Healthy Adult Male Volunteers
Conditions
Interventions
Single intravenous infusion of the investigational drug
Sponsors
Imura Futoshi
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Japanese men with 18 to 45 years of age at screening - In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations, as assessed by the investigator (or delegated person) at screening and on Day -1
Exclusion criteria
Exclusion criteria: - History of clinically significant medical conditions including, but not limited to, diseases of the renal, hepatic, respiratory, gastrointestinal, cardiovascular, neurological, musculoskeletal, immunological, haematological, endocrine, and metabolic systems, as well as oncological, psychiatric, dermatological, and allergic diseases (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Number of treatment-emergent adverse events, including type, intensity, and causality. - Change from baseline in vital signs, 12-lead electrocardiogram (ECG), haematology, clinical chemistry, haemostasis, and urinalysis parameters after a single IV dose infusion. | — |
Contacts
Public ContactChina Saga
Ferring Pharmaceuticals Co., Ltd.
Outcome results
None listed