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.

Meiji Seika Pharma Co., Ltd.0 sites40 target enrollmentMay 2014

ConditionsHealthy Volunteers Bacterial Infections

InterventionsOP0595 Placebo

DrugsOP0595 Placebo

Overview

Phase: Phase 1
Intervention: OP0595
Conditions: Healthy Volunteers
Sponsor: Meiji Seika Pharma Co., Ltd.
Enrollment: 40
Primary Endpoint: Safety from baseline through the end of the study
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

November 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Meiji Seika Pharma Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Caucasian males aged between 18 and 45 years (inclusive) at Screening
•A Body Mass Index (BMI) between 18.0 and 30.0 kg/m² (inclusive) at Screening
•Good general health as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests
•Negative urine test for drugs of abuse and breath test for alcohol both at Screening and Day -1

Exclusion Criteria

•Receipt of any investigational agent or drug within four months before Screening
•A history or current evidence of allergic symptoms such as bronchial asthma, drug-induced rash or urticaria
•Hypersensitivity and/or allergy to drugs
•Concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological disorders
•A history of chronic or recurrent infections or current active infection
•A recent history of surgery within three months prior to Screening, determined by the Investigator to be clinically relevant
•A history or presence of malignancy
•Donation of blood (or loss of blood) greater than 400 ml within three months before Screening
•A history of smoking at any time within one year before Screening