CompletedNCT03156738Updated Jan 18, 2018

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 Phase 1 interventional study of MT-2990 and Placebo in Healthy, sponsored by Mitsubishi Tanabe Pharma Corporation. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-18.

Sponsored by Mitsubishi Tanabe Pharma Corporation · Phase 1, Interventional, and Other

Phase: Phase 1
Study type: Interventional
Enrollment: 40
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: Male

Study summary

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

Conditions studied

Healthy

In context

Lead sponsor

Mitsubishi Tanabe Pharma Corporation is the lead sponsor of 40 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: Male
Accepts 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

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 design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 40 participants (actual)

Study arms

Experimental
Dose 1
MT-2990 or Placebo
Drug: MT-2990 · Drug: Placebo
Experimental
Dose 2
MT-2990 or Placebo
Drug: MT-2990 · Drug: Placebo
Experimental
Dose 3
MT-2990 or Placebo
Drug: MT-2990 · Drug: Placebo
Experimental
Dose 4
MT-2990 or Placebo
Drug: MT-2990 · Drug: Placebo
Experimental
Dose 5
MT-2990 or Placebo
Drug: MT-2990 · Drug: Placebo

Interventions

DrugMT-2990
Subjects will receive a single IV dose of MT-2990
DrugPlacebo
Subjects will receive a single IV dose of placebo

What researchers measure

Primary outcomes

Safety and tolerability as measured by incidence, nature and severity of adverse events
Adverse events will be summarised by dose level.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Day 85
Safety and tolerability as measured by physical examination
Physical examination data will be listed by subject.
Time frame: Up to Day 85

Secondary outcomes

Maximum observed serum concentration (Cmax) of MT-2990
Cmax will be summarised by dose level.
Time frame: Up to Day 85
Measured time of maximum observed serum concentration (tmax) of MT-2990
tmax will be summarised by dose level.
Time frame: Up to Day 85
Apparent terminal elimination half-life (t1/2) of MT-2990
t½ will be summarised by dose level.
Time frame: 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.
Time frame: Up to Day 85
AUC from time zero to infinity (AUC0-∞) of MT-2990
AUC0-∞ will be summarised by dose level.
Time frame: Up to Day 85
Terminal elimination rate constant (Kel) of MT-2990
Kel will be summarised by dose level.
Time frame: Up to Day 85
Apparent volume of distribution at steady state (Vss) of MT-2990
Vss will be summarised by dose level.
Time frame: 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.
Time frame: Up to Day 85
Mean residence time from time zero to infinity (MRT0-∞) of MT-2990
MRT0-∞ will be summarised by dose level.
Time frame: Up to Day 85
Apparent serum clearance (CL) of MT-2990
CL will be summarised by dose level.
Time frame: Up to Day 85
Percentage of AUC obtained by extrapolation (%AUCex) of MT-2990
%AUCex will be summarised by dose level.
Time frame: 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.
Time frame: Up to Day 85

Study locations

1 site

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03156738
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Responsible party: Sponsor
First posted: May 17, 2017
Start date: May 17, 2017
Primary completion: Dec 29, 2017
Completion: Dec 29, 2017
Last update: Jan 18, 2018

Study contacts

General Manager

study director · Mitsubishi Tanabe Pharma Corporation

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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