Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000233224
Ethics application status
Approved
Date submitted
18/03/2009
Date registered
8/05/2009
Date last updated
13/10/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
A Single-Dose Safety and Tolerability Placebo Controlled Study of Subcutaneous SCH 900222 in Healthy Volunteers
Scientific title
A Single-Dose Safety and Tolerability Placebo Controlled Study of Subcutaneous SCH 900222 in Healthy Volunteers
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The use of SCH 900222 for autoimmune disorders. 4497 0
Condition category
Condition code
Inflammatory and Immune System 4778 4778 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single dose of either 50mg or 200mg SCH 900222 administered as a subcutaneous single injection.
Intervention code [1] 4246 0
Treatment: Drugs
Comparator / control treatment
Subcutaneous single injection of placebo (saline solution).
Control group
Placebo

Outcomes
Primary outcome [1] 5638 0
To determine the safety and tolerability of a rising single subcutaneous fixed dose of SCH 900222 in healthy subjects.
(Assessed via vital sign measurements, standard laboratory safety tests, urinalysis &/or physical examinations)
Timepoint [1] 5638 0
Assessed throughout the study at each study visit between Days 1-140 (13 visits).
Secondary outcome [1] 241522 0
To determine the relative bioavailability and pharmacokinetics of rising subcutaneous dose of SCH 900222 compared to parallel intravenous dosing in healthy subjects. (Assessed via pharmacokinetic (PK) blood sample analysis)
Timepoint [1] 241522 0
Assessed throughout the study at each study visit between Days 1-140 (13 visits).

Eligibility
Key inclusion criteria
-Male/Female Healthy volunteers must have no history of latent or active tuberculosis (TB) prior to screening
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of malignancy, Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C, active or latent mycobacterium tuberculosis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4685 0
Commercial sector/Industry
Name [1] 4685 0
Schering-Plough
Country [1] 4685 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Schering-Plough
Address
2000 Galloping Hill Road
Kenilworth, New Jersey 07033
USA
Country
Australia
Secondary sponsor category [1] 4230 0
None
Name [1] 4230 0
Address [1] 4230 0
Country [1] 4230 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6723 0
Ethics committee address [1] 6723 0
Ethics committee country [1] 6723 0
Date submitted for ethics approval [1] 6723 0
23/02/2009
Approval date [1] 6723 0
Ethics approval number [1] 6723 0

Summary
Brief summary
This study will evaluate the safety, tolerability, & pharmacokinetic response to SCH 900222 subcutaneous fixed dose in healthy subjects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27570 0
Address 27570 0
Country 27570 0
Phone 27570 0
Fax 27570 0
Email 27570 0
Contact person for public queries
Name 10825 0
Mary Franich
Address 10825 0
Centre for Clinical Studies
5th floor Burnet Tower
AMREP Precinct
89 Commercial Rd
Melbourne
VIC 3004
Country 10825 0
Australia
Phone 10825 0
1800-243-733
Fax 10825 0
Email 10825 0
[email protected]
Contact person for scientific queries
Name 1753 0
Dr Peter Hodsman
Address 1753 0
Centre for Clinical Studies
5th floor Burnet Tower
AMREP Precinct
89 Commercial Rd
Melbourne
VIC 3004
Country 1753 0
Australia
Phone 1753 0
+61 3 9076 8960
Fax 1753 0
Email 1753 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.