PHASE I STUDY OF RO7434656 IN JAPANESE HEALTHY VOLUNTEERS

JRCT ID: jRCT2031230387

Registered date:07/10/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy Volunteer
• Date of first enrollment: 15/02/2024
• Target sample size: 24
• Study type: Interventional
• Intervention(s): RO7434656: RO7434656 20,40,70 mg or placebo SC on Day 1

Outcome(s)

Primary Outcome

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 Outcome

other
Not applicable

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 44age old
• Gender: Male

Include criteria

- Healthy Japanese adult male subjects aged >= 18 and < 45 years at the time of signing the Informed Consent Form.
- The subject has a body mass index (body weight [kg]/height [m]^2) >= 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.)

Exclude 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.

Related Information

• Primary Sponsor: Toshihiro Nanki