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RECRUITING
NCT06453668
PHASE1

A Study of TCD601 (Siplizumab) in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients

Sponsor: ITB-Med LLC

View on ClinicalTrials.gov

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

BIOLOGICAL

TCD601

Investigational Product

Locations (3)

Skåne University Hospital Malmö

Malmo, Sweden

Studieenheten Akademiskt Specialistcentrum

Stockholm, Sweden

Umeå University Hospital

Umeå, Sweden