Healthy participants Not Applicable
Conditions
Interventions
1. Stage 1 Sequence 1: Participants will first receive a single dose of 1st generation RO7490677, 10 milligrams per kilogram (mg/kg), intravenous (IV) infusion, on Day 1. After a washout period of 7 d
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 70 years, both inclusive 2. Within body mass index (BMI) range 18.0 to 36.0 kilogram per square metre (kg/m²), both inclusive 3. Negative hepatitis panel (hepatitis B surface antigen, hepatitis B virus core antibody total, and hepatitis C virus antibody) and negative human immunodeficiency virus (HIV) p24 antigen/antibody screens 4. Negative screening test for active or latent Mycobacterium tuberculosis (TB) infection by QuantiFERON® TB Gold Plus Other protocol-specified inclusion criteria may apply.
Exclusion criteria
Exclusion criteria: 1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, immunological, neurological, or psychiatric disorder; acute infection; or other unstable medical disease, as determined by the investigator 2. History of moderate or severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins 3. History or presence of any malignancy, except for completely excised basal cell or squamous cell carcinoma of the skin 4. History or presence of a clinically significant ECG abnormality, as determined by the investigator, or known history of family history of a prolonged QT interval syndrome 5. History or presence of atrial fibrillation 6. History of uncontrolled hypertension, hyperlipidemia, thyroid disorder, or diabetes, as determined by the investigator 7. History of active or latent TB, regardless of treatment history 8. Use of oral antibiotics within 4 weeks or IV antibiotics within 8 weeks prior to Screening 9. Administration of a vaccine (including seasonal flu, H1N1, and Coronavirus Disease 2019 [COVID-19] vaccine) in the past 30 days prior to dosing 10. Evidence of current/positive test result for severe acute respiratory syndrome coronavirus 2 (i.e., the virus that causes COVID-19) infection at Screening or Check-in 11. Donation of blood within 30 days prior to Screening through study completion, inclusive, or of plasma within 2 weeks prior to Screening through study completion, both inclusive 12. Receipt of blood products within 2 months prior to Check-in 13. Female participants who are pregnant, lactating, or breastfeeding. Other protocol-specified exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Maximum plasma concentration (Cmax) of RO7490677 Measured Using Plasma Samples at Multiple Timepoints from Day 1 to Day 15 2. Area Under the Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of RO7490677 Measured Using Plasma Samples at Multiple Timepoints from Day 1 to Day 15 3. Area Under the Concentration-Time Curve extrapolated to Infinity (AUC0-8) of RO7490677 Measured Using Plasma Samples at Multiple Timepoints from Day 1 to Day 15 4. Percentage of Participants with Adverse Events (AEs) Measured from Screening to 28 days after last dose of study drug (approximately Day 36) 5. Percentage of Participants with Clinically Significant Laboratory Findings Measured Using Blood and Urine Samples from Screening, up to Day 15 6. Percentage of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters Measured Using Single 12-Lead ECG from Screening, up to Day 15 7. Percentage of Participants with Clinically Significant Changes in Vital Sign Values Measured Using Oral Temperature, Respiratory Rate, and Supine Blood Pressure and Pulse Measured from Screening up to Day 15 8. Percentage of Participants with Clinically Significant Changes in Physical Examinations Measured by Assessment of general appearance; skin; thorax/lungs; abdomen; lymph nodes; head; ears; eyes; nose, throat; neck (including thyroid); and cardiovascular, musculoskeletal, and neurological systems Performed at Screening, and on other timepoints at the investigator’s discretion up to Day 15 9. Percentage of Participants with Anti-drug Antibodies (ADAs) Measured Using Serum Samples from Baseline up to Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to Achieve Cmax (Tmax) of RO7490677 Measured Using Plasma Samples at Multiple Timepoints from Day 1 to Day 15 2. AUC from Hour 0 to 168 hours Post-Dose (AUC0-168h) of RO7490677 Measured Using Plasma Samples at Multiple Timepoints from Day 1 to Day 15 3. Percentage of AUC that is due to Extrapolation from the Last Measurable Concentration to Infinity (%AUCextrap) of RO7490677 Measured Using Plasma Samples at Multiple Timepoints from Day 1 to Day 15 4. Terminal Elimination Half-Life (t1/2) of RO7490677 Measured Using Plasma Samples at Multiple Timepoints from Day 1 to Day 15 5. Terminal Elimination Rate Constant (?z) of RO7490677 Measured Using Plasma Samples at Multiple Timepoints from Day 1 to Day 15 6. Systemic Clearance (CL) of RO7490677 Measured Using Plasma Samples at Multiple Timepoints from Day 1 to Day 15 7. Volume of Distribution during the Terminal Phase (Vz) of RO7490677 Measured Using Plasma Samples at Multiple Timepoints from Day 1 to Day 15 8. Volume of Distribution at Steady State (Vss) of RO7490677 Measured Using Plasma Samples at Multiple Timepoints from Day 1 to Day 15 | — |
Countries
United States of America
Contacts
Public ContactAbiodun Adefurin
Outcome results
None listed