NCT05704361

A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis

A Multiple-center, Non-randomized, Open-label, Adaptive, Single-ascending Dose (Part 1 and Part 2) and Multiple-ascending Dose (Part 3) Parallel, Phase IB Study to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of RO7121932 Following Intravenous (Parts 1) and Subcutaneous Administration (Parts 2 and 3) in Participants With Multiple Sclerosis

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 129 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the study is to evaluate the safety and tolerability of a single-ascending intravenous (IV) dose (Part 1), a single-ascending subcutaneous (SC) dose (Part 2), and multiple ascending SC doses (Part 3) of RO7121932 in participants with multiple sclerosis (MS).

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	RO7121932 IV	Participants will receive RO7121932, as an IV infusion, per the schedule specified in the treatment arms.
DRUG	RO7121932 SC	Participants will receive RO7121932, as SC injection, per the schedule specified in the treatment arms.

Timeline

• Start date: 2021-08-11
• Primary completion: 2027-07-08
• Completion: 2027-07-08
• First posted: 2023-01-30
• Last updated: 2026-03-30

Locations

32 sites across 12 countries: United States, Belgium, Canada, Germany, Israel, Italy, Moldova, Poland, Portugal, Romania, Serbia, Spain

Regulatory

• FDA-regulated drug study