The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RO7507062 in participants with systemic lupus erythematosus (SLE). The study will have 2 parts: Part 1 is a single ascending dose-finding (SAD) part and Part 2 is a dose escalation with fractionated dosing part.
Tocilizumab is an additional investigational medicinal product (IMP), which may be used at the investigator's discretion when required in case of clinical presentation of cytokine release syndrome (CRS).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
RO7507062 solution for injection will be administered SC as specified in each treatment part (arm).
When applicable, tocilizumab solution for infusion will be administered intravenously at 8 milligram per kilogram (mg/kg) for participants \>/= 30 kg or at 12 mg/kg for participants \< 30 kg.
Clinica De La Costa
Barranquilla, Colombia
Hospital Pablo Tobon Uribe
Medellín, Colombia
Part 1: Number of Participants with Dose Limiting Adverse Events (DLAEs)
Time frame: Day 1 through Day 29
Part 2: Fractionated Dose Cohort: Number of Participants with DLAEs
Time frame: Day 1 through to the end of the 28-day safety evaluation period
Number of Participants with Adverse Events (AEs)
Adverse events will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), and CRS, will be graded based on the American Society for Transplantation and Cell Therapy (ASTCT) criteria.
Time frame: Up to approximately 12 months
Serum Concentration of RO7507062
Time frame: Up to approximately 12 months
Time to Maximum Serum Concentration (Tmax) of RO7507062
Time frame: Up to approximately 12 months
Maximum Serum Concentration (Cmax) of RO7507062
Time frame: Up to approximately 12 months
Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7507062
Time frame: Up to approximately 12 months
Area Under the Serum Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUClast) of RO7507062
Time frame: Up to approximately 12 months
Apparent Terminal Half-Life (T1/2) of RO7507062
Time frame: Up to approximately 12 months
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Oncomedica S.A.
Montería, Colombia
Groupe Hospitalier Pitie-Salpetriere
Paris, France
Charité Research Organisation GmbH
Berlin, Germany
Hospital Umum Sarawak
Kuching, Malaysia
CREA Hospital Mexico Americano
Guadalajara, Jalisco, Mexico
Hospital Angeles De Lindavista
Mexico City, Mexico CITY (federal District), Mexico
Hospital General De Mexico
Mexico City, Mexico CITY (federal District), Mexico
Centre For Human Drug Research
Leiden, Netherlands
...and 9 more locations
Terminal Rate Constant (λz) of RO7507062
Time frame: Up to approximately 12 months
Apparent Volume of Distribution (Vz/F) of RO7507062
Time frame: Up to approximately 12 months
Apparent Total Body Clearance (CL/F) of RO7507062
Time frame: Up to approximately 12 months
Number of Participants with Anti-Drug Antibodies (ADAs) to RO7507062
Time frame: Up to approximately 12 months