Neurological disorders
Conditions
Interventions
Five (5) single ascending doses of NX210 are planned to be tested in 5 cohorts
of 8 healthy subjects each. In each cohort, subjects will be randomized in a
3:1 fashion to NX210 or placebo.
Sponsors
Axoltis Pharma
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subject is a male or is a female of non-childbearing potential, aged between 18 and 55 years (inclusive). A body weight of >=50.0 kg and =18.0 kg/m2 and
Exclusion criteria
Exclusion criteria: Prior or ongoing medical condition, medical history, physical findings, ECG findings, laboratory or vital signs abnormality that, in the Investigator's opinion, could adversely affect the safety of the subject. The subject has a current or recurrent disease (e.g., cardiovascular,renal, liver, gastrointestinal, malignancy or other conditions) that could affect the distribution, metabolism or excretion of the investigational product or could affect clinical or laboratory assessments. History of any clinically significant allergy, hypersensitivity or intolerance. Subject with one or more of the following laboratory abnormalities at Screening and between Screening and dosing: abnormal Alanine aminotransferase (AST), abnormal aspartate aminotransferase (ALT) or abnormal alkaline phosphatase levels (ALP) >=1.5 x upper limit of normal (ULN); total bilirubin >=1.5 x ULN; or clinically significant laboratory abnormalities or abnormalities which are deemed to interfere with the ability to interpret study data. A repeat is allowed once to determine eligibility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following are defined as safety/tolerability parameters: Physical examination; (Serious) adverse events (SAEs and AEs); Clinical laboratory assessments including hematology, biochemistry and urinalysis; 12-lead ECG; Telemetry; Vital signs; Local tolerability. The following are defined as PK plasma parameters for NX210 via its metabolite NX210c (calculated using a non-compartmental model): Maximum concentration (Cmax); Time to Cmax (tmax); Terminal elimination rate constant (Kel); Terminal elimination half-life (t1/2); Area under the concentration-time curve (AUC) from time of dosing (zero) to time t of the last measured concentration above the limit of quantification (AUC0-t); AUC under the concentration-time curve from time zero to infinity (AUC0-inf); Total clearance (CL); Volume of distribution (Vz). | — |
Secondary
| Measure | Time frame |
|---|---|
| Nap | — |
Countries
Netherlands
Outcome results
None listed