Trial intelligence / Profile preview

Safety and PK of Fenebrutinib in Healthy Japanese and Caucasian Subjects

NCT03188783Phase 1Completed

Sponsor
Roche
Start
Jan 2017
Primary completion
Aug 2017
Modality
Small Molecules
Countries
1
01

Overview

Phase 1, randomised, double-blind trial of fenebrutinib in multiple sclerosis (MS), rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) and 1 more (4 cohorts), sponsored by Roche. Primary endpoints: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) at Day 36 and Number of Participants with Clinical Significant Change in Vital Sign, Physical Examination Findings, Clinical Laboratory Results and Electrocardiograms (ECGs) at Day 36. Started Jan 2017; status: completed.

02

Drugs

fenebrutinib
03

Conditions

multiple sclerosis (MS)rheumatoid arthritis (RA)systemic lupus erythematosus (SLE)chronic spontaneous urticaria (CSU)

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