Healthy volunteers Other
Conditions
Interventions
Participants will be randomized to Group 1 or Group 2 in a 1:1 ratio to receive RO7434656. Randomization will be done based on the treatment list generated by independent representatives of the sponso
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Overtly healthy and has no evidence of active or chronic disease as determined by detailed medical and surgical history and the results of a physical examination, vital signs, 12 lead electrocardiogram (ECG), or clinical laboratory tests. 2. Body weight greater than or equal to 50 kilograms (kg) and a body mass index within the range 18.5 to 28.0 kilogram per meter squared (kg/m2) 3. Vaccination against Neisseria meningitidis within 5 years prior to initiation of study treatment 4. Vaccination against Streptococcus pneumoniae within 5 years prior to initiation of study treatment
Exclusion criteria
Exclusion criteria: 1. Treatment with any other investigational drug, biological agent, or device within 4 weeks or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment. 2. Received or is scheduled to receive any live vaccine within 4 weeks prior to the first dose of investigational product or within 90 days after receipt of the investigational product. 3. Received or is scheduled to receive an inactivated vaccine within 1 week prior to the first dose of investigational product or within 90 days after receipt of the investigational product. 4. History or evidence of any medical conditions (e.g., gallbladder removal, malabsorption syndrome, or hepatic disorder) potentially altering the absorption, distribution, metabolism, or elimination of drugs. 5. Social circumstances that increase the risk of infection with bacteria that can cause encapsulated infections 6. History or presence of clinically significant cardiovascular disease, renal disease, hepatic disease, gastrointestinal disease, hematological disease, immunological disease, neurological disease, endocrine disease, metabolic disease, pulmonary disease, or history of any of these diseases with renal, hepatic, or cardiopulmonary dysfunction. 8. Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the single SC dose of RO7434656.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration and PK parameters of RO7434656 measured using blood samples collected at pre-dose and multiple timepoints post-dose from Day 1 to Day 90 of the Observation Period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline of plasma Factor B levels following subcutaneous administration of RO7434656 determined using plasma samples collected from Day 1 to Day 90 of the Observation Period 2. Number of participants with adverse events (AEs) and severity of AEs determined according to National Cancer Institute Common Terminology Criteria For Adverse Events (NCI CTCAE), Version 5.0 from Screening to Observation Period (up to approximately 174 days) 3. Number of participants with alanine aminotransferase (ALT) more than 3 * upper limit of normal, assessed using data from electronic case reported forms (eCRF) from Screening to end of Observation Period (up to approximately 174 days) 4. Number of participants with meningococcal and pneumococcal infections, assessed using data from eCRF from Screening to the end of the Observation Period (up to approximately 174 days) 5. Number of participants with injection-site reactions and severity, assessed using data collected in the eCRF from Day 1 to Day 90 | — |
Countries
China
Contacts
Public ContactClinical Trials
Outcome results
None listed