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

Safety assessment of SANGUINATE™ in Healthy Volunteers.

Study Overview

• Status: Terminated
• Conditions: Drug Safety
• Intervention / Treatment: Biological: SANGUINATE™; Drug: Normal Saline Solution

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 1

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Health Care Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SANGUINATE™; PEG-bHb-CO	Biological: SANGUINATE™; PEG-bHb-CO; Other Names: PEG-bHb-CO
Placebo Comparator: Normal Saline Solution; Saline Solution	Drug: Normal Saline Solution; Placebo; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events as a measure of safety and tolerability.	Adverse events of SANGUINATE™	7 days

Collaborators and Investigators

• Sponsor: Prolong Pharmaceuticals
• Investigators: Principal Investigator: Benjamin Brenner, MD, Rambam Health Care Facility

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: April 23, 2013
• First Submitted That Met QC Criteria: May 1, 2013
• First Posted (Estimate): May 6, 2013

Study Record Updates

• Last Update Posted (Estimate): January 6, 2015
• Last Update Submitted That Met QC Criteria: January 5, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: SGHV-005