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

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

Detailed Description
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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.

Official Title
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POL6326 - A Phase I, Open, Single Intravenous Infusion Dose, Pharmacokinetic and Pharmacodynamic Study in Healthy Volunteers Who Are Volunteering as Haematopoietic Stem Cell (HSC) Donors

Conditions
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Healthy

Intervention / Treatment
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* Drug: POL6326


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mobilization and collection of hematopoietic stem cells (HSCs) using G-CSF at least 6 weeks but less than 6 months prior to protocol enrollment. Ages greater than or equal to 18 years and less than or equal to 55 years. 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. Subject must be eligible for normal blood donation according to requirements for IDMs as laid out by national law for blood donors. Ability to comprehend the investigational nature of the study and provide informed consent. Exclusion Criteria: Active infection or history of recurrent infection- hepatitis B and C (HBsAg, Anti-HBc, Anti-HCV), HIV and HTLV-1. History of autoimmune disease such as rheumatoid arthritis, systemic lupus erythematous. History of cancer within the past 5 years excluding basal cell or squamous cell carcinoma of the skin. History of any hematologic disorders including thromboembolic disease. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: POL6326<br>2-hour single intravenous infusion doses of POL6326 | Drug: POL6326<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of single ascending doses of POL6326 by intravenous infusion according to standard criteria | Safety as measured by the incidence, type and severity of adverse events. | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic outcome | Determine the pharmacokinetic profile of POL6326 following single intravenous administration, e.g. Cmax, AUC, terminal half life and clearance | 24h | 
| Mobilisation of CD34+ cells | Time dependent measurement of CD34+ cells during and after infusion of POL6326 in all subjects | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral blood, HSC, Mobilization, CXCR4, volunteers