HealthyPhase 1NCT01841476
Safety and Efficacy of POL6326 for Mobilization of Hematopoietic Stem Cells in Healthy Volunteers
A Phase 1 study testing POL6326 in people with Healthy, run by Polyphor Ltd. at 1 site in Germany.
Trial summary
Phase I study to determine and compare the safety/tolerability of single ascending doses of POL6326 by intravenous infusion. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- POL6326
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2012to Sep 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
German Red Cross Blood Service and Institute for Transfusion Medicine and Immunohematology of the Goethe University
Frankfurt, 60590
About this study
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
Phase I study to determine and compare the safety/tolerability of single ascending doses of POL6326 by intravenous infusion.
Read the 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.
- Conditions
- Healthy
- Being tested
- POL6326
- Keywords
- Peripheral blood, HSC, Mobilization, CXCR4, volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POL6326Drug
| Study group | Role | What they receive |
|---|---|---|
| POL6326 | Experimental | 2-hour single intravenous infusion doses of POL6326 Receives: Drug: POL6326 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days
Secondary outcomes (2)
Pharmacokinetic outcome
Determine the pharmacokinetic profile of POL6326 following single intravenous administration, e.g. Cmax, AUC, terminal half life and clearance
Measured: 24h
Mobilisation of CD34+ cells
Time dependent measurement of CD34+ cells during and after infusion of POL6326 in all subjects
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startFeb 2012
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polyphor Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Halvard Boenig, M.D. Ph.D, Principal investigator, German Red Cross Blood Service and Institute for Transfusion Medicine and Immunohematology of the Goethe University, Frankfurt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841476
- Sponsor's protocol ID
- POL-3
- Status last verified
- Nov 2015
- First submitted
- 2 Apr 2013
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28049490
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01841476
- Acronym / sponsor ID
- POL-3
- Conditions
- Healthy
- Keywords
- Peripheral blood, HSC, Mobilization, CXCR4, volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Polyphor Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 26 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I study to determine and compare the safety/tolerability of single ascending doses of POL6326 by intravenous infusion.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POL6326 | Experimental | Drug: POL63262-hour single intravenous infusion doses of POL6326 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POL6326 | Drug | POL6326 |
Primary outcome
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.
2 secondary outcomes
Pharmacokinetic outcome
Time frame: 24h
Mobilisation of CD34+ cells
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
- Derived from this study: PubMed 28049490Karpova 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Halvard Boenig, M.D. Ph.D principal investigator
German Red Cross Blood Service and Institute for Transfusion Medicine and Immunohematology of the Goethe University, Frankfurt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing POL6326 in people with Healthy, run by Polyphor Ltd. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of single ascending doses of POL6326 by intravenous infusion according to standard criteria (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01841476, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2015.