Healthy volunteers Not Applicable
Conditions
Interventions
RO7223280: Participants in each cohort will receive a single dose of RO7223280 or a matching placebo, as an IV infusion, on Day 1 of the dosing period. The planned dose-escalation sequence is 600 mill
Sponsors
F Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants aged 18 to 64 years inclusive at screening 2. Healthy Chinese males and females (women of non-childbearing potential [WONCBP]) participants 3. Body weight of at least 50 kilograms (kg) and body mass index (BMI) within the range of 18 to 32 kilograms per square meter (kg/m2) (inclusive)
Exclusion criteria
Exclusion criteria: 1. History or evidence of any medical condition potentially altering the absorption, metabolism, or elimination of drugs 2. History of malignancy 3. Vaccination is prohibited within two months prior to Day 1 4. Use of glucocorticoids and other immunosuppressive medications is prohibited within 30 days (or within five times the elimination half-life, whichever is longer), prior to Day 1 5. Participation in an investigational drug medicinal product or medical device study within 30 days prior to screening or within five times the elimination half-life if known, whichever is longer 6. Clinically significant abnormalities (as judged by the Investigator) in laboratory test results 7. Positive results on human immunodeficiency virus (HIV)-1, HIV-2, hepatitis B virus, or hepatitis C virus (HCV) tests (including hepatitis B surface antigen, HCV antibody, and HIV antigen/antibody tests at screening)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Time to maximum plasma concentration (Tmax) of RO7223280 calculated using standard non-compartmental methods of analysis at pre-dose and multiple time-points post-dose from Day 1 up to Day 5 2. Maximum observed serum concentration (Cmax) of RO7223280 calculated using standard non-compartmental methods of analysis at pre-dose and multiple time-points post-dose from Day 1 up to Day 5 3. Time to the last measurable time point (Tlast) of RO7223280 calculated using standard non-compartmental methods of analysis at pre-dose and multiple time-points post-dose from Day 1 up to Day 5 4. Observed last measurable plasma concentration (Clast) of RO7223280 calculated using standard non-compartmental methods of analysis at pre-dose and multiple time-points post-dose from Day 1 up to Day 5 5. Area under the plasma concentration versus time curve from zero to the last measurable concentration (AUClast) of RO7223280 calculated using standard non-compartmental methods of analysis at pre-dose and multiple time-points post-dose from Day 1 up to Day 5 6. Area under the plasma concentration versus time curve from zero to 72 hours (AUC0-72) of RO7223280 calculated using standard non-compartmental methods of analysis at pre-dose and multiple time-points post-dose from Day 1 up to Day 5 7. Area under the plasma concentration versus time curve extrapolated to Infinity (AUCinf) of RO7223280 calculated using standard non-compartmental methods of analysis at pre-dose and multiple time-points post-dose from Day 1 up to Day 5 8. Terminal rate constant (?z) of RO7223280 calculated using standard non-compartmental methods of analysis at pre-dose and multiple time-points post-dose from Day 1 up to Day 5 9. Apparent terminal half-life (T1/2) of RO7223280 Calculated Using Standard Non-compartmental Methods of Analysis at Pre-dose and Multiple Time-points Post-dose from Day | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
China
Contacts
Public ContactClinical Trials
Outcome results
None listed