Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000200684
Ethics application status
Approved
Date submitted
18/02/2014
Date registered
25/02/2014
Date last updated
24/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase I, Randomised, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Doses of ATL1102 Alone and in Combination with G-CSF in Healthy Volunteers
Scientific title
A Phase I, Randomised, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Doses of ATL1102 Alone and in Combination with G-CSF in Healthy Volunteers
Secondary ID [1] 283970 0
Protocol 1102SCM-CT01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stem cell mobilisation 290998 0
Condition category
Condition code
Blood 291342 291342 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group A: comparator only
Group B: Investigational product only
Group C: Comparator and investigational product (administered at same time)

Investigational product: 150mg/mL ATL1102 for subcutaneous administration at a dose of 400 mg daily, to be administered on days 1, 3 and 5 to Groups B and C.
Intervention code [1] 288655 0
Treatment: Drugs
Comparator / control treatment
Group A: comparator only
Group B: Investigational product only
Group C: Comparator and investigational product (administered at same time)

G-CSF (filgrastim, Neupogen (registered trademark)) for subcutaneous administration at a dose of 10 micro g/kg daily, to be administered on days 1, 2, 3, 4 and 5 to Groups A and C
Control group
Active

Outcomes
Primary outcome [1] 291337 0
Safety and tolerability of subcutaneous doses of ATL1102 alone, and in combination with G-CSF in healthy volunteers
Timepoint [1] 291337 0
- Signs, symptoms or markers of end organ or systemic toxicity during the 14 day study period
- Physical examination changes during the 14 day study period
- Vital signs (temperature, respiration rate, pulse rate, blood pressure) pre and post dose and in follow up.
- Adverse event questioning and recording throughout the 14 day study
- 12-lead ECG (including heart rate, PR, QRS and QTc interval) pre and post dose and in follow up.
- Clinical laboratory assessments including haematology, biochemistry, coagulation studies and urinalysis pre and post dose and in follow up
- Complement Bb pre and post dose and in follow up.
Primary outcome [2] 291338 0
To assess the plasma pharmacodynamics of ATL1102 alone, and in combination with G-CSF in healthy volunteers
Timepoint [2] 291338 0
Cmax, Tmax, and AUC after single (Day 1) and multiple doses of ATL1102 (Days 3, 6, 7, 8 and 14)
Secondary outcome [1] 306553 0
None
Timepoint [1] 306553 0
NA

Eligibility
Key inclusion criteria
- Provide written informed consent
- Male subjects 18 – 50 years of age inclusive
- Body Mass Index (BMI) >=19 and <= 32 kg/m2
- Healthy as determined by medical and drug history, physical examination, vital signs, clinical laboratory testings including urinalysis, and ECG.
Minimum age
18 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Allergy and/or hypersensitivity to any of the ingredients of ATL1102 or to E. coli derived proteins, filgrastim, or any component of Neupogen (registered trademark).
- History or presence of clinically significant haematological abnormalities
- Current or prior history within the last 5 years of cancer (except for treated BCC SCC of the skin with no evidence of recurrence)
- History or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, ocular, or infectious disease, or any acute infectious disease.
- Received an investigational drug within 30 days or 5 half-lives prior to the first dose of study drug, whichever is the longer period.
- Blood donation or loss of >500ml within 3 months prior to the first dose of study drug

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
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2014
Actual
1/04/2014
Date of last participant enrolment
Anticipated
Actual
1/04/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288603 0
Commercial sector/Industry
Name [1] 288603 0
Antisense Therapeutics
Country [1] 288603 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Antisense Therapeutics
Address
6 Wallace Avenue
Toorak 3142
Victoria
Country
Australia
Secondary sponsor category [1] 287313 0
None
Name [1] 287313 0
Address [1] 287313 0
Country [1] 287313 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290465 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 290465 0
Ethics committee country [1] 290465 0
Australia
Date submitted for ethics approval [1] 290465 0
Approval date [1] 290465 0
20/12/2013
Ethics approval number [1] 290465 0
EC00315

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44414 0
Dr Jason Lickliter
Address 44414 0
Nucleus Network Ltd
Level 5, 89 Commercial Road
Melbourne VIC 3004
Country 44414 0
Australia
Phone 44414 0
+61 3 9076 8960
Fax 44414 0
Email 44414 0
[email protected]
Contact person for public queries
Name 44415 0
Sue Turner
Address 44415 0
Antisense Therapeutics
6 Wallace Avenue
Toorak VIC 3142
Country 44415 0
Australia
Phone 44415 0
+61 3 9827 8999
Fax 44415 0
Email 44415 0
[email protected]
Contact person for scientific queries
Name 44416 0
Lynne Atley
Address 44416 0
Antisense Therapeutics
6 Wallace Avenue
Toorak VIC 3142
Country 44416 0
Australia
Phone 44416 0
+61 3 9827 8999
Fax 44416 0
Email 44416 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.