None listed
Conditions
Interventions
Drug : A dose-block randomized, single dosing, intravenous administration
1) 1Cohort: 0.02mmol/kg HNP-2006(6) or placebo(2)
2) 2Cohort: 0.05mmol/kg HNP-2006(6) or placebo(2)
3) 3Cohort: 0.10mmol/kg
Sponsors
Hana Pharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Healthy adults aged = 19 to < 55 years at the time of screening test 2.Body mass index (BMI) of = 18.5 to < 27.0 ? BMI = Body weight (kg)/[height (m)2] 3.For females, one of the following must be met: - Menopause (no spontaneous menses for at least 2 years) - Surgical sterilization (being sterile by hysterectomy or bilateral oophorectomy, tubal ligation, or other methods) 4.For males who are sexually active with females of childbearing potential, agreed to use contraception (use of double barrier contraceptive methods such as condom with diaphragm or cervical cap) and not to donate sperm during the study period and for at least 8 weeks after the last dose of the investigational product (if male subjects or their female partners are infertile, the above contraceptive methods are not needed) 5.Voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information
Exclusion criteria
Exclusion criteria: 1.Presence or history of clinically significant hepatobiliary (e.g., severe hepatic impairment), renal (e.g., acute or chronic severe renal impairment, acute renal failure due to hepatorenal syndrome, and acute renal failure before and after liver transplantation), nervous (e.g., spastic disorders such as epilepsy), immune, respiratory, endocrine, and cardiovascular (e.g., congenital long QT syndrome and heart failure) diseases, malignant tumor, or mental diseases 2.Family history of long QT syndrome or dysrhythmia after administration of a drug prolonging the repolarization cycle of action potential 3.Medical history of hypersensitivity to contrast agents or any components of contrast agents, bronchial asthma or allergy, and clinically significant hypersensitivity 4.Subjects who met any of the following in the screening test - AST, ALT in blood > 1.5 x the upper limit of normal - Total bilirubin in blood > 1.5 x the upper limit of normal - eGFR < 90 mL/min/1.73m2 based on CKD-EPI formula 5.Systolic blood pressure > 150 mmHg or < 90 mmHg or diastolic blood pressure > 100 mmHg or < 60 mmHg in the vital signs measured in the sitting position after at least 5 minutes rest. 6.Positive serologic test result (hepatitis B, hepatitis C, human immunodeficiency virus, and syphilis) 7.History of drug abuse or positive result in urine drug screening test 8.Gadolinium-based contrast agents (e.g., Gadovist and Dotarem) administered within 30 days prior to the administration of the investigational product 9.Use of any prescribed drugs or herbal medicines within 14 days, or any over-the-counter (OTC) drugs including dietary supplement and vitamins within 7 days prior to the administration of the investigational product, which is considered to affect this study or the safety of the subjects in the opinion of the investigator 10.Participated in another clinical study (including bioequivalence study) and received an investigational product within 90 days [6 months as of 12 Jun 2019] prior to the administration of this investigational product (The period may be extended for biological products considering a half-life) 11.Donated whole blood within 60 days, or donated blood components within 30 days prior to the administration of the investigational product 12.Received a blood transfusion within 30 days prior to the administration of the investigational product 13.Determined to be ineligible to participate in the study by the investigator due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUClast, AUCinf, Cmax, Tmax, t1/2, CL, Vd, MRT of HNP-2006 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability evaluation (Adverse Events, Physical Examination, Vital Signs, Clinical Laboratory Test 12-lead ECG, etc.) | — |
Countries
Korea, Republic of
Contacts
Public ContactKiYoung Huh
Seoul National University Hospital
Outcome results
None listed