NCT02146261

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 44 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study consists of Screening Period, Observation Period, In-patient Period, and Follow-up Period. Screening assessments will be performed within 28 to 2 days before starting the study treatment, and Observation Period assessments will be performed on a day before starting the study treatment to confirm the eligibility of study subjects. The eligible subjects will be randomized into either E6011 arm or placebo arm using the drug allocation list prepared by the random code statistician. Each subjects dosing interval will be at least a 30-minutes.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	E6011	Subcutaneous administration of E6011 (at doses of 50, 100, 200 and 400 mg)
DRUG	Placebo	Subcutaneous administration of placebo

Timeline

• Start date: 2013-09-01
• Primary completion: 2013-12-01
• Completion: 2014-04-01
• First posted: 2014-05-23
• Last updated: 2014-10-22

Locations

1 site across 1 country: Japan