RecruitingPhase 1NCT06453668

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

A 52-week, Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Trial of Siplizumab in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients (AURORA)

Sponsor

ITB-Med LLC

Enrollment

48 participants

Start Date

Apr 16, 2024

Study Type

INTERVENTIONAL

Conditions

ALS

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called TCD601 for people with als. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTCD601

Investigational Product

Locations(3)

Skåne University Hospital Malmö

Malmö, Sweden

Studieenheten Akademiskt Specialistcentrum

Stockholm, Sweden

Umeå University Hospital

Umeå, Sweden

View Full Details on ClinicalTrials.gov

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NCT06453668

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