A study to evaluate the safety, tolerability, and processing by the body of single-ascending doses of RO7490677 in healthy participants

INTERVENTION: RO7490677: Participants will receive zinpentraxin alfa (RO7490677) as single intravenous (IV) infusion on Day 1 delivered over 70‐80 min. Dose escalation in additional cohorts, if required, will be made based on available safety data, and when applicable, PK, and anti‐drug antibody (ADA) data from the previous cohorts. Placebo: Participants will receive zinpentraxin alfa matching placebo as single IV infusion on Day 1 delivered over 70‐80 min. In each cohort, a sentinel group of 2 participants will be randomized in a 1:1 ratio and dosed first with study drug: 1 participant with RO7490677 and the other with placebo. The remaining participants in the same cohort will be randomized in a 5:1 ratio to receive RO7490677 or placebo. The study site will obtain the participant s identification number and treatment assignment from a randomization list provided by a contract research organization (CRO) biostatistician. CONDITION: Fibrostenotic Crohn’s disease (FCD) ; Digestive System ; Inflammatory bowel disease (IBD), Crohn’s disease PRIMARY OUTCOME: 1. Safety measured using the incidence of Adverse Events (AEs) between screening and the end of study treatment, or early discontinuation (approximately up to 64 days); 2. Safety measured using the severity of AEs per National Cancer Institute‐Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) grading scale between screening and the end of study treatment, or early discontinuation (approximately up to 64 days); 3. Number of participants with a clinically significant change from baseline in vital signs measured using respiratory rate, pulse rate, systolic and diastolic blood pressure, and temperature at screening, check‐in (Day ‐1), and at multiple timepoints until the end of study treatment, or early discontinuation (approximately up to 64 days); 4. Number of participants with a clinically significant change from baseline in clinical laboratory tests assessed using blood and urine samples collected at screening, check‐in (Day ‐1), and at multiple timepoints until the end of study treatment, or early discontinuation (approximately up to 64 days); 5. Number of participants with a clinically significant change from baseline in 12‐Lead ECG parameters at screening, check‐in (Day ‐1), and at multiple timepoints until the end of study treatment, or early discontinuation (approximately up to 64 days) SECONDARY OUTCOME: 1. Plasma concentration of RO7490677 measured using plasma samples collected at predose and at multiple timepoints post‐dose until the end of study treatment, or early discontinuation (approximately up to Day 29); 2. Area under the concentration‐time curve (AUC) of RO7490677 measured using plasma samples collected at predose and at multiple timepoints post‐dose until the end of study treatment, or early discontinuation (approximately up to Day 29); 3. Maximum observed concentration (Cmax) of RO7490677 measured using plasma samples collected at predose and at multiple timepoints post‐dose until the end of study treatment, or early discontinuation (approximately up to Day 29); 4. Total clearance (CL) of RO7490677 measured using plasma samples collected at predose and at multiple timepoints post‐dose until the end of study treatment, or early discontinuation (approximately up to Day 29); 5. Volume of distribution of RO7490677 measured using plasma samples collected at predose and at multiple timepoints post‐dose until the end of study treatment, or early discontinuation (approximately up to Day 29); 6. Terminal drug‐elimination half‐life (t1/2) of RO7490677 measured using plasma samples collected at predose and at multiple timepoints post‐dose until the end of study treatment, or early discontinuation (approximately up to Day 29); 7. Number of participants with anti‐drug antibodies (ADA) to RO7490677 measured using plasma samples collected at predose and at multiple timepoints post‐dose until the end of study treatment, or early discontinuation (approximately up to Day 29) INCLUSION CRITERIA: 1. Aged =18 and =65 years at the time of signing the Informed Consent Form (ICF) 2. Body mass inde X(BMI) =18 and =32 kg/m² at screening 3. Weight =45 and =100 kg at screening 4. Clinical laboratory evaluations (not including lymphocyte subsets) at screening and on Day ‐1 within the reference range for the test laboratory unless deemed not clinically significant by the investigator 5. Ability to restrict alcohol intake (=2 servings of alcohol per day, where: one serving is 12 ounces of beer, 5 ounces of wine, 1.5 ounces of spirits, or equivalent), to refrain from the use of tobacco or nicotine products (smoking/vaping), and to refrain from illicit drug use during the study 6. For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception 7. For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom and agree to refrain fr