A Phase 1 Study of Single-dose Subcutaneous E6011 in Japanese Healthy Adult Male Subjects

Summary

This study (Protocol No. E6011-J081-002) is a single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to evaluate mainly the safety and tolerability of a single subcutaneous administration of E6011. A total of 32 subjects will be randomized into four cohorts (50, 100, 200 and 400 mg groups). Of eight subjects per cohort, six subjects will receive the single subcutaneous E6011 administration and two subjects will receive the single subcutaneous placebo administration.

Timeline

Start

2013-09

Primary completion

2013-12

Completion

2014-04

Drugs

Indications

No indication recorded.