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

NCT01841476 | Completed Phase 1 DMC

• 1 other identifier: POL-3
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Peripheral blood; HSC; Mobilization; CXCR4; volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pharmacokinetic outcome

  24h

• Mobilisation of CD34+ cells

  2 days

Study Arms (1)

POL6326

EXPERIMENTAL

2-hour single intravenous infusion doses of POL6326

Drug: POL6326

Interventions

POL6326 DRUG

POL6326

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Polyphor Ltd.: lead

Study Sites (1)

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

Frankfurt, 60590, Germany

Location

Related Publications (1)

• 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.

  PMID: 28049490 DERIVED

MeSH Terms

Interventions

balixafortide

Study Officials

• Halvard Boenig, M.D. Ph.D

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: April 26, 2013
• Study Start: February 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 25, 2015

Record last verified: 2015-11

Locations

DE (1)