A randomised, double-blind, placebo-controlled, study to investigate the safety, tolerability and pharmacokinetics of single ascending doses of MT-2990 in healthy male subjects.

Completed

Conditions: ontstekingsziektes.
inflammation

Registration Number: NL-OMON45915

Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 48

Inclusion Criteria

healthy male subjects
18 - 55 years of age, inclusive
BMI 18 - 30 kilograms/meter2, inclusive
weight 60 - 100 kilograms, inclusive

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary assessments:<br /><br>Incidence, nature and severity of adverse events (AEs)<br /><br>Vital signs (blood pressure, pulse rate and tympanic body temperature)<br /><br>ECG parameters (including HR and cardiac intervals: PR, QRS, QT and corrected<br /><br>QT interval using Fridericia*s formula [QTcF])<br /><br>Clinical laboratory assessments (haematology, biochemistry, coagulation and<br /><br>urinalysis)<br /><br>Physical examination.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary assessments:<br /><br>PK assessments<br /><br>PK concentrations vs. time profile of MT-2990.<br /><br>The following PK parameters of MT 2990 will be calculated after single dosing:<br /><br>Cmax<br /><br>Time to Cmax (tmax)<br /><br>t<br /><br>AUC0-last<br /><br>AUC0-<br /><br>Terminal elimination rate constant (Kel)<br /><br>Apparent volume of distribution at steady state (Vss)<br /><br>Apparent volume of distribution during the terminal phase after IV<br /><br>administration (Vz)<br /><br>Mean residence time from time zero to infinity (MRT0-*)<br /><br>Apparent serum clearance (CL)<br /><br>Percentage of AUC obtained by extrapolation (%AUCex).<br /><br><br /><br>Immunogenicity<br /><br>Proportion of subjects who develop antibodies against MT-2990 in serum.</p><br>