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

Prolong Pharmaceuticals

Status and phase: Terminated; Phase 1

Conditions: Drug Safety

Treatments: Drug: Normal Saline Solution; Biological: SANGUINATE™

Study type: Interventional

Funder types: Industry

Identifiers

NCT01847222

SGHV-005

Details and patient eligibility

About

Safety assessment of SANGUINATE™ in Healthy Volunteers.

Full description

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

Enrollment: 2 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups, including a placebo group

SANGUINATE™

Experimental group

Description:

PEG-bHb-CO

Treatment:

Biological: SANGUINATE™

Normal Saline Solution

Placebo Comparator group

Description:

Saline Solution

Treatment:

Drug: Normal Saline Solution