None listed
Conditions
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
Interventions
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
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.
Sponsors
Prolong Pharmaceuticals
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
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.
Outcome results
None listed