Healthy Japanese and Caucasian Male Adults Clinical Trial
Official title:
A Phase 1, Single-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Subcutaneous Injection of MLN1202 in the Japanese and Caucasian Healthy Male Participants
The objective of the study is to investigate the safety, pharmacokinetics, and pharmacodynamic effect of a single dose of MLN1202 in healthy Japanese male adults.
This is a single dose, phase 1 study in healthy Japanese and Caucasian male adults.
Japanese subjects will be assigned to Cohort J1 (at a dose of 75 mg), Cohort J2 (105 mg),
Cohort J3 (150 mg), or Cohort J4 (450 mg) in a randomized, double-blind, placebo-controlled
manner, while Caucasian subjects to Cohort C1 (at a dose of 75 mg) or Cohort C2 (150 mg) in
an open-label manner.
Takeda has made a business decision to terminate this study due to portfolio
re-prioritization. There were no safety or efficacy concerns.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment