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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02134834

Enrollment

Registered

2014-05-09

Start date

2014-05-31

Completion date

2014-11-30

Last updated

2014-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infections, Healthy Volunteers

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.

Interventions

DRUGOP0595

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026