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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