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Trial registered on ANZCTR


Registration number
ACTRN12612001033831
Ethics application status
Approved
Date submitted
19/09/2012
Date registered
26/09/2012
Date last updated
19/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
An assessment of the safety and pharmacokinetic of ascending doses of sanguinate (Trademark) in healthy volunteers
Scientific title
A single-blind, placebo-controlled, single dose, safety and pharmacokinetic study of 3 ascending doses of SANGUINATE in 3 cohorts of healthy volunteers
Secondary ID [1] 281261 0
Nil
Universal Trial Number (UTN)
U1111-1134-8739
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Effect of the drug Sanguinate on healthy volunteers 287458 0
Condition category
Condition code
Other 287797 287797 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single-blind, placebo-controlled, single dose, safety and pharmacokinetic study of 3 ascending doses of SANGUINATE in 3 cohorts of healthy volunteers. Twenty four (24) eligible healthy volunteers will be sequentially enrolled into one of 3 dosing cohorts, each consisting of no less than three
males and no less than three females. Within each cohort, two subjects will receive placebo (saline) and six subjects will receive active treatment. Active treatment will be consists of 2,4 & 8 ml per kg for 1st, 2nd and 3rd cohort respectively which would be administered as a slow intravenous (i.v.) bolus infusion. duration of investigational product (IP) administration would be 6 to 8 hours of single dose administration.
Intervention code [1] 285732 0
Treatment: Drugs
Comparator / control treatment
Normal saline solution
In each cohort, out of 8, 6 patients will receive Test product & 2 will receive placebo which is normal saline solution as per the randomization sheet generated by computerized software
Control group
Placebo

Outcomes
Primary outcome [1] 288014 0
To assess safety, A complete complete blood count (CBC) with platelets will be performed
Timepoint [1] 288014 0
at screening and Day 0 (upon admission to the clinical unit), and post-dose on Days 2, 3 and 7.
Primary outcome [2] 288056 0
Blood biochemistry testing (including amylase and lipase), and urinalysis with microscopic, will be performed
Timepoint [2] 288056 0
screening and Day 0 (admission), on Day 1 (6 hours post-infusion) and on Days 2, 3, 4, 5, and 7.
Primary outcome [3] 288057 0
Troponin I testing (cardiac assessment) will be performed
Timepoint [3] 288057 0
screening and Day 0 (admission), on Day 1 (baseline, 1, 3, and 6 hours post-infusion) and on Days 2, 3, 4, 5, and 7
Secondary outcome [1] 299286 0
To determine the plasma pharmacokinetic profile of
SANGUINATE in healthy volunteers
Serial blood samples for pharmacokinetic analysis will be collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours from the start of infusion. Plasma will be analyzed for concentrations of SANGUINATE using
a validated method
Timepoint [1] 299286 0
0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours from the start of infusion

Eligibility
Key inclusion criteria
1. Able to provide written Informed Consent
2. Male or female healthy volunteers
3. Age > 18 years and < 45 years;
4. Body Mass Index > 20 and < 30 kg/m2.
5. In good general health with no clinically significant illness seen on physical examination or ongoing medical history, as determined by the Investigator;
6. Documented 12-lead ECG with no clinically significant abnormalities, as determined by the Investigator
7. No clinically significant abnormalities in screening or Day 0 laboratory tests, as determined by the Investigator
8. Female subjects of reproductive potential must have a negative serum pregnancy (beta-HCG) test at screening and a negative urine pregnancy test at Day 0 prior to dosing. Female subjects must also be non-lactating
9. Adequate venous access and can receive intravenous infusions
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. If female, pregnant or lactating;
2. Any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, chronic hepatic disease or any other disease which in the judgment of the Investigator would interfere with the study or confound the results;
3. History of allergy or major allergic reaction considered to be clinically significant by the Investigator;
4. Screening or Day 0 clinical laboratory test result(s) determined to be clinically significant by the Investigator
5. Screening or Day 0 laboratory values for Troponin I > 0.31 ng/mL
6. Screening or Day 0 laboratory values for amylase or lipase > 1.1 x upper limit of normal
7. Physical examination or 12-lead ECG result(s) considered to be clinically significant by the Investigator
8. Donated blood within 60 days of screening or otherwise experienced blood loss of >250 mL within the same period;
9. Known to be allergic to any of the test product(s) or any components in the test product(s)
10. Intending to begin new concomitant drug therapy or over-the-counter medication anytime from screening to the time of administration of study drug
11. Received or intending to receive a vaccination in the two weeks prior to dosing, or anytime during study participation;
12. Received treatment with a drug that has not received regulatory approval for an indication during the 60 days preceding study enrollment
13. History of drug and/or alcohol dependence within past 12 months, and/or positive results on drug of abuse or alcohol tests
14. Screening laboratory result indicating HIV-positivity, or previously diagnosed with AIDS, AIDS related complex, or other immunodeficiency
15. Screening laboratory result indicating serologic positivity for hepatitis C antibodies or hepatitis B surface antigens, unless explained by a documented vaccination
16. Has taken any regular, prescribed, or over-the-counter medication with the exception of acetaminophen (maximum 2g/day), multi-vitamins, or hormonal birth control in the 2 weeks prior to dosing (other medication may only be taken with the specific approval of the Investigator in consultation
with the Medical Monitor)
17. Receiving any significant concomitant therapies
18. Malignancy within the last 5 years, with the exception of successfully treated basal cell carcinoma and carcinoma in situ uteri
19. Unable to comply with study attendance, protocol procedures or other study requirements
20. Any condition that, in the opinion of the investigator, might interfere with study objectives.

