Healthy Volunteer
Conditions
Interventions
RO7434656: RO7434656 20,40,70 mg or placebo SC on Day 1
Sponsors
Toshihiro Nanki
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Healthy Japanese adult male subjects aged >= 18 and = 18.5 to < 25.0 kg/m^2 at screening. - The subject has no evidence of active or chronic disease based on a detailed medical and surgical history and the results of a physical examination, vital signs, 12 lead ECG, or clinical laboratory tests. - The subject has received a serogroup B meningococcal vaccine or a tetravalent (Serotypes A, C, Y, and W-135) meningococcal vaccine within 5 years prior to the first dose of investigational product. (Vaccination must be given at least 14 days prior to administration of investigational product if it is not possible to document that the vaccination was given within 5 years prior to administration of investigational product, or if 5 years have elapsed since vaccination between administration of investigational product and the last visit.) - The subject has received pneumococcal vaccine and Haemophilus influenzae type b vaccine at the age of 18 years or older. (Vaccination must be given at least 14 days prior to investigational product administration if it is not possible to document that the vaccine was given at the age of 18 years or older.)
Exclusion criteria
Exclusion criteria: - Carriers of Neisseria meningitidis as determined by nasopharyngeal swab culture. - Individuals in social settings that increase the risk of infection with bacteria that can cause encapsulated infections (e.g., living or working in a student's dormitory, nursing home, etc.). - The subject has a history of or current bacterial meningitis, pneumonia, or other significant pulmonary infection, is scheduled for a procedure or surgery during the screening period or the study period, or has an abnormal electrocardiogram (ECG) or a history of such procedures. - The subject was unwilling to abstain from smoking for a specified period of time prior to receiving investigational product and throughout the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| phamacokinetics: Plasma pharmacokinetics of RO7434656 following a single SC administration phamacodynamics: Plasma FB concentrations and other complement pathway biomarkers following a single SC dose safety: Evaluation of the incidence of adverse events including serious adverse events, laboratory test values, 12 lead ECG, and vital signs | — |
Secondary
| Measure | Time frame |
|---|---|
| other Not applicable | — |
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed