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

NCT02134834 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-12-12

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Meiji Seika Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Mitsuharu Egawa · Meiji Seika Pharma Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-08-31
Completion
2014-11-30

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02134834 on ClinicalTrials.gov