Single-Dose Study of MT203
Condition: Healthy Volunteers
Intervention: MT203 80 mg or matching Placebo; MT203 150mg or matching Placebo; MT203 300 mg or matching placebo
Intervention description: MT203 80 mg or matching placebo injection; MT203 150mg or matching placebo injection; MT203 300 mg or matching placebo injection
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Randomized, double-blind, placebo-controlled, single-dose subcutaneous administration study

Summary:

      The purpose of this study is to evaluate safety, pharmacokinetics and pharmacodynamics of
      single subcutaneous injection of MT203 in healthy adult Japanese and Caucasian male
      participants.
    

Eligibility criteria:

        Inclusion Criteria: -

          1. In the opinion of the investigator, the participant is capable of understanding and
             complying with protocol requirements.

          2. The participant signs and dates a written, informed consent form and any required
             privacy authorizations prior to the initiation of any study procedures.

          3. The participant is a healthy adult male of Japanese or Caucasian (born to Caucasian
             parents and grandparents).

          4. The participant is aged 20 to 45 years, inclusive, at the time of informed consent.

          5. The participant weighs at least 50 kilogram (kg) and has a body mass index (BMI)
             between 18.5 and 25.0 kilogram per square meter (kg/m2) (for Japanese) or between 18.5
             and 30.0 kg/m2 (for Caucasian), inclusive at screening and Day-1.

          6. A male participant who is nonsterilized and sexually active with a female partner of
             childbearing potential agrees to use adequate contraception from signing of informed
             consent throughout the duration of the study and for 18 weeks (126 days) after last
             dose.

        Exclusion Criteria: -

          1. The participant has received any investigational compound within 16 weeks (112 days)
             prior to the first dose of study medication.

          2. The participant has received MT203 or other anti-granulocyte-macrophage colony
             stimulating factor (GM-CSF) drugs in a previous clinical study.

          3. The participant has been vaccinated within 4 weeks (28 days) prior to the first dose
             of study medication or is scheduled to be vaccinated during the study.

          4. The participant is an immediate family member, study site employee or may consent
             under duress.

          5. The participant has uncontrolled, clinically significant neurologic, cardiovascular,
             pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, or endocrine disease
             or other abnormalities, which may impact the ability of the participant to participate
             or potentially confound the study results.

          6. History of frequent or chronic infections or herpes zoster.

          7. The participant has a history of or currently has significant pulmonary disease,
             inflammatory disease or autoimmune disease.

          8. The participant has a known hypersensitivity to any component of the formulation of
             MT203.

          9. The participant has a positive urine drug result for drugs of abuse at screening. 10.
             The participant has a history of drug abuse (defined as any illicit drug use) or a
             history of alcohol abuse within 2 years prior to the screening visit or is unwilling
             to agree to abstain from alcohol and drugs throughout the study.

        11. The participant has taken or requires excluded medications, supplements or food
        products listed in the Excluded Medications section throughout the study.

        12. The participant intends to donate sperm during the course of this study or for 18 weeks
        after the last dose of study medication.

        13. The participant has a history of cancer. 14. Presence, suspicion or history of active
        tuberculosis (TB) or latent TB infection.

        15. The participant has a positive test result for hepatitis B virus (HBV) surface antigen
        (HBsAg), hepatitis B virus antibody (HBV surface virus antibody [HBsAb]/ HBV core antibody
        [HBcAb]), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV)
        antibody/antigen at screening. However, participants who are positive for HBsAb due to HBV
        vaccination are exempt.

        16. The participant has used nicotine-containing products (including but not limited to
        cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 4 weeks
        (28 days) prior to the first dose of study medication.

        17. The participant has clinically relevant decreased lung function, example, forced
        expiratory volume in the first second (FEV1) less than (<) 70 percent (%) of the predicted
        value.

        18. The participant has poor peripheral venous access. 19. The participant has undergone
        whole blood collection of at least 200 milliliter (mL) within 4 weeks (28 days) or at least
        400 mL within 12 weeks (84 days) prior to the first dose of study medication.

        20. The participant has undergone whole blood collection of at least 800 mL in total within
        52 weeks (364 days) prior to the first dose of study medication.

        21. The participant has undergone blood component collection within 2 weeks (14 days) prior
        to the start of study medication administration.

        22. Participant has an abnormal (clinically significant) electrocardiogram (ECG) at
        screening or Day 1.

        23. The participant has abnormal laboratory values at screening or Day-1 that suggest a
        clinically significant underlying disease or participant with the following laboratory
        abnormalities: Alanine transaminase (ALT) and/or aspartate transaminase (AST) greater than
        (>) 1.5 times the upper limit of normal or neutrophil counts and/or monocyte counts < the
        lower limit of normal.

        24. Participant who, in the opinion of the investigator, is unlikely to comply with the
        protocol or is unsuitable for the study with any other reason.