About this trial
The main purpose of this study is to evaluate the safety and tolerability of single and multiple ascending doses of RO7806881 in healthy participants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants must be males or females who are overtly healthy as determined by medical evaluation
Participants must have body weight (BW) ≥ 40 kilograms (kg) (not applicable to Cohort A9) and body mass index (BMI) within the range 18-32 kilograms per square meter (kg/m²) (inclusive)
Must be of ethnic Chinese, Korean, or Japanese origin
Must have a BW >35 kg and BMI within the range 18-32 kg/m2 (inclusive)
Disqualifiers
Pregnancy, breastfeeding, or intention to become pregnant during the study or within 6 months after the final dose of study treatment
History of any clinically significant autoimmune, gastrointestinal, renal, hepatic, pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological, or allergic disease; metabolic disorder; cancer or cirrhosis
Latent tuberculosis (TB) or potentially active TB
Any major illness within 1 month before the screening examination or any febrile illness within 1 week prior to the screening visit and up to first dose administration
Trial design
Parallel
Treatments tested in this trial
RO7806881
DrugRO7806881 will be administered as per the schedule specified in the protocol.
Placebo
DrugPlacebo will be administered as per the schedule specified in the protocol.
Treatment groups
Trial outcomes
Primary outcomes
SAD Part: Number of Participants With Adverse Events (AEs)
MAD Part: Number of Participants With AEs
SAD Part: Number of Participants With Dose-limiting Adverse Events (DLAEs)
MAD Part: Number of Participants With DLAEs
Secondary outcomes
SAD and MAD Parts: Serum Concentration of RO7806881
SAD and MAD Parts: Maximum Concentration (Cmax) of RO7806881
SAD and MAD Parts: Minimum Concentration (Cmin) of RO7806881
SAD and MAD Parts: Area Under the Curve (AUC) From the Last Time of Dosing to the Last Measurable Concentration (AUClast) of RO7806881
Sponsors and contacts
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