Not provided
Not provided
Not provided
Not provided
Not provided
Terminated due to completion of competing study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Safety assessment of SANGUINATEâ„¢ in Healthy Volunteers.
Safety and Pharmacokinetic assessment in ascending doses of SANGUINATEâ„¢ in Healthy Volunteers.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SANGUINATEâ„¢ | Experimental | PEG-bHb-CO |
|
| Normal Saline Solution | Placebo Comparator | Saline Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SANGUINATEâ„¢ | Biological | PEG-bHb-CO |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability. | Adverse events of SANGUINATEâ„¢ | 7 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Benjamin Brenner, MD | Rambam Health Care Facility | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Health Care Facility | Haifa | Israel |
Not provided
| ID | Term |
|---|---|
| C000633826 | PEGylated carboxyhemoglobin bovine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Normal Saline Solution | Drug | Placebo |
|
|