A randomised, open-label, placebo-controlled, single centre study in healthy male volunteers to explore efficacy, safety and tolerability of single doses of low molecular weight dextran sulfate (LMW-DS) in combination with recombinant human granulocyte colony stimulating factor (rhG-CSF, filgrastim) and in comparison with plerixafor treatment and placebo

TikoMed AB0 个研究点开始时间: 2014年3月27日最近更新: 2015年3月30日

试验速览

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•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

•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

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