Clinical trial NCT02354599
Conditions: Healthy Volunteers
Keywords: Randomized, double-blind, placebo-controlled, single-dose subcutaneous administration study
Sponsor: Takeda
Start date: 2014-11-01; Completion date: 2015-05-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:
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.

Arms: arm 1: Six Japanese participants will be randomized to receive a single dose of MT203 80 mg and 2 participants will be randomized to receive matched placebo subcutaneously. arm 2: Six Japanese participants will be randomized to receive a single dose of MT203 80 mg and 2 participants will be randomized to receive matched placebo subcutaneously. arm 3: Six Japanese participants will be randomized to receive a single dose of MT203 150 mg and 2 participants will be randomized to receive matched placebo subcutaneously. arm 4: Six Caucasian participants will be randomized to receive a single dose of MT203 150 mg and 2 participants will be randomized to receive matched placebo subcutaneously. arm 5: Six Japanese participants will be randomized to receive a single dose of MT203 300 mg and 2 participants will be randomized to receive matched placebo subcutaneously. arm 6: Six Japanese participants will be randomized to receive a single dose of MT203 300 mg and 2 participants will be randomized to receive matched placebo subcutaneously. arm 7: Six Caucasian participants will be randomized to receive a single dose of MT203 150 mg and 2 participants will be randomized to receive matched placebo subcutaneously. arm 8: Six Caucasian participants will be randomized to receive a single dose of MT203 150 mg and 2 participants will be randomized to receive matched placebo subcutaneously
Interventions: intervention 1: MT203 80 mg or matching Placebo intervention 2: MT203 150mg or matching Placebo intervention 3: MT203 300 mg or matching placebo
Intervention descriptions: intervention 1: MT203 80 mg or matching placebo injection intervention 2: MT203 150mg or matching placebo injection intervention 3: MT203 300 mg or matching placebo injection

Protocol documents: