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

Meiji Seika Pharma

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Bacterial Infections

Treatments

Drug: Placebo

Drug: OP0595

Study type

Interventional

Funder types

Industry

Identifiers

NCT02134834

OP0595-1

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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