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)
This is a single-blind, placebo-controlled, single dose, safety and pharmacokinetic study of 3 ascending doses of SANGUINATE (trademark) in 3 cohorts of healthy volunteers. Twenty four (24) eligible healthy volunteers, ages 18 to 45, will be recruited and sequentially enrolled into one of 3 dosing cohorts, each consisting of no less than three males and no less than three females.
Within each cohort, two subjects will receive placebo (saline) and six subjects will receive active treatment.
Allocation to a particular arm would be done by central randomisation generated by computer software. Dose escalation to the next cohort will occur after review of the key safety data obtained from the previous cohort indicates that it is safe to proceed. Subjects in a given cohort will receive a single dose by intravenous infusion on the morning of Day 1, and be followed as an inpatient through at least 48-hours post-dose (Day 3), when they will be discharged and asked to return for follow-up visits on Days 4, 5, and 7 (+/-1 day)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5780 0
3004

Funding & Sponsors
Funding source category [1] 286033 0
Commercial sector/Industry
Name [1] 286033 0
Prolong Pharmaceuticals
Address [1] 286033 0
Prolong Pharmaceuticals
300 Corporate Court
South Plainfield, NJ 07080, USA
Country [1] 286033 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Prolong Pharmaceuticals
Address
Prolong Pharmaceuticals
300 Corporate Court
South Plainfield, NJ 07080, USA
Country
United States of America
Secondary sponsor category [1] 284845 0
Commercial sector/Industry
Name [1] 284845 0
Quintiles Australia
Address [1] 284845 0
Level 10 67 Albert Avenue, Chatswood, New South Wales, Australia 2067.
Country [1] 284845 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288080 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 288080 0
Alfred Hospital, Commercial Road, MELBOURNE, VIC 3004
Ethics committee country [1] 288080 0
Australia
Date submitted for ethics approval [1] 288080 0
24/09/2012
Approval date [1] 288080 0
21/11/2012
Ethics approval number [1] 288080 0
EC00315

Summary
Brief summary
Through local representative Quintiles, Prolong pharmaceuticals would like to conduct Phase I PK study in normal healthy volunteers for its investigational product - SANGUINATE at Nucleus Network, Alfred Hospital, Melbourne, Australia
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34736 0
Dr Jason lickliter
Address 34736 0
Nucleus Network Limited,
5th Floor, Burnet Tower, AMREP Precinct, 89 Commercial Road, Melbourne, VIC 3004, Australia
Country 34736 0
Australia
Phone 34736 0
+61 407 527 307
Fax 34736 0
Email 34736 0
j.lickliter@nucleusnetwork.com.au
Contact person for public queries
Name 17983 0
Mr Glenn Kazo
Address 17983 0
Prolong Pharmaceuticals, 300B Corporate Court, South Plainfield, NJ 07080, USA
Country 17983 0
United States of America
Phone 17983 0
+1-908-444-4651
Fax 17983 0
Email 17983 0
gkazo@prolongpharma.com
Contact person for scientific queries
Name 8911 0
Dr Dr. Abe Abuchowski
Address 8911 0
Prolong Pharmaceuticals
300 Corporate Court
South Plainfield, NJ 07080, USA
Country 8911 0
United States of America
Phone 8911 0
+1-908-444-4650
Fax 8911 0
+1 908-444-4661
Email 8911 0
aabuchowski@prolongpharma.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary