A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis
Phase 1
129
about 5.9 years
18–65
5 sites in CA, CT, FL +2
What this study is about
Researchers are testing a treatment called RO7121932. The trial will be given intravenously (IV) or subcutaneously (SC). The goal is to see if it's safe and how the body processes this treatment in people with multiple sclerosis.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Receive RO7121932 IV
- 2.Take RO7121932 SC
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
infusion, subcutaneous
Primary: Parts 1, 2, and 3: Change From Baseline in Suicide Risk as Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS), Parts 1, 2, and 3: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) With Severity of AEs Measured According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5 (NCI CTCAE V5), Parts 2 and 3: Percentage of Participants With Local Injection-site Reaction Using Local Injection-site Symptom Assessment (LISSA), Parts 2 and 3: Percentage of Participants With Local Pain at the Site of Injection Assessed Using the Visual Analog Scale (VAS)
Secondary: Part 1: Total Body Clearance (CL) Of RO7121932, Parts 1 and 2: AUC From Time 0 to Infinity (AUCinf), Parts 1 and 3: Change From Baseline in B-cell Frequencies in CSF, Parts 1, 2 and 3 (Week 1 and Week 4): Maximum Observed Serum Concentration (Cmax) of RO7121932, Parts 1, 2 and 3 (Week 1 and Week 4): Time to Maximum Observed Concentration (Tmax) of RO7121932, Parts 1, 2 and 3: Apparent Terminal Half-Life (T1/2) of RO7121932, Parts 1, 2, and 3: Change From Baseline in B-cell Frequencies in Blood, Parts 2 and 3 (Week 4): Apparent Clearance (CL/F) of RO7121932
Neurology