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

NCT03156738 | Completed Phase 1

• 1 other identifier: MT-2990-E01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (12)

• Maximum observed serum concentration (Cmax) of MT-2990

  Up to Day 85

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

  Up to Day 85

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

  Up to Day 85

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

  Up to Day 85

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

  Up to Day 85

Study Arms (5)

Dose 1

EXPERIMENTAL

MT-2990 or Placebo

Drug: MT-2990; Drug: Placebo

Dose 2

EXPERIMENTAL

MT-2990 or Placebo

Drug: MT-2990; Drug: Placebo

Dose 3

EXPERIMENTAL

MT-2990 or Placebo

Drug: MT-2990; Drug: Placebo

Dose 4

EXPERIMENTAL

MT-2990 or Placebo

Drug: MT-2990; Drug: Placebo

Dose 5

EXPERIMENTAL

MT-2990 or Placebo

Drug: MT-2990; Drug: Placebo

Interventions

MT-2990 DRUG

Subjects will receive a single IV dose of MT-2990

Dose 1; Dose 2; Dose 3; Dose 4; Dose 5

Placebo DRUG

Subjects will receive a single IV dose of placebo

Dose 1; Dose 2; Dose 3; Dose 4; Dose 5

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Pharmaceutical Research Associates (PRA) Health Sciences

NZ Groningen, 9728, Netherlands

Location

Study Officials

• General Manager

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 17, 2017
• Study Start: May 17, 2017
• Primary Completion: December 29, 2017
• Study Completion: December 29, 2017
• Last Updated: January 18, 2018

Record last verified: 2018-01

Locations

NL (1)