Healthy
Conditions
Brief summary
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and immunogenicity of MT-2990 in healthy male subjects.
Interventions
DRUGMT-2990
Subjects will receive a single IV dose of MT-2990
DRUGPlacebo
Subjects will receive a single IV dose of placebo
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects are able and willing to provide written informed consent to participate in this study * Healthy male subjects aged 18 to 55 years (inclusive) * Free from clinically significant (CS) illness or disease * Body weight of 60 to 100 kg (inclusive) * Body mass index (Quetelet index) ranging from 18 to 30 kg/m2 (inclusive).
Exclusion criteria
* A CS endocrine, thyroid, hepatic, respiratory, gastrointestinal, neurological (including history of seizures), renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness or disorder (including anxiety, depression and reactive depression) * Presence or history of any known malignancy with the exception of basal cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the Screening Visit * A history of bacterial or viral infections that led to hospitalisation and IV antibiotic or antiviral treatment within 3 months prior to Screening, or any recent infection requiring antibiotic or antiviral treatment within 4 weeks of Day -1 * A history of recurrent or chronic sinusitis, bronchitis, pneumonia, urinary tract infection (recurrent or chronic infection is two episodes within 6 months) * A history of tuberculosis (TB) or malaria; history or any evidence of active infection or febrile illness within 7 days of dosing (e.g., bronchopulmonary, urinary, or gastrointestinal) * An active, or history of, parasitic infections; any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the subject's immune status (e.g., history of splenectomy) * Presence or history of severe adverse reaction or allergy to any drug or allergy that is of clinical significance to the Investigational Medicinal Product (IMP) * A positive test result for QuantiFERON-TB Gold® Plus, hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus (HIV)-1 or HIV-2 antibodies at Screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability as measured by incidence, nature and severity of adverse events | Up to Day 85 | Adverse events will be summarised by dose level. |
| Safety and tolerability as measured by vital signs | Up to Day 85 | Vital signs variables and changes from Baseline will be summarised by dose level. |
| Safety and tolerability as measured by ECG parameters | Up to Day 85 | 12-lead ECG variables and changes from Baseline will be summarised by dose level. |
| Safety and tolerability as measured by clinical laboratory assessments | Up to Day 85 | Laboratory variables and changes from Baseline will be summarised by dose level. |
| Safety and tolerability as measured by physical examination | Up to Day 85 | Physical examination data will be listed by subject. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Terminal elimination rate constant (Kel) of MT-2990 | Up to Day 85 | Kel will be summarised by dose level. |
| Apparent volume of distribution at steady state (Vss) of MT-2990 | Up to Day 85 | Vss will be summarised by dose level. |
| Apparent volume of distribution during terminal phase after IV administration (Vz) of MT-2990 | Up to Day 85 | Vz will be summarised by dose level. |
| Maximum observed serum concentration (Cmax) of MT-2990 | Up to Day 85 | Cmax will be summarised by dose level. |
| Apparent serum clearance (CL) of MT-2990 | Up to Day 85 | CL will be summarised by dose level. |
| Percentage of AUC obtained by extrapolation (%AUCex) of MT-2990 | Up to Day 85 | %AUCex will be summarised by dose level. |
| Proportion of subjects who develop antibodies against MT-2990 in serum | 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. |
| Mean residence time from time zero to infinity (MRT0-∞) of MT-2990 | Up to Day 85 | MRT0-∞ will be summarised by dose level. |
| Measured time of maximum observed serum concentration (tmax) of MT-2990 | Up to Day 85 | tmax will be summarised by dose level. |
| Apparent terminal elimination half-life (t1/2) of MT-2990 | Up to Day 85 | t½ will be summarised by dose level. |
| AUC from time zero to the last measurable concentration (AUC0-last) of MT-2990 | Up to Day 85 | AUC0-last will be summarised by dose level. |
| AUC from time zero to infinity (AUC0-∞) of MT-2990 | Up to Day 85 | AUC0-∞ will be summarised by dose level. |
Countries
Netherlands
Outcome results
None listed