Table 3.

PD Response Summary of IGF-I to a Single Dose Administration of VRS-317 in the PK/PD Population (n = 48)

Dose	No.	Stability, ng/mL	Baseline, ng/mL	Cmax, ng/mL	Cmax (SDS)	Tmax, d	AUC0–t, ng·h/mL	Average, ng/mL
Placebo	9	188 ± 49	106 ± 47	ND	ND	ND	ND	102 ± 49
0.05 mg/kg	8	212 ± 41	97 ± 47	137 ± 58	−1.1 ± 0.7	6.4 ± 6.5	2837 ± 1330	95 ± 44
0.10 mg/kg	8	170 ± 30	57 ± 18	105 ± 43	−1.2 ± 0.9	5.0 ± 2.9	2214 ± 855	74 ± 29
0.20 mg/kg	8	214 ± 68	86 ± 30	196 ± 58	−0.5 ± 0.9	4.1 ± 1.8	3541 ± 1260	118 ± 42
0.40 mg/kg	8	165 ± 44	70 ± 40	248 ± 87	0.9 ± 1.4	4.5 ± 1.4	3771 ± 1524	126 ± 51
0.80 mg/kg	7	197 ± 76	89 ± 31	280 ± 103	1.4 ± 1.3	5.1 ± 2.0	4884 ± 915	163 ± 31

Stability refers to the time during which daily rhGH treatment was given. Baseline refers to day 1, before the dose of VRS-317 or placebo. The IGF-I AUC was calculated using the linear trapezoid rule. Average IGF-I was calculated by dividing AUC by the observation interval of 29 days. The dose proportionality correlation coefficients (log:log) were 0.76 for baseline corrected C_max and 0.76 for baseline corrected AUC_0–t.

Abbreviations: AUC_0–t, area under the curve from time zero to the last measurable time point; C_max, maximum concentration; ND, not determined; T_max, time to maximum concentration.