A Study of TCD601 (Siplizumab) in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients
Recruiting
Phase 1
Interventional Study
ALS
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Basic Science
- Participants needed
- 48 (estimated)
- Sponsor
- ITB-Med LLC · Industry
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About This Trial
The purpose of this study is to investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of TCD601 (siplizumab) in newly diagnosed adult ALS patients.
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
* Male or female patients ≥ 18 to 80 years of age.
* Diagnosis of ALS by revised El Escorial Criteria, at study entry within 24 months of first symptoms.
* Patients on existing ALS treatment must have been on a stable dose for 28 days.
Key Exclusion Criteria:
* Patient wit…
Contacts