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Trial registered on ANZCTR


Registration number
ACTRN12616000093482
Ethics application status
Approved
Date submitted
20/01/2016
Date registered
29/01/2016
Date last updated
24/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A single dose, randomised, double-blind, placebo-controlled, dose escalation study to evaluate the safety, pharmacokinetics and pharmacodynamics of M012 administered by subcutaneous injection to healthy male volunteers
Scientific title
A single dose, randomised, double-blind, placebo-controlled, dose escalation study to evaluate the safety, pharmacokinetics and pharmacodynamics of M012 administered by subcutaneous injection to healthy male volunteers
Secondary ID [1] 288300 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Beta Thalassemia 297261 0
Condition category
Condition code
Blood 297463 297463 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
M012 (and matching placebo) will be administered at 7 dose levels. Single doses 0.2mg, 0.6mg, 2mg, up to 5mg (exact dose to be decided based on pharmacokinetic information obtained from previous doses), up to 10mg (exact dose to be decided based on pharmacokinetic information obtained from previous doses) , up to 20mg (exact dose to be decided based on pharmacokinetic information obtained from previous doses) and up to 40mg (exact dose to be decided based on pharmacokinetic information obtained from previous doses), will be administered subcutaneously. All doses will be administered on-site by study staff.
Intervention code [1] 293596 0
Treatment: Drugs
Comparator / control treatment
Placebo-controlled. Placebo will be administered via subcutaneous injection into the abdomen. Placebo contains 190 mM trehalose and 50 mM sodium acetate adjusted to pH 5.5 +/- 0.5.
Control group
Placebo

Outcomes
Primary outcome [1] 297114 0
To evaluate the safety and tolerability of a single subcutaneous dose of M012 by monitoring of ECGs, vital signs, physical exams and safety lab results
Timepoint [1] 297114 0
ECG performed at screening, 2 hours and 4 hours post-dose, on Day 1, Day 2, Day 3, Day 4 and as needed on Day 8, Day 15 and Day 29 based on ongoing assessment of adverse events. Vital sign check performed at screening, on Day -1, Day 1, Day 2, Day 3, Day 4, and Day 8. Physical exams will be performed at screening, on Day -1, Day 8, Day 15 and Day 29. Safety labs (Chemistry/Haematology) will be performed at screening, on Day -1, Day 4 and Day 8.
Secondary outcome [1] 320048 0
Pharmacokinetic profile of a single subcutaneous dose of M012, assessed by Cmax, Tmax and AUC determined by blood sample
Timepoint [1] 320048 0
pre-dose,at 5,10, 15,30, 45 minutes and at 1, 1..5, 2, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, and 168 hours post-dose
Secondary outcome [2] 320117 0
Pharmacodynamic effect of M012 on serum iron and transferrin saturation (TSAT) after a single dose of M012
Timepoint [2] 320117 0
30 min pre-dose,at 4,12, 24,36, 48, 60 and 72 hours post-dose as inpatient and on Day 8
Secondary outcome [3] 320201 0
Immunogenicity of a single subcutaneous dose of M012 assessed by anti-drug antibody testing via a blood sample.
Timepoint [3] 320201 0
Pre-dose on Day 1, Day 8, Day 15 and Day 29

