A Study of TCD601 (Siplizumab) in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients
ConditionALS
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorITB-Med LLC
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Patient with severe systemic infections, current or within the two weeks prior to randomization.
Subjects who, in the opinion of the investigator, are not capable of giving informed consent for the study or who are unable or unwilling to adhere to the study requirements outlined in the protocol.
Use of other investigational products or treatment in another investigational drug study within 30 days of screening
Pregnant or nursing (lactating) women.
Trial design
Treatments tested in this trial
- TCD601
Treatment groups
48 Participants
are divided into 1 treatment groupLocations
3Skåne University Hospital Malmö205 02, Malmö Sweden
Studieenheten Akademiskt Specialistcentrum171 77, Stockholm Sweden
Umeå University Hospital901 85, Umeå Sweden
Sponsors and collaborators
ITB-Med LLC
Lead sponsor
Source ClinicalTrials.gov