Table 4.

Summary of Plasma PK Parameters of ELX‐02 on Days 1 and 29

	ELX‐02 Dose
Parameter	Statistics	0.1 mg/kg (N = 6)	0.3 mg/kg (N = 5)	1.0 mg/kg (N = 12)	2.5 mg/kg (N = 12)	5.0 mg/kg (N = 6)
Day 1
Cmax, ng/mL	Mean	290	1005	2898	7736	16099
	SD	60	58	338	512	2566
tmax, h	Median	1.17	0.75	0.92	0.90	0.86
	Min, Max	0.50, 3.00	0.50, 1.00	0.75, 1.00	0.75, 1.00	0.73, 1.00
AUCt, ng • h/mL	Mean	1074	3083	10942	28545	63147
	SD	184	409	1477	4611	13356
AUC24h, ng • h/mL	Mean	1115	3150	11097	28569	62994
	SD	170	452	1412	4489	13127
AUC48h, ng • h/mL	Mean	1118	3152	11117	28676	63254
	SD	171	454	1438	4564	13343
AUC72h, ng • h/mL	Mean	1118	3152	11118	28677	63260
	SD	171	454	1439	4566	13349
AUCinf, ng • h/mL	Mean	1118	3153	11118	28679	63262
	SD	171	455	1439	4566	13351
C1h, ng/mL	Mean	264	918	2822	7511	15132
	SD	52	61	252	539	2454
t1/2, h	Mean	2.31	2.06	2.32	2.87	2.96
	SD	0.61	0.23	0.51	0.52	0.48
Vd/F, L	Mean	23.38	17.57	22.27	25.04	26.42
	SD	4.72	1.74	3.38	3.01	4.66
CL/F, L/h	Mean	7.14	5.93	6.79	6.24	6.25
	SD	1.10	0.53	1.02	1.30	1.06
Day 29
Cmax, ng/mL	Mean	345	964	2840	7908	15533
	SD	42	73	436	1010	2091
tmax, h	Median	0.80	0.80	0.93	0.86	0.90
	Min, Max	0.50, 1.00	0.75, 1.00	0.75, 1.00	0.75, 1.00	0.73, 0.98
AUCt, ng • h/mL	Mean	1163	3046	10748	30388	55206
	SD	201	483	1607	7277	7947
AUC24h, ng • h/mL	Mean	1226	3145	10947	30381	55100
	SD	182	542	1578	7148	7770
AUC72h, ng • h/mL	Mean	1228	3150	10964	30524	55295
	SD	183	546	1597	7252	7919
AUCinf, ng • h/mL	Mean	1228	3150	10964	30526	55296
	SD	183	546	1597	7253	7920
C1h, ng/mL	Mean	333	900	2780	7594	14652
	SD	31	50	407	1020	3560
t1/2, h	Mean	2.09	2.39	2.29	2.99	3.00
	SD	0.51	0.25	0.48	0.67	0.59
Vd/F, L	Mean	19.98	20.38	22.09	25.22	33.66
	SD	5.07	1.27	4.01	4.67	5.69
CL/F, L/h	Mean	6.67	5.95	6.80	6.07	7.51
	SD	1.34	0.58	1.17	1.47	0.89
Rac(AUC24h)	Mean	1.09	0.99	0.99	1.07	0.92
	SD	0.08	0.06	0.08	0.15	0.13
Rac(Cmax)	Mean	1.23	0.96	0.98	1.03	0.94
	SD	0.18	0.07	0.2	0.16	0.01

AUC_24h, area under the plasma concentration–time curve from time zero to 24 hours; AUC_48h, area under the plasma concentration–time curve from time zero to 48 hours; AUC_72h, area under the plasma concentration–time curve from time zero to 72 hours; AUC_inf, area under the plasma concentration–time curve from time zero to infinity; AUC_t, area under the plasma concentration–time curve over the dosing interval; C_1h, 1‐hour postdose concentration; C_max, maximum plasma concentration; CL/F, apparent clearance; PK, pharmacokinetic; R_ac, accumulation ratio; t_1/2, elimination half‐life; t_max, time to maximum concentration; V_d/F, apparent volume of distribution.

Any values below the limit of quantitation were set to zero.