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. 2016 Nov 17;10(1):3–11. doi: 10.1111/cts.12430

Table 2.

Pharmacokinetic parameters following single doses of RN317 or bococizumab in subjects with hypercholesterolemia receiving ongoing statin therapy

RN317 Bococizumab
s.c. s.c. s.c. s.c. i.v. i.v. i.v. s.c. s.c. i.v.
0.3 mg/kg 1 mg/kg 3 mg/kg 6 mg/kg 1 mg/kg 3 mg/kg 6 mg/kg 1 mg/kg 3 mg/kg 1 mg/kg
(n = 6) (n = 12) (n = 16) (n = 6) (n = 11) (n = 6) (n = 6) (n = 12) (n = 16) (n = 6)
n * 6 12 16 6 11 6 6 12 16 6
Cmax, μg/ml 1.172 3.099 11.09 23.02 35.7 86.01 157.8 1.824 11.85 35.89
(20) (33) (35) (28) (195) (12) (9) (65) (66) (12)
Tmax, h 253 253 120 72 2.0 2.51 2.00 156 72.0 1.50
(143–339) (72–504) (24–672) (72–337) (0.967–4.00) (1.00–4.00) (1.00–3.00) (48.0–171) (4.00–168) (1.00–4.00)
N* 2 8 16 6 11 6 6 1 10 6
AUCinf, μg.h/ml NR 3,103 7,995 18,100 6,705 19,420 29,220 NR 3,721 3,451
(30) (32) (30) (22) (13) (6) (47) (13)
t1/2, days NR 20.88 ± 4.33 19.40 ± 5.40 18.58 ± 4.1 19.49 ± 6.43 17.52 ± 2.9 14.63 ± 4.68 NR 8.378 ± 2.656 3.400 ± 0.692

Data shown are geometric mean (coefficient of variation; %CV) for all parameters except for Tmax where median (min, max) is shown, and t1/2 where arithmetic mean ± SD is shown.

*n is the number of subjects in the treatment group and contributing to the mean; N is the number of subjects with a well‐characterized terminal phase. AUCinf, area under the plasma concentration–time curve from time zero to infinity; Cmax, maximum concentration; NR, not reported where <3 subjects had reportable parameter values; SD, standard deviation; t1/2, terminal half‐life; Tmax, time to reach maximum concentration.