Eligibility
Key inclusion criteria
1. Be a healthy male volunteer age 18-60.
2. Have a body mass index (BMI) between 18.5 and 30 kg/m2 (inclusive).
3. Have laboratory values within the reference range unless deemed not clinically significant by the Investigator.
4. Be surgically sterile, using barrier method of contraception or abstain from sexual intercourse from inpatient admission to one month after dosing.
5. Agree to adhere to the protocol-defined schedule of assessments and procedures.
6. Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed.
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Have iron deficiency, iron overload, liver disease, renal disease, chronic inflammatory disease, haemochromatosis, beta thalassemia, glucose 6 phosphate dehydrogenase deficiency or hemolytic anaemia.
2. Be a current smoker.
3. Have alcohol intake outside normal limits (> an average of 3 standard drinks per day).
4. Have received a blood transfusion within the last 3 months.
5. Have positive test result for human immunodeficiency virus (HIV).
6. Have positive test result for hepatitis B surface antigen, or hepatitis C antibody.
7. Have donated blood within 4 weeks of screening.
8. Have had recent (within 4 weeks of screening) significant (greater than or equal to 1 unit) blood loss for any reason.
9. Have any evidence of abnormal iron metabolism. During screening, the following indicators must all be within normal limits: Hb, RBC, reticulocyte count, RDW, haematocrit, TSAT, serum ferritin, serum iron and TIBC.
10. Have participated in an investigational drug trial within 30 days prior to first dose of study drug on Day 1.
11. Have a known hypersensitivity to any ingredient in the study formulation.
12. Have, as determined by the Investigator and/or medical monitor, any clinically relevant medical or surgical condition that could interfere with the administration of study drug, interpretation of study results, or compromise the safety or well-being of the subject.

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 2 / Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/02/2016
Actual
15/02/2016
Date of last participant enrolment
Anticipated
23/05/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292727 0
Commercial sector/Industry
Name [1] 292727 0
Merganser Biotech Australia Pty Ltd.
Country [1] 292727 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Merganser Biotech Australia Pty Ltd.
Address
Floor 19, HWT Tower
40 City Road
Southbank, Victoria, 3006
Australia
Country
Australia
Secondary sponsor category [1] 291424 0
Commercial sector/Industry
Name [1] 291424 0
Clinical Network Services (CNS)
Address [1] 291424 0
Level 4, 88 Jephson Street
Toowong, QLD 4066
Country [1] 291424 0
Australia
Other collaborator category [1] 278775 0
Other
Name [1] 278775 0
Nucleus Network (NN)
Address [1] 278775 0
5th Floor Burnet Tower
89 Commercial Road
Melbourne VIC 3004
Country [1] 278775 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294180 0
Alfred HREC
Ethics committee address [1] 294180 0
Alfred Hospital Commercial Road MELBOURNE VIC 3004
Ethics committee country [1] 294180 0
Australia
Date submitted for ethics approval [1] 294180 0
20/01/2016
Approval date [1] 294180 0
03/02/2016
Ethics approval number [1] 294180 0

Summary
Brief summary
This research project is testing the safety, tolerability and pharmacokinetics (looking at the amount of drug in your blood to evaluate the way the body processes the drug), pharmacodynamics (the response of your body to the drug) and immunogenicity (your immune response to the drug) of a new drug called M012 when it is given as a single dose.
M012 is an injection into the skin of your abdomen to be administered by a trained professional.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62686 0
Dr Jason Lickliter
Address 62686 0
Nucleus Network
Level 5 Burnet Institute
AMREP Precinct
89 Commercial Road
Melbourne, Victoria 3004
Country 62686 0
Australia
Phone 62686 0
+61 3 9076 8960
Fax 62686 0
Email 62686 0
j.lickliter@nucleusnetwork.com.au
Contact person for public queries
Name 62687 0
Miss Elaine Wong
Address 62687 0
Nucleus Network
Level 5 Burnet Institute
AMREP Precinct
89 Commercial Road
Melbourne, Victoria 3004
Country 62687 0
Australia
Phone 62687 0
+61 3 9076 8958
Fax 62687 0
Email 62687 0
e.wong@nucleusnetwork.com.au
Contact person for scientific queries
Name 62688 0
Mr Mark Falone
Address 62688 0
Merganser Biotech
1004 W. 9th Avenue
Suite 115
King of Prussia, PA 19406
Country 62688 0
United States of America
Phone 62688 0
+1 484 753 2408
Fax 62688 0
Email 62688 0
mfalone@merganserbiotech.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

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