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A Study of TCD601 (Siplizumab) in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients
Sponsor: ITB-Med LLC
Summary
The purpose of this study is to investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of TCD601 (siplizumab) in newly diagnosed adult ALS patients.
Official title: A 52-week, Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Trial of Siplizumab in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients (AURORA)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2024-04-16
Completion Date
2029-11
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
TCD601
Investigational Product
Locations (3)
Skåne University Hospital Malmö
Malmo, Sweden
Studieenheten Akademiskt Specialistcentrum
Stockholm, Sweden
Umeå University Hospital
Umeå, Sweden