Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000363088
Ethics application status
Not yet submitted
Date submitted
4/05/2010
Date registered
6/05/2010
Date last updated
6/05/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Ascending dose of F-627 in Healthy Male Volunteers
Scientific title
Phase I, Open Labeled, Dose Escalation trial in healthy male subjects to examine the Pharmacokinetics, Pharmacodynamics, and safety of single dose usage of F-627.
Secondary ID [1] 251673 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neutropenia 257276 0
Condition category
Condition code
Blood 257424 257424 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ascending dose of F-627
Cohort 1 will receive 30ug/kg F-627 in a single subcutaneous dose
Cohort 2 will receive 60ug/kg F-627 in a single subcutaneous dose
Cohort 3 will receive 120ug/kg F-627 in a single subcutaneous dose
Cohort 4 will receive 240ug/kg F-627 in a single subcutaneous dose
Intervention code [1] 256394 0
Treatment: Drugs
Comparator / control treatment
4 groups will be compared
Control group
Dose comparison

Outcomes
Primary outcome [1] 258343 0
Safety and tolerability of F-627 at 30ug/kg, 60ug/kg,120ug/kg & 240ug/kg will be assessed on the basis of adverse events reported (such as spenomegaly, bone pain) , vital signs , routine safety blood samples (clinical chemistry, haematology) and abdominal ultrasound for the assessment of splenomegaly.
Timepoint [1] 258343 0
Patients will be continuously monitored whilst they are on study as an inpatient for 3 days following dose administration, and then via a series of clinic visits at Days 4,5,6,7,9,11,13 and 15 post study drug administration.
Secondary outcome [1] 264062 0
To assess the affect of a single subcutaneous dose of 30ug/kg, 60ug/kg, 120ug/kg & 240ug/kg of F-627 in healthy adult male volunteers via pharmacokinetic/ pharmacodynamic effects of F-627 as assessed by blood analysis.
Timepoint [1] 264062 0
Patients will be continuously monitored whilst they are on study as an inpatient for 3 days following dose administration, and then via a series of clinic visits on Days 4,5,6,7,9,11,13 and 15 post study drug administration.

Eligibility
Key inclusion criteria
* Subjects must be healthy male volunteers
* Subjects must have a body mass index greater than or equal to 19 (kg/m2)and less than or equal to 34 (kg/m2).
*No clinically significant findings in the medical and physical examination, especially normal full blood count (at screening), hepatic and renal function.
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Family history of premature CHD (Coronary Heart Disease)
* Any condition which can cause splenomegaly
* Exposure to prescription medications or to drugs known to interfere with metabolism of drugs within 30 days prior to screening
* Prior history of a haematological malignancy, or current history of a haematological disorder (even if it does not require treatment)
* Any abnormality of red cell count, mean corpuscular volume,platelet count, white cell count or white cell differential
* Subjects at risk of tuberculosis (TB)

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
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256904 0
Commercial sector/Industry
Name [1] 256904 0
Generon (Shanghai) Corporation
Country [1] 256904 0
China
Primary sponsor type
Commercial sector/Industry
Name
Nucleus Network
Address
Level 5, AMREP Precinct
89 Commercial Road
Melbourne, Victoria 3004
Country
Australia
Secondary sponsor category [1] 256176 0
None
Name [1] 256176 0
Address [1] 256176 0
Country [1] 256176 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258913 0
The Alfred Human Research Ethics Committee
Ethics committee address [1] 258913 0
The Alfred Hospital
55 Commercial Road
Melbourne, Victoria 3004
Ethics committee country [1] 258913 0
Australia
Date submitted for ethics approval [1] 258913 0
31/03/2010
Approval date [1] 258913 0
Ethics approval number [1] 258913 0
95/10

Summary
Brief summary
Neutropenia is a complex haematological disorder charactarised by a abnormally low level of neutrophils in the blood. F-627 is being developed to treat neutropenia especially for the management of neutropenia in patients with cancer.

F-627 is being developed by Generon (Shanghai) Corporation to provide additional benefits to cancer patients by shortening the duration and lessening the severity of neutropenia after chemotherapy.

The purpose of this study is to researech the safety of the use of F-627 in Healthy Male Volunteers. There will be no benefits from participating in this trial, Patients will receive only one dose of study drug.
Trial website
http://www.nucleusnetwork.com.au/page.aspx?54
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31117 0
Address 31117 0
Country 31117 0
Phone 31117 0
Fax 31117 0
Email 31117 0
Contact person for public queries
Name 14364 0
Mary Franich
Address 14364 0
Nucleus Network Limited
5th Floor Burnet Tower, AMREP Precinct, 89 Commercial Road Melbourne, Victoria 3004
Country 14364 0
Australia
Phone 14364 0
1800 243 733
Fax 14364 0
+61 3 9076 8911
Email 14364 0
[email protected]
Contact person for scientific queries
Name 5292 0
Associate Prof Peter Hodsman
Address 5292 0
Nucleus Network Limited
5th Floor Burnet Tower, AMREP Precinct, 89 Commercial Road, Melbourne, Victoria 3004
Country 5292 0
Australia
Phone 5292 0
+ 61 3 9076 8900
Fax 5292 0
+ 61 3 9076 8911
Email 5292 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
SourceTitleYear of PublicationDOI
EmbaseEfbemalenograstim Alfa: First Approval.2023https://dx.doi.org/10.1007/s40265-023-01911-7
N.B. These documents automatically identified may not have been verified by the study sponsor.