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

Sponsor

Polyphor Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT01841476

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

N/A

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 :

Feb 1, 2012

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: POL6326

2-hour single intravenous infusion doses of POL6326

Drug: POL6326

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

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