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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03156738
• Other study ID #: MT-2990-E01
• Status: Completed
• Phase: Phase 1
• First received: May 15, 2017
• Last updated: January 16, 2018
• Start date: May 17, 2017
• Est. completion date: December 29, 2017

Study information

• Verified date: January 2018
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 29, 2017
• Est. primary completion date: December 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• MT-2990
Subjects will receive a single IV dose of MT-2990
• Placebo
Subjects will receive a single IV dose of placebo

Locations

Country	Name	City	State
Netherlands	Pharmaceutical Research Associates (PRA) Health Sciences	NZ Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Safety and tolerability as measured by physical examination	Physical examination data will be listed by subject.	Up to Day 85
Secondary	Maximum observed serum concentration (Cmax) of MT-2990	Cmax will be summarised by dose level.	Up to Day 85
Secondary	Measured time of maximum observed serum concentration (tmax) of MT-2990	tmax will be summarised by dose level.	Up to Day 85
Secondary	Apparent terminal elimination half-life (t1/2) of MT-2990	t½ will be summarised by dose level.	Up to Day 85
Secondary	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
Secondary	AUC from time zero to infinity (AUC0-8) of MT-2990	AUC0-8 will be summarised by dose level.	Up to Day 85
Secondary	Terminal elimination rate constant (Kel) of MT-2990	Kel will be summarised by dose level.	Up to Day 85
Secondary	Apparent volume of distribution at steady state (Vss) of MT-2990	Vss will be summarised by dose level.	Up to Day 85
Secondary	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
Secondary	Mean residence time from time zero to infinity (MRT0-8) of MT-2990	MRT0-8 will be summarised by dose level.	Up to Day 85
Secondary	Apparent serum clearance (CL) of MT-2990	CL will be summarised by dose level.	Up to Day 85
Secondary	Percentage of AUC obtained by extrapolation (%AUCex) of MT-2990	%AUCex will be summarised by dose level.	Up to Day 85
Secondary	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