Pharmaceutical Research Associates (PRA) Health Sciences
NZ Groningen, 9728, Netherlands
NCT Number: NCT03156738
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and immunogenicity of MT-2990 in healthy male subjects.
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Notify Me18 year–55 year
Male
Interventional
Phase 1
NZ Groningen, 9728, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will receive a single IV dose of MT-2990
Subjects will receive a single IV dose of placebo
Time frame: Up to Day 85
Adverse events will be summarised by dose level.
Time frame: Up to Day 85
Vital signs variables and changes from Baseline will be summarised by dose level.
Time frame: Up to Day 85
12-lead ECG variables and changes from Baseline will be summarised by dose level.
Time frame: Up to Day 85
Laboratory variables and changes from Baseline will be summarised by dose level.
Time frame: Up to Day 85
Physical examination data will be listed by subject.
Time frame: Up to Day 85
Cmax will be summarised by dose level.
Time frame: Up to Day 85
tmax will be summarised by dose level.
Time frame: Up to Day 85
t½ will be summarised by dose level.
Time frame: Up to Day 85
AUC0-last will be summarised by dose level.
Time frame: Up to Day 85
AUC0-∞ will be summarised by dose level.
Time frame: Up to Day 85
Kel will be summarised by dose level.
Time frame: Up to Day 85
Vss will be summarised by dose level.
Time frame: Up to Day 85
Vz will be summarised by dose level.
Time frame: Up to Day 85
MRT0-∞ will be summarised by dose level.
Time frame: Up to Day 85
CL will be summarised by dose level.
Time frame: Up to Day 85
%AUCex will be summarised by dose level.
Time frame: Up to Day 85
The proportion of subjects who develop antibodies against MT 2990 in serum will be summarised using descriptive statistics on the Safety Analysis Set.
Tanabe Pharma Corporation
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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