An assessment of the safety and pharmacokinetic of ascending doses of sanguinate (Trademark) in healthy volunteers
- Conditions
- Effect of the drug Sanguinate on healthy volunteersOther - Research that is not of generic health relevance and not applicable to specific health categories listed above
- Registration Number
- ACTRN12612001033831
- Lead Sponsor
- Prolong Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
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
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method