Healthy Volunteers
Conditions
Interventions
BRY10: SC injection
Sponsors
Awaya Norihiro
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Signed ICF. - Able to comply with the study protocol, in the investigators judgment. - Have a body mass index (body weight [kg]/height [m]^2) >=18.5 kg/m^2 or =18.5 kg/m^2 or =50 kg at screening. - Have no findings indicating an active or chronic disease, based on detailed hearing of medical and surgery histories and the results of physical examination, vital sign measurements, ECG, and laboratory tests.
Exclusion criteria
Exclusion criteria: - Clinically significant abnormal ECG at screening. - Current cardiovascular, renal, hepatic, gastrointestinal, hematologic, immune, neurologic, endocrine, metabolic, or pulmonary disorder or a history of any of these disorders and impaired renal, hepatic, or cardiopulmonary function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety, phamacokinetics, other - Frequency, severity and relationship of adverse events including serious adverse events (SAE) to BRY10 - Laboratory values, vital signs and ECGs - Plasma concentrations and pharmacokinetic parameters (Cmax, Tmax, AUC, T1/2, etc.) | — |
Secondary
| Measure | Time frame |
|---|---|
| phamacokinetics, other - Immunogenicity - Effct of Ethinic difference on pharmacokinetics | — |
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed