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RO7507062 · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Part 1: SAD: RO7507062 | EXPERIMENTAL | Participants will receive RO7507062 at an assigned dose as subcutaneous (SC) injection on Day 1. |
| Part 2: Dose Escalation with Fractionated Dosing: RO7507062 | EXPERIMENTAL | Participants will receive RO7507062 as SC injection at the dose determined in Part 1, on Day 1 and as escalated doses on subsequent days. |
| Name | Type | Description |
|---|---|---|
| RO7507062 | DRUG | RO7507062 solution for injection will be administered SC as specified in each treatment part (arm). |
| Tocilizumab | DRUG | 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. |
Inclusion Criteria: * Participants must have a diagnosis of SLE according to the 2019 European League Against Rheumatism (EULAR) or American College of Rheumatology (ACR) Classification Criteria at least 24 weeks prior to Screening and should have been treated for SLE according to standard clinical...
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RO7507062 is an investigational small molecule being developed for the treatment of Systemic Lupus Erythematosus (SLE). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in a first-in-human trial to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in participants with SLE.
RO7507062 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting a Phase 1 clinical trial of this investigational small molecule for Systemic Lupus Erythematosus. Roche is responsible for the drug's development and clinical testing program.
RO7507062 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or any other regulatory agency. The drug is being studied in a first-in-human trial for Systemic Lupus Erythematosus, and its safety and tolerability are currently being evaluated in this early-stage study.
RO7507062 is being studied in one active Phase 1 clinical trial with the identifier NCT05835986. This first-in-human study is investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7507062 in participants with Systemic Lupus Erythematosus. The trial is currently active but not recruiting participants and has a planned enrollment of 70 patients.
RO7507062 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Systemic Lupus Erythematosus. The drug is being evaluated in a first-in-human study to assess its safety, tolerability, pharmacokinetics, and pharmacodynamics. Regulatory approval has not been granted, and the drug remains under clinical investigation.