Multiple Sclerosis relapsing-remitting MS
Conditions
Interventions
T20K or placebo, single dose.
Sponsors
Cyxone AB
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male subject between 18 and 55 years, inclusive, at the time of screening. 2. Healthy as determined by the Investigator, based upon a medical evaluation including medical history, physical examination and clinical laboratory testing performed at Screening. 3. A body weight of *60 kg and a body mass index (BMI) *18.0 kg/m2 and * 30.0 kg/m2 at Screening.
Exclusion criteria
Exclusion criteria: 1. Evidence of active and/or chronic disease that, in the Investigator*s opinion, could interfere with the study procedures or could adversely affect the safety of the subject or could affect the safety and/or pharmacokinetic (PK) evaluations. 2. History of drug abuse. 3. Positive urine drug screen and/or positive alcohol breath test at Screening or on Day -1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability parameters including adverse events (AEs), vital signs, physical examination, 12-lead ECG, telemetry, local tolerance and clinical laboratory values after single ascending dose administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentrations of T20K. | — |
Countries
Netherlands
Outcome results
None listed