Status:
TERMINATED
An Assessment of the Safety and Pharmacokinetics of Ascending Doses of SANGUINATE™ in Healthy Volunteers.
Lead Sponsor:
Prolong Pharmaceuticals
Conditions:
Drug Safety
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
Safety assessment of SANGUINATE™ in Healthy Volunteers.
Detailed Description
Safety and Pharmacokinetic assessment in ascending doses of SANGUINATE™ in Healthy Volunteers.
Eligibility Criteria
Inclusion
- Male Volunteers;
- Age ≥18 years and ≤45 years;
- BMI ≥20- ≤30 kg/m²
- No clinically significant screening observations
Exclusion
- Female volunteers;
- 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;
- History of allergy or major allergic reactions considered to be clinically significant by the Investigator;
- Any screening assessment determined to be clinically significant by the Investigator;
- Donate blood within 60 days of screening or otherwise experienced blood loss \>250 mL within the same period;
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01847222
Start Date
May 1 2013
End Date
August 1 2014
Last Update
January 6 2015
Active Locations (1)
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1
Rambam Health Care Facility
Haifa, Israel