NCT01847222

Brief Summary

Safety assessment of SANGUINATE™ in Healthy Volunteers.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2013

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

January 6, 2015

Status Verified

January 1, 2015

Enrollment Period

1 year

First QC Date

April 23, 2013

Last Update Submit

January 5, 2015

Conditions

Drug Safety

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events as a measure of safety and tolerability.

    Adverse events of SANGUINATE™

    7 days

Study Arms (2)

SANGUINATE™

EXPERIMENTAL

PEG-bHb-CO

Biological: SANGUINATE™

Normal Saline Solution

PLACEBO COMPARATOR

Saline Solution

Drug: Normal Saline Solution

Interventions

SANGUINATE™BIOLOGICAL

PEG-bHb-CO

Also known as: PEG-bHb-CO
SANGUINATE™
Normal Saline SolutionDRUG

Placebo

Also known as: Placebo
Normal Saline Solution

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male Volunteers;
  • Age ≥18 years and ≤45 years;
  • BMI ≥20- ≤30 kg/m²
  • No clinically significant screening observations

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Facility

Haifa, Israel

Location

MeSH Terms

Interventions

PEGylated carboxyhemoglobin bovineSaline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Benjamin Brenner, MD

    Rambam Health Care Facility

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2013

First Posted

May 6, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2014

Study Completion

August 1, 2014

Last Updated

January 6, 2015

Record last verified: 2015-01

Locations

IL(1)