Amyotrophic Lateral Sclerosis
Conditions
Brief summary
Incidence and severity of AEs, TEAEs and SAEs, Clinical laboratory tests (serum chemistry and hematology; urinalysis), ECGs, Vital signs (blood pressure, heart rate, respiratory rate, body temperature), Physical and neurological exams.
Detailed description
CSF levels of LTX-002, Single-dose plasma PK parameters for the first and last of the three doses, including Cmax, Tmax, AUC0-t, AUC0-∞, Tlag if applicable, Vd/F, λz, T1/2, and CL/F, Where data are available, AUC0-∞ AUC0 t, and Cmax will be tested for dose proportionality using a power model approach.
Interventions
DRUGLTX-002
DRUGPlacebo is identical to IMP but with no active substance. The placebo consists of a corresponding volume of sterile aCSF solution formulation intended for IT administration.
Sponsors
Leal Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of AEs, TEAEs and SAEs, Clinical laboratory tests (serum chemistry and hematology; urinalysis), ECGs, Vital signs (blood pressure, heart rate, respiratory rate, body temperature), Physical and neurological exams. | — |
Secondary
| Measure | Time frame |
|---|---|
| CSF levels of LTX-002, Single-dose plasma PK parameters for the first and last of the three doses, including Cmax, Tmax, AUC0-t, AUC0-∞, Tlag if applicable, Vd/F, λz, T1/2, and CL/F, Where data are available, AUC0-∞ AUC0 t, and Cmax will be tested for dose proportionality using a power model approach. | — |
Countries
Germany
Outcome results
None listed