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.
The drug being tested in this study is called MT203 (Namilumab), which is a human immunoglobulin G1 (IgG1) mAb potently and specifically neutralizing human and macaque granulocyte macrophage colony stimulating factor (GM-CSF). This study will consist of Cohorts 1 to 3 for healthy Japanese participants and Cohort 4 for healthy Caucasian participants. Each cohort will be comprised of 8 participants, of whom 6 participants will be randomized to receive MT203 and 2 participants will be randomized to receive matched placebo. The study population for the study will consist of 24 Japanese and 8 Caucasian healthy participants. Participants will be assigned to 4 cohorts which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):: Cohort 1:- MT203 80 mg (6 healthy Japanese participants); Matching Placebo (2 healthy Japanese participants) Cohort 2:- MT203 150 mg (6 healthy Japanese participants); Matching Placebo (2 healthy Japanese participants) Cohort 3:- MT203 300 mg (6 healthy Japanese participants); Matching Placebo (2 healthy Japanese participants) Cohort 4:- MT203 150 mg (6 healthy Caucasian participants); Matching Placebo (2 healthy Caucasian participants). Dosing of the Caucasian participants (Cohort 4) may occur in parallel with dosing in Japanese participants (Cohorts 1 to 3). Dose escalation will occur in Japanese Cohorts, independent from Cohort 4. The dose escalation will only occur following a review of the blinded safety/tolerability data up to Day 15 from the previous cohort. All participants will receive a single dose on Day 1, admitted from Day -1 to Day 15. Participants will return to the study unit for the pharmacokinetic, pharmacodynamic and safety assessment on Days 22, 29, 43, 57, 71 and 85. This trial will be conducted in Japan.Overall time to participate in this trial is 85 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
MT203 80 mg or matching placebo injection
MT203 150mg or matching placebo injection
MT203 300 mg or matching placebo injection
Unnamed facility
Kagoshima, Kagoshima-ken, Japan
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
Time frame: Baseline up to Day 85
Number of Participants With TEAEs Related to Vital Signs
Time frame: Baseline up to Day 85
Number of Participants With TEAEs Related to Body Weight
Time frame: Baseline up to Day 85
Number of Participants With TEAEs Related to 12-lead Electrocardiograms (ECG)
Time frame: Baseline up to Day 85
Number of Participants With TEAEs Related to Lung Functioning Monitoring
Time frame: Baseline up to Day 85
Number of Participants With TEAEs Related to Hematology, Serum Chemistry and Urinalysis
Time frame: Baseline up to Day 85
Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUC(0-inf)) of MT203
Time frame: Predose and at multiple time points (up to 84 days) post-dose
Area Under the Serum Concentration-Time Curve From Time 0 to Time 84 Days (AUC(0-84d)) of MT203
Time frame: Predose and at multiple time points (up to 84 days) post-dose
Maximum Observed Serum Concentrations (Cmax) of MT203
Time frame: Predose and at multiple time points (up to Day 84) post-dose
Terminal Elimination Half-Life (T1/2) of MT203
Time frame: Predose and at multiple time points (up to 84 days) post-dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Plasma Total Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Concentration
Time frame: Baseline, Hour 24, 72, 120, 168, 240, 336 hours, Day 21, 28, 42, 56, 70, 84
Number of Participants With Positive Response for Anti MT203 Antibody
Time frame: Baseline, Hour 168, 336, Day 42, 84