Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
[email protected]
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
[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.