Healthy Volunteers Clinical Trial
Official title:
A Randomized, Single-center, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate Safety and Pharmacokinetics of Single Subcutaneous Injection of MT203 in Healthy Adult Japanese and Caucasian Male Participants
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 MT-203 (Namilumab), which is a human
immunoglobulin G1 (IgG1) mAb potently and specifically neutralizing human and macaque
GM-CSF(granulocyte macrophage colony stimulating factor).
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 whome 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 wil 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
Japanee participants) Cohort 2:- MT203 150 mg (6 healthy Japanese participants); Matching
Placebo (2 healthy Japanee participants) Cohort 3:- MT203 300 mg (6 healthy Japanese
participants); Matching Placebo (2 healthy Japanee 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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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