Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000275460
Ethics application status
Approved
Date submitted
21/05/2007
Date registered
22/05/2007
Date last updated
22/05/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase I, Single Ascending Dose, Safety and Pharmacokinetic Study of PN0621 in Healthy Volunteers
Scientific title
A Phase I, Single Ascending Dose, Safety and Pharmacokinetic Study of PN0621 in Healthy Volunteers
Universal Trial Number (UTN)
Trial acronym
PN0621/100
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory dieseases, Healthy Volunteers 1815 0
Condition category
Condition code
Inflammatory and Immune System 1905 1905 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PN0621 'IV-Intravenous' administation starting dose 5mg then increasing in new healthy volunteers for each dose through 10mg,20mg,40mg, 80mg and 160mg until a dose limiting toxicity is reached 'SC-subcutaneous' administration starting dose 20mg then increasing in new healthy volunteers for each dose through 40mg, 80mg, 160mg and 320mg until a dose limiting toxicity is reached.
Intervention code [1] 1772 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2711 0
Safety at baseline for IV administration
Timepoint [1] 2711 0
At baseline and then at 16 days.
Primary outcome [2] 2712 0
Safety for SC administration
Timepoint [2] 2712 0
At baseline and then at 20 days.
Secondary outcome [1] 4576 0
Determination of pharmacokinetic parameters
Timepoint [1] 4576 0
(Measured every other day) over 16 days for IV administration and 20 days for SC administration.

Eligibility
Key inclusion criteria
BMI - Body mass Index' 19 to 29, nromal or clinically acceptable 'ECG - Electrocardiogram'
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Donation or loss of more than 400ml blood within 3 months of study, history of infection, screen positive to Tuberculosis, Hepatitis C, Hepatisis B or Human immunodeficiency virus (HIV)

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
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2051 0
Commercial sector/Industry
Name [1] 2051 0
Peptech Limited
Country [1] 2051 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Peptech Limited
Address
Country
Australia
Secondary sponsor category [1] 1859 0
None
Name [1] 1859 0
N/A
Address [1] 1859 0
Country [1] 1859 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3807 0
St Vincent's Hospital-St Vincent's Hospital HREC
Ethics committee address [1] 3807 0
Darlinghurst NSW2010
Ethics committee country [1] 3807 0
Australia
Date submitted for ethics approval [1] 3807 0
Approval date [1] 3807 0
04/04/2007
Ethics approval number [1] 3807 0
H07/003

Summary
Brief summary
To establish whether the adminstration to humans of the new anti-inflammatory drug PN0621 is safe.
To determine the distribution of PN0621 in the human body to design dosing levels for future trials.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27875 0
Address 27875 0
Country 27875 0
Phone 27875 0
Fax 27875 0
Email 27875 0
Contact person for public queries
Name 10961 0
Lana Sagi
Address 10961 0
Clinical Trials Centre
St Vincent's Hospital
Darlinghurst NSW2010
Country 10961 0
Australia
Phone 10961 0
02 8382 2233
Fax 10961 0
02 8382 2591
Email 10961 0
clinicaltrials@stvincents.com.au
Contact person for scientific queries
Name 1889 0
Dr Robert Gay
Address 1889 0
Peptech Limited
19-25 Khartoum Road
Macquarie Park
NSW 2113
Country 1889 0
Australia
Phone 1889 0
02 9870 8788
Fax 1889 0
02 9870 8787
Email 1889 0
robert@peptech.com

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.