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

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Meiji Seika Pharma Co., Ltd.

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