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Table 2 Geometric mean (95% CI) plasma PK of dezamizumab in Group 1a of the Phase 2 study (safety population)

From: Pharmacodynamic evaluation and safety assessment of treatment with antibodies to serum amyloid P component in patients with cardiac amyloidosis: an open-label Phase 2 study and an adjunctive immuno-PET imaging study

PK parameterb

Session 1 (n = 6)

Session 2 (n = 6)

Session 3 (n = 6)

Session 4 (n = 5)

Session 5 (n = 4)

Session 6 (n = 4)

AUC(0–t), h*μg/mL

5130 (3218, 8178)

14,610 (10,253, 20,820)

13,805 (8383, 22,732)

12,971 (7101, 23,692)

15,595 (7244, 33,574)

17,127 (8772, 33,440)

Cmax, µg/mL

86.94 (62.90, 120.16)

235.48 (181.46, 305.57)

222.23 (142.39, 346.83)

179.82 (119.43, 270.73)

185.52 (109.51, 314.31)

228.51 (108.15, 482.82)

Tmax, h

54.23 (53.88, 54.58)

53.95 (53.40, 54.50)

42.43 (22.27, 80.82)

54.74 (53.64, 55.87)

31.62 (5.47, 182.82)

54.56 (53.06, 56.11)

  1. aData from the one session in Group 2 were: AUC(0–t) 2148 h*µg/mL; Cmax 88.64 µg/mL; Tmax 6.07 h
  2. bAnti-SAP mAb was administered on Day 1 and Day 3 of the treatment session as a 300 mg dose on each day in session 1 and as a 600 mg dose on each day in subsequent sessions, with the exception of one patient from session 3 onwards where dose was split 300 mg:600 mg. The Group 2 patient received only one dose of 300 mg in the first session prior to treatment termination
  3. AUC(0–t), area under the concentration–time curve until the last measurable concentration; CI confidence interval, Cmax maximum concentration, PK pharmacokinetics, Tmax time to reach Cmax
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BMC Cardiovascular Disorders

ISSN: 1471-2261

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