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

NCT ID: NCT03156738

Last Updated: 2018-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-17
• Study Completion Date: 2017-12-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Dose 1

MT-2990 or Placebo

Group Type: EXPERIMENTAL

MT-2990

Intervention Type: DRUG

Subjects will receive a single IV dose of MT-2990

Placebo

Intervention Type: DRUG

Subjects will receive a single IV dose of placebo

Dose 2

MT-2990 or Placebo

Group Type: EXPERIMENTAL

MT-2990

Intervention Type: DRUG

Subjects will receive a single IV dose of MT-2990

Placebo

Intervention Type: DRUG

Subjects will receive a single IV dose of placebo

Dose 3

MT-2990 or Placebo

Group Type: EXPERIMENTAL

MT-2990

Intervention Type: DRUG

Subjects will receive a single IV dose of MT-2990

Placebo

Intervention Type: DRUG

Subjects will receive a single IV dose of placebo

Dose 4

MT-2990 or Placebo

Group Type: EXPERIMENTAL

MT-2990

Intervention Type: DRUG

Subjects will receive a single IV dose of MT-2990

Placebo

Intervention Type: DRUG

Subjects will receive a single IV dose of placebo

Dose 5

MT-2990 or Placebo

Group Type: EXPERIMENTAL

MT-2990

Intervention Type: DRUG

Subjects will receive a single IV dose of MT-2990

Placebo

Intervention Type: DRUG

Subjects will receive a single IV dose of placebo

Interventions

MT-2990

Subjects will receive a single IV dose of MT-2990

Intervention Type: DRUG

Placebo

Subjects will receive a single IV dose of placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mitsubishi Tanabe Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

General Manager

Role: STUDY_DIRECTOR

Mitsubishi Tanabe Pharma Corporation

Locations

Pharmaceutical Research Associates (PRA) Health Sciences

NZ Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

MT-2990-E01

Identifier Type: -

Identifier Source: org_study_id