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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01847222

Enrollment

Registered

2013-05-06

Start date

2013-05-31

Completion date

2014-08-31

Last updated

2015-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Safety

Brief summary

Safety assessment of SANGUINATE™ in Healthy Volunteers.

Detailed description

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

Interventions

BIOLOGICALSANGUINATE™

PEG-bHb-CO

DRUGNormal Saline Solution

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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;

Design outcomes

Primary

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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026