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

NCT ID: NCT02134834

Last Updated: 2014-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-11-30

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.

Detailed Description

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Conditions

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Healthy Volunteers Bacterial Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ascending single dose of OP0595

Group Type EXPERIMENTAL

OP0595

Intervention Type DRUG

Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation

Normal Saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation

Interventions

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OP0595

Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation

Intervention Type DRUG

Placebo

Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Meiji Seika Pharma Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mitsuharu Egawa

Role: STUDY_CHAIR

Meiji Seika Pharma Co., Ltd.

Locations

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Perth, Western Australia, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED
PMID: 32041717 (View on PubMed)

Other Identifiers

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OP0595-1

Identifier Type: -

Identifier Source: org_study_id