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

Healthy Volunteers Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02134834
• Other study ID #: OP0595-1
• Status: Completed
• Phase: Phase 1
• First received: May 7, 2014
• Last updated: December 11, 2014
• Start date: May 2014
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: Meiji Seika Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Infections
• Healthy Volunteers

Intervention

Drug:
• OP0595
Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation
• Placebo
Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meiji Seika Pharma Co., Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety from baseline through the end of the study	Number of patients with adverse events	Day 1 to Day 7	Yes
Secondary	Plasma PK parameters of OP0595 and its metabolites	Cmax, tmax, AUC0-last, AUC0-inf, Kel, T1/2, CLtot, Vdss	Day 1 to Day 2	No
Secondary	Urine PK parameters of OP0595 and its metabolites	Ae, Ae0-t, Ae0-t/Dose, CLr	Day 1 to Day 2	No