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

Phase 1

Completed

• Conditions: Healthy Volunteers; Bacterial Infections
• Interventions: Drug: OP0595; Drug: Placebo

• Registration Number: NCT02134834
• Lead Sponsor: Meiji Seika Pharma Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-07
• Study First Submitted QC: 2014-05-07
• Study First Posted: 2014-05-09
• Primary Completion: 2014-08
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-11
• Last Update Posted: 2014-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ascending single dose of OP0595	OP0595	-
Normal Saline	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety from baseline through the end of the study	Day 1 to Day 7	Number of patients with adverse events

Secondary Outcome Measures

Name	Time	Method
Urine PK parameters of OP0595 and its metabolites	Day 1 to Day 2	Ae, Ae0-t, Ae0-t/Dose, CLr
Plasma PK parameters of OP0595 and its metabolites	Day 1 to Day 2	Cmax, tmax, AUC0-last, AUC0-inf, Kel, T1/2, CLtot, Vdss