NCT02134834

A Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of OP0595

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of OP0595 Administered Intravenously in Healthy Male Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Meiji Seika Pharma Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objectives of this study are to assess the safety, tolerability and pharmacokinetic profile of OP0595 administered intravenously to healthy male, Caucasian, adult subjects at single escalating doses.

Conditions

• Healthy Volunteers
• Bacterial Infections

Interventions

Type	Name	Description
DRUG	OP0595	Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation
DRUG	Placebo	Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-08-01
• Completion: 2014-11-01
• First posted: 2014-05-09
• Last updated: 2014-12-12

Locations

1 site across 1 country: Australia