This study will assess the safety and tolerability of RO7049389 compared to placebo in single- and multiple-ascending doses in healthy Chinese participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
31
Huashan Hospital Affiliated to Fudan University
Shanghai, China
Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time frame: From the date of first administered dose through 28 days after the last administered dose.
Maximum Observed Plasma Concentration (Cmax) of RO7049389
Time frame: At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)
Time to Maximum Observed Plasma Concentration (Tmax) of RO7049389
Time frame: At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)
Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration (AUClast) of RO7049389
Time frame: At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)
Area Under the Plasma Concentration vs Time Curve Extrapolated to Infinity (AUC0-inf)
Time frame: At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)
Apparent Half-Life (T1/2) of RO7049389
Time frame: At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)
Clearance (CL/F) of RO7049389
Time frame: At pre-defined intervals on Day 1 (SAD)
Trough Plasma Concentration (Ctrough) of RO7049389
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Time frame: At pre-defined intervals on Day 14 (MAD)
Accumulation Index of RO7049389
Time frame: At pre-defined intervals on Day 14 (MAD)
Area Under the Concentration vs Time Curve for a Dosing Interval (AUCtau)
Time frame: At pre-defined intervals on Day 14 (MAD)