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Table 4 Frequency of Antidrug Antibody Activity

From: A phase 1, randomized, open-label, single-dose study to assess the relative bioavailability of a subcutaneous dose of FKB327 when administered using a prefilled syringe, a prefilled auto-injector, or a vial with disposable syringe in healthy subjects

Time point (h)

FKB327 vial

n = 66

n (%)

FKB327 PFS

n = 63

n (%)

FKB327 AI

n = 66

n (%)

Negative

Positive

Negative

Positive

Negative

Positive

Predose

52 (78.8)

14 (21.2)

51 (81.0)

12 (19.0)

59 (89.4)

7 (10.6)

360

13 (19.7)

52 (78.8)

29 (46.0)

34 (54.0)

25 (37.9)

41 (62.1)

696

4 (6.1)

61 (92.4)

4 (6.3)

59 (93.7)

4 (6.1)

62 (93.9)

1536

0

66 (100)a

0

63 (100)

1 (1.5)

65 (98.5)

  1. aIncludes 1 early-withdrawal subject
  2. AI indicates prefilled autoinjector; PFS prefilled syringe; vial, vial with disposable syringe
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BMC Pharmacology and Toxicology

ISSN: 2050-6511

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