This study will evaluate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses (SAD) (Part 1a), multiple ascending doses (MAD) (Part 1b), and the food effect (Part 1c) of RO7763505 in healthy adult participant. In Part 2, the safety, tolerability, PK and PD of multiple doses of RO7763505 in participants with stable coronary artery diseases (CAD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
196
ICON Plc (LPRA) - Netherlands
Groningen, Netherlands
Part 1a and Part 1b: Percentage of Participants With Adverse Events (AEs)
Time frame: Part 1a: Approximately up to 2 Weeks; Part 1b: Approximately up to 3 Weeks
Part 1c: Plasma Concentration of RO7763505 in Fasted and fed State
Time frame: Approximately up to 3 Weeks
Part 2: Percentage of Participants With AEs
Time frame: Approximately up to 6 Weeks
Part 1a and Part 1b: Plasma Concentration of RO7763505 and its Metabolites
Time frame: Part 1a: Approximately up to 2 Weeks; Part 1b: Approximately up to 3 Weeks
Part 1a and Part 1b: Percentage Change From Baseline in Inhibition of Ex Vivo-Stimulated Interleukin-1 Beta ( IL-1β)
Time frame: Part 1a: Baseline, Approximately up to 2 Weeks; Part 1b: Baseline, Approximately up to 3 Weeks
Part 1c: Percentage of Participants With AEs
Time frame: Approximately up to 3 Weeks
Part 2: Plasma Concentration of RO7763505 and its Metabolites
Time frame: Approximately up to 6 Weeks
Part 2: Percentage Change From Baseline in Inhibition of Ex Vivo-Stimulated IL-1β
Time frame: Baseline, Approximately up to 6 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.