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An Assessment of the Safety and Pharmacokinetics of Ascending Doses of SANGUINATE™ in Healthy Volunteers.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01847222
Recruitment Status : Terminated (Terminated due to completion of competing study.)
First Posted : May 6, 2013
Last Update Posted : January 6, 2015
Sponsor:
Information provided by (Responsible Party):
Prolong Pharmaceuticals

Brief Summary:
Safety assessment of SANGUINATE™ in Healthy Volunteers.

Condition or disease Intervention/treatment Phase
Drug Safety Biological: SANGUINATE™ Drug: Normal Saline Solution Phase 1

Detailed Description:
Safety and Pharmacokinetic assessment in ascending doses of SANGUINATE™ in Healthy Volunteers.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: An Assessment of the Safety and Pharmacokinetics of Ascending Doses of SANGUINATE™ in Healthy Volunteers.
Study Start Date : May 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arm Intervention/treatment
Experimental: SANGUINATE™
PEG-bHb-CO
Biological: SANGUINATE™
PEG-bHb-CO
Other Name: PEG-bHb-CO

Placebo Comparator: Normal Saline Solution
Saline Solution
Drug: Normal Saline Solution
Placebo
Other Name: Placebo




Primary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability. [ Time Frame: 7 days ]
    Adverse events of SANGUINATE™



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01847222


Locations
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Israel
Rambam Health Care Facility
Haifa, Israel
Sponsors and Collaborators
Prolong Pharmaceuticals
Investigators
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Principal Investigator: Benjamin Brenner, MD Rambam Health Care Facility
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Responsible Party: Prolong Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01847222    
Other Study ID Numbers: SGHV-005
First Posted: May 6, 2013    Key Record Dates
Last Update Posted: January 6, 2015
Last Verified: January 2015