Skip to main content

Table 1 Study design

From: Mobilization of hematopoietic stem cells with the novel CXCR4 antagonist POL6326 (balixafortide) in healthy volunteers—results of a dose escalation trial

  1st treatment
Dose (μg/kg)/infusion time (h)/infusion rate
2nd treatment
Dose (μg/kg)/infusion time (h)/infusion rate
Group 1
 Volunteer 1 500/2/constant _
 Volunteer 2 500/2/constant
 Volunteer 3 500/2/constant
Group 2
 Volunteer 1 1000/2/constant 2500/2/constant H
 Volunteer 2 1000/2/constant 2500/2/constant H
 Volunteer 3 1000/2/constant
 Volunteer 4 1000/2/constant 2500/2/constant H
Group 3
 Volunteer 1 1000/1/constant h 1000/2/const. rate
 Volunteer 2 1000/1/constant 1000/2/const. rate
 Volunteer-3 1000/1/constant 1000/2/const. rate
Group 4
 Volunteer 1 1500/2/constant 2500/2/const. rate H
 Volunteer 2 1500/2/constant h 2500/2/const. rate H
 Volunteer 3 1500/2/constant
 Volunteer 4 1500/2/constant 2500/2/const. rate H
Group 5
 Volunteer 1 2000/2/constant h
 Volunteer 2 2000/2/constant
 Volunteer 3 2000/2/constant h
 Volunteer 4 2000/2/constant h
 Volunteer 5 2000/2/constant h
 Volunteer 6 2000/2/constant h
Group 6
 Volunteer 1 2000/2/ramped
 Volunteer 2 2000/2/ramped h
 Volunteer 3 2000/2/ramped
Group 7
 Volunteer 1 2500/2/constant H
 Volunteer 2 2500/2/constantH 1500/2/const. rate
 Volunteer 3 2500/2/constantH 1500/2/const. rate
 Volunteer 4 2500/2/constantH 1500/2/const. rate
  1. A total of 27 volunteers were treated with 39 doses of balixafortide
  2. In italics volunteers with histamine release associated AE
  3. HAnti-histamine premedication
  4. h Therapeutic anti-histamine treatment upon appearance of likely histamine release AEs