Drug Safety Clinical Trial
Official title:
An Assessment of the Safety and Pharmacokinetics of Ascending Doses of SANGUINATE™ in Healthy Volunteers.
Verified date | January 2015 |
Source | Prolong Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Interventional |
Safety assessment of SANGUINATE™ in Healthy Volunteers.
Status | Terminated |
Enrollment | 2 |
Est. completion date | August 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Male Volunteers; - Age =18 years and =45 years; - BMI =20- =30 kg/m² - No clinically significant screening observations Exclusion Criteria: - 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; |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Israel | Rambam Health Care Facility | Haifa |
Lead Sponsor | Collaborator |
---|---|
Prolong Pharmaceuticals |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with adverse events as a measure of safety and tolerability. | Adverse events of SANGUINATE™ | 7 days | Yes |
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