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

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.

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.

Study Overview

• Status: Completed
• Conditions: Bacterial Infections; Healthy Volunteers
• Intervention / Treatment: Drug: OP0595; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Western Australia
    • Perth,, Western Australia, Australia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Meiji Seika Pharma Co., Ltd.

Publications and helpful links

General Publications

• Mallalieu NL, Winter E, Fettner S, Patel K, Zwanziger E, Attley G, Rodriguez I, Kano A, Salama SM, Bentley D, Geretti AM. Safety and Pharmacokinetic Characterization of Nacubactam, a Novel beta-Lactamase Inhibitor, Alone and in Combination with Meropenem, in Healthy Volunteers. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e02229-19. doi: 10.1128/AAC.02229-19. Print 2020 Apr 21.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: May 7, 2014
• First Submitted That Met QC Criteria: May 7, 2014
• First Posted (Estimate): May 9, 2014

Study Record Updates

• Last Update Posted (Estimate): December 12, 2014
• Last Update Submitted That Met QC Criteria: December 11, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections
• Other Study ID Numbers: OP0595-1