A condition requiring urgent blood transfusion
Conditions
Interventions
This is a single-center study conducted in healthy Japanese adults to evaluate the safety of NMU-HbV following intravenous administration
Cohort 1: 100 mL (maintenance infusion rate: 2.5 mL/min)
Cohor
Sponsors
Matsumoto Masanori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Healthy Japanese adults 2)Written informed consent obtained prior to screening 3) Age at the time of obtaining informed consent: 18 years or older and less than 50 years 4) Body weight at the time of screening: 40 kg or more and less than 85 kg 5)Able to abstain from smoking during hospitalization 6)Blood hemoglobin concentration at screening within the following ranges: Males: >=12.0 and =10.0 and <=14.5 g/dL 7)Able to participate in all examinations required in this clinical study and are expected to complete the study
Exclusion criteria
Exclusion criteria: 1)History of any clinically significant disease or clinically significant surgery within 4 weeks prior to enrollment 2) Hepatic, renal, or cardiac dysfunction requiring clinical treatment, or a history thereof 3) History of allergy to drugs or liposomal formulations 4) History of alcohol or drug dependence 5)Whole blood donation of >=400 mL within 4 months prior to screening, >=200 mL within 1 month prior to screening, or apheresis within 14 days prior to screening 6) Use of prescription or over-the-counter medications (including crude drugs) within 14 days prior to screening visit (excluding topical agents with no systemic exposure, such as disinfectants and ophthalmic solutions, that are considered not to affect the study) 7)Planned participation in another clinical study or post-marketing clinical study during the study period 8)Receipt of an investigational medicinal product in another clinical study within 4 months prior to screening (based on the last administration date) 9)Prior receipt of the investigational drug (NMU-HbV) 10) Clinically significant abnormal findings in vital signs or laboratory test results at screening that suggest a condition requiring treatment or organ dysfunction (unless the investigator or sub-investigator judges that participation in the study is acceptable) 11) Positive results for any of the following tests at screening: infectious disease tests (HBs antigen, syphilis tests [TP antibody (CLEIA) or RPR (LA)], HCV antibody, or HIV antibody) or urine drug screening 12)Women of childbearing potential who do not agree to use contraception* from the time of informed consent through the study period and until 12 weeks after the end of the study *Definition of women of childbearing potential Women from menarche to menopause are considered to have reproductive potential unless they have undergone permanent sterilization. Women meeting any of the following criteria are not considered to be of childbearing potential Pre-menarche Documented hysterectomy Documented bilateral salpingectomy Documented bilateral oophorectomy Postmenopausal (defined as at least 12 months since the last menstrual bleeding without an alternative medical cause) 13) Male subjects with a female partner of childbearing potential who do not agree that the subject or the partner will comply with contraception requirements, from the time of informed consent through the study period and until 12 weeks after the end of the study 14) Any other condition that, in the opinion of the principal investigator or sub-investigator, makes the subject unsuitable for participation in the study (e.g., anticipated difficulty in complying with study visits or subject management). * Acceptable methods of contraception are medically appropriate methods (e.g., condoms, oral contraceptives) 1) Participation in another clinical study and receipt of an investigational product between screening and admission 2) Use of any other medications within 14 days prior to admission 3)Receipt of medical treatment from a physician who is not involved in the study at the time of admission 4) Intake of food or beverages containing caffeine or alcohol within 3 days prior to initiation of investigational product administration 5) Any other condition that, in the opinion of the principal investigator or sub-investigator, makes the subject unsuitable for participation in the study (e.g., ineligibility bas
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety - Incidence and frequency of adverse events up to 14 days after investigational product administration - Medically significant changes within 72 hours (3 days) after investigational product administration Safety assessments will be based on subjective and objective symptoms, vital signs, electrocardiograms, and clinical laboratory test results compared with baseline (pre-dose) values | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics Plasma concentration-time profiles of NMU-HbV from immediately after administration through Day 15 will be evaluated. The following pharmacokinetic parameters will be estimated: - Maximum plasma concentration (Cmax) - Time to reach maximum plasma concentration (Tmax) - Area under the plasma concentration-time curve (AUC) - Elimination half life (T1/2) | — |
Contacts
Public ContactMasato Kasahara
Nara Medical University Hospital
Outcome results
None listed