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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Healthy Volunteers, Bacterial Infections

Intervention / Treatment
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* Drug: OP0595
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ascending single dose of OP0595<br> | Drug: OP0595<br>* Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation<br>|
| Placebo Comparator: Normal Saline<br> | Drug: Placebo<br>* Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety from baseline through the end of the study | Number of patients with adverse events | Day 1 to Day 7 | 

Secondary Outcome Measures

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