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Completed

NCT Number: 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

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

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaceutical Research Associates (PRA) Health Sciences

NZ Groningen, 9728, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MT-2990

Drug

Subjects will receive a single IV dose of MT-2990

Placebo

Drug

Subjects will receive a single IV dose of placebo

Primary outcomes

  1. Safety and tolerability as measured by incidence, nature and severity of adverse events

    Time frame: Up to Day 85

    Adverse events will be summarised by dose level.

  2. Safety and tolerability as measured by vital signs

    Time frame: Up to Day 85

    Vital signs variables and changes from Baseline will be summarised by dose level.

  3. Safety and tolerability as measured by ECG parameters

    Time frame: Up to Day 85

    12-lead ECG variables and changes from Baseline will be summarised by dose level.

  4. Safety and tolerability as measured by clinical laboratory assessments

    Time frame: Up to Day 85

    Laboratory variables and changes from Baseline will be summarised by dose level.

  5. Safety and tolerability as measured by physical examination

    Time frame: Up to Day 85

    Physical examination data will be listed by subject.

Secondary outcomes

  1. Maximum observed serum concentration (Cmax) of MT-2990

    Time frame: Up to Day 85

    Cmax will be summarised by dose level.

  2. Measured time of maximum observed serum concentration (tmax) of MT-2990

    Time frame: Up to Day 85

    tmax will be summarised by dose level.

  3. Apparent terminal elimination half-life (t1/2) of MT-2990

    Time frame: Up to Day 85

    t½ will be summarised by dose level.

  4. AUC from time zero to the last measurable concentration (AUC0-last) of MT-2990

    Time frame: Up to Day 85

    AUC0-last will be summarised by dose level.

  5. AUC from time zero to infinity (AUC0-∞) of MT-2990

    Time frame: Up to Day 85

    AUC0-∞ will be summarised by dose level.

  6. Terminal elimination rate constant (Kel) of MT-2990

    Time frame: Up to Day 85

    Kel will be summarised by dose level.

  7. Apparent volume of distribution at steady state (Vss) of MT-2990

    Time frame: Up to Day 85

    Vss will be summarised by dose level.

  8. Apparent volume of distribution during terminal phase after IV administration (Vz) of MT-2990

    Time frame: Up to Day 85

    Vz will be summarised by dose level.

  9. Mean residence time from time zero to infinity (MRT0-∞) of MT-2990

    Time frame: Up to Day 85

    MRT0-∞ will be summarised by dose level.

  10. Apparent serum clearance (CL) of MT-2990

    Time frame: Up to Day 85

    CL will be summarised by dose level.

  11. Percentage of AUC obtained by extrapolation (%AUCex) of MT-2990

    Time frame: Up to Day 85

    %AUCex will be summarised by dose level.

  12. Proportion of subjects who develop antibodies against MT-2990 in serum

    Time frame: Up to Day 85

    The proportion of subjects who develop antibodies against MT 2990 in serum will be summarised using descriptive statistics on the Safety Analysis Set.

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 17, 2017
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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