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

Drug Safety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01847222
• Other study ID #: SGHV-005
• Status: Terminated
• Phase: Phase 1
• First received: April 23, 2013
• Last updated: January 5, 2015
• Start date: May 2013
• Est. completion date: August 2014

Study information

• Verified date: January 2015
• Source: Prolong Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Safety assessment of SANGUINATE™ in Healthy Volunteers.

Description:

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

Recruitment information / eligibility

• 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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Drug Safety

Intervention

Biological:
• SANGUINATE™
PEG-bHb-CO

Drug:
• Normal Saline Solution
Placebo

Locations

Country	Name	City	State
Israel	Rambam Health Care Facility	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Prolong Pharmaceuticals

Country where clinical trial is conducted

Israel, 

Outcome

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