Healthy volunteers (mobilization of haematopoietic stem cells) MedDRA version: 17.0 Level: LLT Classification code 10053948 Term: Hematopoietic stem cell mobilization System Organ Class: 100000004865
Conditions
Interventions
Product Name: LMW-DS solution
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: -
CAS Number: 9011-18-1
Current Sponsor code: DSSS5
Other descriptive name: DEXTRAN SULFATE SODIUM
Concent
Sponsors
TikoMed AB
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Male subjects, 18 to 50 years of age, at the time of informed consent 2) Body Weight =60 to =95 kg 3) Signed Informed Consent 4) Healthy according to medical history including bleeding tendency for the participant or first degree family members. Laboratory analyses for PK(INR), fibrinogen, Von Willebrand´s factor and APTT must be within normal range at screening. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Any medication including herbal remedies and over the counter (OTC) drugs (except for paracetamol) within 14 days prior to study drug administration 2) Positive urine drug screen and alcohol breath test 3) Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), human immunodeficiency virus (HIV) antibody/antigen, at Screening. 4) Intake of any other study medication within 90 days prior to screening 5) Blood or plasma donation/loss of more than 400 mL within 90 days prior to study drug administration 6) Clinically significant deviations from normal values for vital signs, ECG and laboratory tests. 7) Current nicotine user 8) Evidence of clinically significant orthostatic symptoms (eg, dizziness upon standing) or systolic BP drop =20 mm Hg or diastolic BP drop =10 mm Hg from supine to standing assessment at screening. An increase in pulse of >30 beats per minute (bpm) or an increase in pulse >120 bpm from supine to standing at screening. 9) Allergy at the discretion of the investigator 10) Any condition that, in the Investigator’s opinion, may interfere with a subject’s ability to comply with the study protocol 11) Any other condition which, in the Investigator’s opinion, would make the subject unsuitable for inclusion into the trial
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): None;Timepoint(s) of evaluation of this end point: N/A | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the blood levels of CD34+ cells at different time points after treatment with filgrastim (for 5 days) in combination with low molecular weight dextran sulfate (LMW-DS) compared to filgrastim treatment (for 5 days) in combination with plerixafor or NaCl.;Secondary Objective: • to evaluate safety and tolerability • to measure WBCs and lymphocytes • to measure the levels of HGF • to measure the levels of SDF-1 • to measure the effect on APTT ;Primary end point(s): Absolute number, fold increase, peak fold change compared to pre-dose values and area under the curve (AUC) of circulating CD34+ cells for all treatment groups will be assessed on Day 5 (cells are counted over 24 hours after LMW-DS/plerixafor/NaCl treatment) ;Timepoint(s) of evaluation of this end point: CD34+ will be assessed 30 minutes before start of LMW-DS infusion/plerixafor injection/NaCl infusion (Day 5) and at 1, 3, 6, 9 and 24 h post start of LMW-DS infusion/plerixafor injektion/NaCl infusion. | — |
Countries
Sweden
Contacts
Public ContactLinn Skärberg
PCG Clinical Services AB
Outcome results
None listed