Phase I, Single-Center, Randomized, Placebo-Controlled, Double-Blinded Study with Single Ascending Doses, Evaluating the Safety and Tolerability of T20K, Administered by a 1-hr IV Infusion in Healthy Male Volunteers
Completed
- Conditions
- 10012303Multiple Sclerosisrelapsing-remitting MS
- Registration Number
- NL-OMON48273
- Lead Sponsor
- Cyxone AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety and tolerability parameters including adverse events (AEs), vital signs,<br /><br>physical examination, 12-lead ECG, telemetry, local tolerance and clinical<br /><br>laboratory values after single ascending dose administration.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Plasma concentrations of T20K.</p><br>