Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000260426
Ethics application status
Approved
Date submitted
12/05/2007
Date registered
15/05/2007
Date last updated
26/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase 1 Single-Center, Open-Label Study to Evaluate the Safety and Pharmacokinetics of a Candidate Topical Antimicrobial (NEO101) among Healthy Adult Men
Scientific title
A Phase 1 Single-Center, Open-Label Study to Evaluate the Safety and Pharmacokinetics of a Candidate Topical Antimicrobial (NEO101) among Healthy Adult Men
Secondary ID [1] 365 0
Therapeutic Goods Association Clinical Trial Notification (TGA CTN): YGA CTN - 2007/247 (issued on 03/05/07)
Universal Trial Number (UTN)
Trial acronym
NEO101-CLIN-N002
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Open-label safety pharmacokinetic study in healthy adult men of topical antimicrobial being developed for the indication of nasal carriage of Staphylococcus aureus. 1799 0
Condition category
Condition code
Infection 1886 1886 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
On Day 1 and Day 7 subjects will receive a single topical application of NEO101 to each nostril. On Day 4 through Day 6 subjects will receive a treatment course of three-times-daily topical application of NEO101 to each nostril. Each application consists of 0.1mL 0.95% NEO101 per nostril. Pharmacokinetic blood sampling will be done on Days 1, 4-7, 8 and 10. Safety evaluations will be performed during the treatment course and for 14 days following treatment.
Intervention code [1] 1755 0
Treatment: Drugs
Comparator / control treatment
No comparator/control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2682 0
The primary objective of this study is to evaluate the safety, including pharmacokinetic monitoring, of three-times-daily topical nasal application of NEO101 for 3 days among healthy adult men.
Timepoint [1] 2682 0
Pharmacokinetic blood sampling will be done on Days 1, 4-7, 8 and 10.
Secondary outcome [1] 4538 0
None.
Timepoint [1] 4538 0
None.

Eligibility
Key inclusion criteria
Subjects, in general good health, compliant with (defined) birth control.
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug, have clinical evidence of active cutaneous infection, have had skin or soft tissue infection with S. aureus within 30 days prior to enrollment, have documented disruption of the nasal or facial bones, have atopic dermatitis/eczema, allergic rhinitis, nasal polyps or nasal piercings, have a history of hypersensitivity or allergic reactions to parabens, sodium sulfite or any other ingredient in the formulation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2034 0
Commercial sector/Industry
Name [1] 2034 0
Neosil, Inc
Country [1] 2034 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Neosil, Inc
Address
5980 Horton Street, Suite 525
Emeryville, California 94608
Country
United States of America
Secondary sponsor category [1] 1842 0
None
Name [1] 1842 0
not applicable
Address [1] 1842 0
Country [1] 1842 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3766 0
Q-Pharm Pty Ltd, Clive Berghofer Cancer Research Center-Queensland Institute of Medical Research Human Research Ethics Committee
Ethics committee address [1] 3766 0
300 C Herston Road, Herston, Queensland 4006
Ethics committee country [1] 3766 0
Australia
Date submitted for ethics approval [1] 3766 0
Approval date [1] 3766 0
03/05/2007
Ethics approval number [1] 3766 0
2007/247

Summary
Brief summary
This study will evaluate the safety, including blood sampling for pharmacokinetic monitoring, of a new topical anti-infective (NEO101) applied to each nostril. A single dose will be applied on Day 1 and Day 7 of the study, and three-times-daily doses will be applied on Days 4, 5 and 6.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27858 0
Address 27858 0
Country 27858 0
Phone 27858 0
Fax 27858 0
Email 27858 0
Contact person for public queries
Name 10944 0
Suzanne Elliott, Operations Manager
Address 10944 0
Q-Pharm Pty Ltd
PO Box 78
Royal Brisbane Hospital
Brisbane, Queensland 4029
Country 10944 0
Australia
Phone 10944 0
+61 7 38453644
Fax 10944 0
+61 7 38453637
Email 10944 0
[email protected]
Contact person for scientific queries
Name 1872 0
Andria Langenberg, MD
Address 1872 0
Neosil Inc.
5980 Horton Street
Suite 525
Emeryville California 94608
Country 1872 0
United States of America
Phone 1872 0
+1 510 547 3610, ext 180
Fax 1872 0
+1 510 547 3604
Email 1872 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.