A Clinical Study to Investigate How Safe and Tolerable the Study Drug MT-2990 is and How MT-2990 is Taken up by the Body in Healthy Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and immunogenicity of MT-2990 in healthy male subjects.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: MT-2990
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1<br>MT-2990 or Placebo | Drug: MT-2990<br>* Subjects will receive a single IV dose of MT-2990<br>Drug: Placebo<br>* Subjects will receive a single IV dose of placebo<br>|
| Experimental: Dose 2<br>MT-2990 or Placebo | Drug: MT-2990<br>* Subjects will receive a single IV dose of MT-2990<br>Drug: Placebo<br>* Subjects will receive a single IV dose of placebo<br>|
| Experimental: Dose 3<br>MT-2990 or Placebo | Drug: MT-2990<br>* Subjects will receive a single IV dose of MT-2990<br>Drug: Placebo<br>* Subjects will receive a single IV dose of placebo<br>|
| Experimental: Dose 4<br>MT-2990 or Placebo | Drug: MT-2990<br>* Subjects will receive a single IV dose of MT-2990<br>Drug: Placebo<br>* Subjects will receive a single IV dose of placebo<br>|
| Experimental: Dose 5<br>MT-2990 or Placebo | Drug: MT-2990<br>* Subjects will receive a single IV dose of MT-2990<br>Drug: Placebo<br>* Subjects will receive a single IV dose of placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as measured by incidence, nature and severity of adverse events | Adverse events will be summarised by dose level. | Up to Day 85 | 
| Safety and tolerability as measured by vital signs | Vital signs variables and changes from Baseline will be summarised by dose level. | Up to Day 85 | 
| Safety and tolerability as measured by ECG parameters | 12-lead ECG variables and changes from Baseline will be summarised by dose level. | Up to Day 85 | 
| Safety and tolerability as measured by clinical laboratory assessments | Laboratory variables and changes from Baseline will be summarised by dose level. | Up to Day 85 | 
| Safety and tolerability as measured by physical examination | Physical examination data will be listed by subject. | Up to Day 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed serum concentration (Cmax) of MT-2990 | Cmax will be summarised by dose level. | Up to Day 85 | 
| Measured time of maximum observed serum concentration (tmax) of MT-2990 | tmax will be summarised by dose level. | Up to Day 85 | 
| Apparent terminal elimination half-life (t1/2) of MT-2990 | t½ will be summarised by dose level. | Up to Day 85 | 
| AUC from time zero to the last measurable concentration (AUC0-last) of MT-2990 | AUC0-last will be summarised by dose level. | Up to Day 85 | 
| AUC from time zero to infinity (AUC0-∞) of MT-2990 | AUC0-∞ will be summarised by dose level. | Up to Day 85 | 
| Terminal elimination rate constant (Kel) of MT-2990 | Kel will be summarised by dose level. | Up to Day 85 | 
| Apparent volume of distribution at steady state (Vss) of MT-2990 | Vss will be summarised by dose level. | Up to Day 85 | 
| Apparent volume of distribution during terminal phase after IV administration (Vz) of MT-2990 | Vz will be summarised by dose level. | Up to Day 85 | 
| Mean residence time from time zero to infinity (MRT0-∞) of MT-2990 | MRT0-∞ will be summarised by dose level. | Up to Day 85 | 
| Apparent serum clearance (CL) of MT-2990 | CL will be summarised by dose level. | Up to Day 85 | 
| Percentage of AUC obtained by extrapolation (%AUCex) of MT-2990 | %AUCex will be summarised by dose level. | Up to Day 85 | 
| Proportion of subjects who develop antibodies against MT-2990 in serum | The proportion of subjects who develop antibodies against MT 2990 in serum will be summarised using descriptive statistics on the Safety Analysis Set. | Up to Day 85 |