; 13. Estimated glomerular filtration rate (eGFR) < 90 mL/min calculated using the CKD-EPI formula; 14. Total calcium below the lower limit of normal at screening; 15. Venous access deemed unsuitable for PK sampling or intravenous infusion by the investigator, or history or evidence of adverse symptoms related to intravenous infusion, blood sampling, or blood donation, judged by the investigator as unsuitable for participation; 16. Daily consumption of excessive tea, coffee, and/or caffeinated beverages (more than 8 cups, 1 cup ˜ 250 mL) within 3 months prior to screening; 17. Consumption of grapefruit, pomelo, caffeine- or xa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability Assessment (Vital Signs, Physical Examination, Clinical Laboratory Tests, 12-lead Electrocardiogram, Adverse Events and Serious Adverse Events) (Part I);Safety and Tolerability Assessment (Vital Signs, Physical Examination, Clinical Laboratory Tests, 12-lead Electrocardiogram, Adverse Events and Serious Adverse Events) (Part II); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic Parameters (Tmax, Cmax, C72h, AUC0-72h, AUC0-t, AUC0-8, CL, t1/2, MRT) (Part I);Urinary and Fecal Pharmacokinetic Parameters (Ae0-168h urine/feces, Fe0-168h urine/feces, Metabolite Identification) (Part I);Concentration-QT Analysis (Correlation between QT Interval Change and Plasma Drug Concentration) (Part I);Pharmacokinetic Parameters (Tmax, Cmax, t1/2, AUC0-t, AUC0-8, CL, Tmax,ss, Cmax,ss, Cmin,ss, Cav,ss, AUCss, DF, Rac(Cmax), Rac(AUC), Fluctuation Index) (Part II); | — |
Countries
China
Contacts
Public ContactLi Xin
The Third Hospital of Changsha
Outcome results
None listed