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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: MT-2990; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • NZ Groningen, Netherlands, 9728
    • Pharmaceutical Research Associates (PRA) Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dose 1; MT-2990 or Placebo	Drug: MT-2990; Subjects will receive a single IV dose of MT-2990; Drug: Placebo; Subjects will receive a single IV dose of placebo
EXPERIMENTAL: Dose 2; MT-2990 or Placebo	Drug: MT-2990; Subjects will receive a single IV dose of MT-2990; Drug: Placebo; Subjects will receive a single IV dose of placebo
EXPERIMENTAL: Dose 3; MT-2990 or Placebo	Drug: MT-2990; Subjects will receive a single IV dose of MT-2990; Drug: Placebo; Subjects will receive a single IV dose of placebo
EXPERIMENTAL: Dose 4; MT-2990 or Placebo	Drug: MT-2990; Subjects will receive a single IV dose of MT-2990; Drug: Placebo; Subjects will receive a single IV dose of placebo
EXPERIMENTAL: Dose 5; MT-2990 or Placebo	Drug: MT-2990; Subjects will receive a single IV dose of MT-2990; Drug: Placebo; Subjects will receive a single IV dose of placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mitsubishi Tanabe Pharma Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 17, 2017
• Primary Completion (ACTUAL): December 29, 2017
• Study Completion (ACTUAL): December 29, 2017

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (ACTUAL): May 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2018
• Last Update Submitted That Met QC Criteria: January 16, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: MT-2990-E01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No