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

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ClinicalTrials.gov Identifier: NCT01841476
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : November 25, 2015
Sponsor:
Information provided by (Responsible Party):
Polyphor Ltd.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: POL6326 Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

Arm Intervention/treatment
Experimental: POL6326
2-hour single intravenous infusion doses of POL6326
Drug: POL6326



Primary Outcome Measures :
  1. Safety of single ascending doses of POL6326 by intravenous infusion according to standard criteria [ Time Frame: 2 days ]
    Safety as measured by the incidence, type and severity of adverse events.


Secondary Outcome Measures :
  1. Pharmacokinetic outcome [ Time Frame: 24h ]
    Determine the pharmacokinetic profile of POL6326 following single intravenous administration, e.g. Cmax, AUC, terminal half life and clearance

  2. Mobilisation of CD34+ cells [ Time Frame: 2 days ]
    Time dependent measurement of CD34+ cells during and after infusion of POL6326 in all subjects



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841476


Locations
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Germany
German Red Cross Blood Service and Institute for Transfusion Medicine and Immunohematology of the Goethe University
Frankfurt, Germany, 60590
Sponsors and Collaborators
Polyphor Ltd.
Investigators
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Principal Investigator: Halvard Boenig, M.D. Ph.D German Red Cross Blood Service and Institute for Transfusion Medicine and Immunohematology of the Goethe University, Frankfurt, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Polyphor Ltd.
ClinicalTrials.gov Identifier: NCT01841476     History of Changes
Other Study ID Numbers: POL-3
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: November 25, 2015
Last Verified: November 2015
Keywords provided by Polyphor Ltd.:
Peripheral blood
HSC
Mobilization
CXCR4
volunteers