Safety and Efficacy of POL6326 for Mobilization of Hematopoietic Stem Cells in Healthy Volunteers

Polyphor

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: POL6326

Study type: Interventional

Funder types: Industry

Identifiers

NCT01841476

POL-3

Details and patient eligibility

About

Phase I study to determine and compare the safety/tolerability of single ascending doses of POL6326 by intravenous infusion.

Full description

Phase I Study

• to determine and compare the safety of single ascending doses of POL6326 by intravenous infusion
• to determine the relationship between 2-hour single intravenous infusion doses of POL6326 and the concentration of HSC and mature WBC in peripheral blood using immunophenotypic assays.

Enrollment: 27 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Mobilization and collection of hematopoietic stem cells (HSCs) using G-CSF at least 6 weeks but less than 6 months prior to protocol enrollment.
2. Ages greater than or equal to 18 years and less than or equal to 55 years.
3. Normal liver and renal function, normal CBC, normal ECG, normal blood pressure including adequately medically controlled idiopathic arterial hypertension, no other contraindications to mobilized peripheral blood stem cell donation according to WMDA criteria and relevant SOPs at the study site defining additional exclusion criteria for stem cell donation.
4. Subject must be eligible for normal blood donation according to requirements for IDMs as laid out by national law for blood donors.
5. Ability to comprehend the investigational nature of the study and provide informed consent.

Exclusion criteria

1. Active infection or history of recurrent infection- hepatitis B and C (HBsAg, Anti-HBc, Anti-HCV), HIV and HTLV-1.
2. History of autoimmune disease such as rheumatoid arthritis, systemic lupus erythematous.
3. History of cancer within the past 5 years excluding basal cell or squamous cell carcinoma of the skin.
4. History of any hematologic disorders including thromboembolic disease.
5. History of cardiac disease such as uncontrolled hypertension, peripheral vascular disease, myocardial infarction, cardiac arrhythmias OR related symptoms such as tachycardia, chest pain, shortness of breath which have required medical intervention OR treatment or a Framingham coronary disease risk prediction score of greater than 10% 10 year coronary heart disease (CHD) risk.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

POL6326

Experimental group

Description:

2-hour single intravenous infusion doses of POL6326

Treatment:

Drug: POL6326