AI CuratorAI-generated
Research summary · AI summary · not yet reviewedHuman studyPhase 1Trial registry
Phase 1 Study of RO7845860 in Human Subjects with Relapsing Multiple Sclerosis
This Phase 1 study is designed to evaluate the safety, tolerability, and pharmacokinetics of RO7845860 in individuals diagnosed with relapsing multiple sclerosis (RMS), with planned enrollment of about 85 participants over approximately 96 weeks.
- Tags
- #MSResearch
- Most relevant to
- —
- Source
- Read original source
This plain-English summary was written by AI from a published abstract and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.
Why it matters
Understanding the safety and pharmacokinetics of RO7845860 is essential for future MS treatments, as safety is critical to any potential therapy's development.
What this does not prove
No results are available yet, and the planned enrollment and endpoints remain unverified findings.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Not reported
- Participants / samples
- 85 · Estimated
- Randomised
- No
- Controlled
- Not reported
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- No
- Research areas
- Not classified
Original sources
Supporting passages (11)
study phasePHASE1
subjects"eligibilityCriteria": "Inclusion Criteria:\n\n* Diagnosis of RMS (i.e., relapsing-remitting multiple sclerosis \\[RRMS\\] or a secondary progressive multiple sclerosis \\[SPMS\\] where patients still experience relapses) in accordance with the revised 2017 McDonald Criteria.\n* No relapse for 30 days prior to screening and neurologically stable with no relapse during screening.\n* Expanded Disability Status Scale (EDSS) score at screening (historical EDSS not older than 6 months may be used), from 0 to 6.5 inclusive.\n* From Part 2 onwards,\n\n 1.
sample size"count": 85
sample size basis"type": "ESTIMATED"
randomized"allocation": "NON_RANDOMIZED"
regulatory approval"isFdaRegulatedDrug": false
intervention"name": "RO7845860"
primary endpoint"measure": "Part 1, 2 and 3: Incidence and Severity of Adverse Events (AEs)"
follow up"timeFrame": "From Baseline up to approximately Week 96"
findings"The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and, pharmacodynamics (PD) of subcutaneously administered RO7845860 in participants with relapsing multiple sclerosis (RMS)."
limitationsPlanned enrolment and endpoints are not findings.
AI assessment, not yet reviewed by a person · version 1 · Community votes are separate from evidence review.