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

Mitsubishi Tanabe Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: MT-2990; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03156738

MT-2990-E01

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 5 patient groups

Dose 1

Experimental group

Description:

MT-2990 or Placebo

Treatment:

Drug: Placebo

Drug: MT-2990

Dose 2

Experimental group

Description:

MT-2990 or Placebo

Treatment:

Drug: Placebo

Drug: MT-2990

Dose 3

Experimental group

Description:

MT-2990 or Placebo

Treatment:

Drug: Placebo

Drug: MT-2990

Dose 4

Experimental group

Description:

MT-2990 or Placebo

Treatment:

Drug: Placebo

Drug: MT-2990

Dose 5

Experimental group

Description:

MT-2990 or Placebo

Treatment:

Drug: Placebo

Drug: MT-2990