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

NCT ID: NCT01841476

Last Updated: 2015-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-09-30

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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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POL6326

2-hour single intravenous infusion doses of POL6326

Group Type EXPERIMENTAL

POL6326

Intervention Type DRUG

Interventions

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POL6326

Intervention Type DRUG

Eligibility Criteria

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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.

Exclusion Criteria

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.


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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Polyphor Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Halvard Boenig, M.D. Ph.D

Role: PRINCIPAL_INVESTIGATOR

German Red Cross Blood Service and Institute for Transfusion Medicine and Immunohematology of the Goethe University, Frankfurt, Germany

Locations

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German Red Cross Blood Service and Institute for Transfusion Medicine and Immunohematology of the Goethe University

Frankfurt, , Germany

Site Status

Countries

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Germany

References

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Karpova D, Brauninger S, Wiercinska E, Kramer A, Stock B, Graff J, Martin H, Wach A, Escot C, Douglas G, Romagnoli B, Chevalier E, Dembowski K, Hooftman L, Bonig H. Mobilization of hematopoietic stem cells with the novel CXCR4 antagonist POL6326 (balixafortide) in healthy volunteers-results of a dose escalation trial. J Transl Med. 2017 Jan 3;15(1):2. doi: 10.1186/s12967-016-1107-2.

Reference Type DERIVED
PMID: 28049490 (View on PubMed)

Other Identifiers

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POL-3

Identifier Type: -

Identifier Source: org_study_id