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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01841476

Enrollment

Registered

2013-04-26

Start date

2012-02-29

Completion date

2015-09-30

Last updated

2015-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Peripheral blood, HSC, Mobilization, CXCR4, volunteers

Brief summary

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.

Interventions

DRUGPOL6326

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026