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Table 4 Geometric mean (CV) of serum AL002 PK parameters in the phase 1 study

From: Preclinical and first-in-human evaluation of AL002, a novel TREM2 agonistic antibody for Alzheimer’s disease

 

AL002a

Parameter

0.6 mg/kg

(n = 6)

2 mg/kg

(n = 6)

6 mg/kg

(n = 6)

15 mg/kg

(n = 6)

30 mg/kg

(n = 6)

45 mg/kg

(n = 6)

60 mg/kg

(n = 14)

AUC0 − t, hµg/mL

1280

(27.0)

5400

(16.4)

16,300

(13.6)

48,200

(6.8)

80,100

(24.3)

95,000

(129.1)

138,000

(31.9)

AUC0 − inf, hµg/mL

1280

(27.0)

5430

(16.6)

16,400

(13.6)

48,200

(7.0)

80,200

(24.3)

95,200

(129.0)

138,000

(31.0)

Cmax, µg/mL

15.1

(23.5)

60.6

(26.0)

147

(11.2)

430

(24.5)

722

(10.8)

831

(138.6)

1530

(30.3)

tmax, hb

5.09

(1.18, 9.30)

1.32

(1.18, 13.0)

1.18

(1.17, 1.38)

5.09

(1.20, 13.1)

1.32

(1.17, 9.00)

1.52

(1.17, 4.63)

1.31

(1.12, 25.0)

t½, hc

121

(16.0)

167

(25.2)

195

(11.3)

216

(27.7)

196

(24.2)

201

(33.0)

191

(28.2)

CL, mL/h

29.9

(25.5)

27.5

(25.0)

26.3

(14.7)

22.6

(10.0)

24.5

(25.3)

28.1

(39.9)

30.2

(23.6)

Vz, L

5.17

(12.3)

6.45

(17.9)

7.35

(14.6)

6.75

(39.5)

6.78

(32.4)

7.80

(23.8)

7.98

(39.5)

  1. Mean exposure levels and half-life values increased with increasing doses of AL002
  2. aData from single-participant dose groups (0.003-0.2 mg/kg) are not shown
  3. bFor tmax, the median (minimum, maximum) values are presented
  4. cFor t1/2, the mean (CV) values are presented
  5. AUC, area under the concentration-time curve; CL, clearance; Cmax, maximum concentration; NA, not available; PK, pharmacokinetics; t½, half life; Tmax, time to reach Cmax; Vz, apparent total volume of distribution at the terminal phase