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Trial · Interventional

CompletedPhase 1Registry data

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

Overview

Status
Completed
Phase
Phase 1
Enrollment
27 participants (actual)
Sponsor
Polyphor Ltd. · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Germany

Start
Feb 2012
Primary completion
Aug 2015
Completion
Sept 2015
First posted
26 Apr 2013 (estimated)
Last update posted
25 Nov 2015 (estimated)
Conditions
Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20122013201420152016
  1. Ph 1

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

    NCT01841476

    Feb 2012 to Sept 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • POL6326Drug

Arms1

  • Experimental

    POL6326

    2-hour single intravenous infusion doses of POL6326

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Safety of single ascending doses of POL6326 by intravenous infusion according to standard criteria

    Time frame · 2 days

    Registry description

    Safety as measured by the incidence, type and severity of adverse events.

Secondary outcomes(2)
  1. Pharmacokinetic outcome

    Time frame · 24h

    Registry description

    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

    Registry description

    Time dependent measurement of CD34+ cells during and after infusion of POL6326 in all subjects

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2017

9 results

Mobilization of hematopoietic stem cells with the novel CXCR4 antagonist POL6326 (balixafortide) in healthy volunteers-results of a dose escalation trial.

Karpova et al. 2017Journal of translational medicinecited by 42

PMID 28049490PMC5209880DOI 10.1186/s12967-016-1107-2PUB-28049490

CC BY9 results

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 55 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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