Clinical trial NCT03156738: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2017-05-17
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


Eligibility criteria: 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.

Primary outcomes:
measure: Safety and tolerability as measured by incidence, nature and severity of adverse events
timeFrame: Up to Day 85
measure: Safety and tolerability as measured by vital signs
timeFrame: Up to Day 85
measure: Safety and tolerability as measured by ECG parameters
timeFrame: Up to Day 85
measure: Safety and tolerability as measured by clinical laboratory assessments
timeFrame: Up to Day 85
measure: Safety and tolerability as measured by physical examination
timeFrame: Up to Day 85
Secondary outcomes:
measure: Maximum observed serum concentration (Cmax) of MT-2990
timeFrame: Up to Day 85
measure: Measured time of maximum observed serum concentration (tmax) of MT-2990
timeFrame: Up to Day 85
measure: Apparent terminal elimination half-life (t1/2) of MT-2990
timeFrame: Up to Day 85
measure: AUC from time zero to the last measurable concentration (AUC0-last) of MT-2990
timeFrame: Up to Day 85
measure: AUC from time zero to infinity (AUC0-∞) of MT-2990
timeFrame: Up to Day 85
measure: Terminal elimination rate constant (Kel) of MT-2990
timeFrame: Up to Day 85
measure: Apparent volume of distribution at steady state (Vss) of MT-2990
timeFrame: Up to Day 85
measure: Apparent volume of distribution during terminal phase after IV administration (Vz) of MT-2990
timeFrame: Up to Day 85
measure: Mean residence time from time zero to infinity (MRT0-∞) of MT-2990
timeFrame: Up to Day 85
measure: Apparent serum clearance (CL) of MT-2990
timeFrame: Up to Day 85
measure: Percentage of AUC obtained by extrapolation (%AUCex) of MT-2990
timeFrame: Up to Day 85
measure: Proportion of subjects who develop antibodies against MT-2990 in serum
timeFrame: Up to Day 85
Other outcomes:
Locations:
city: NZ Groningen
country: Netherlands
facility: Pharmaceutical Research Associates (PRA) Health Sciences
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: General Manager
role: STUDY_DIRECTOR
References: