Table 5.

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

		ELX‐02 Dose
Parameter	Statistics	0.1 mg/kga (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
Ae12h, mg	Mean	6.39	14.62	56.97	155.16	319.94
	SD	1.04	1.26	11.29	18.43	53.52
fe12h, %	Mean	79.91	78.92	76.38	89.98	82.47
	SD	8.22	4.95	12.17	7.84	4.59
Rmax, mg	Mean	1.92	4.77	16.31	42.40	69.83
	SD	0.58	0.32	2.45	8.45	9.59
TRmax, h	Median	1.00	0.50	1.50	1.50	1.50
	Minimum	0.50	0.50	0.50	0.50	1.50
	Maximum	1.05	1.50	1.50	1.50	1.50
CLR24h, L/h	Mean	5.99	4.84	5.34	5.79	5.39
	SD	1.27	0.47	1.02	1.27	0.85
Day 29
Ae12h, mg	Mean	6.28	14.52	64.99	157.50	389.93
	SD	1.60	1.22	10.17	20.71	55.45
fe12h, %	Mean	76.74	78.44	89.08	89.04	94.47
	SD	10.67	2.83	14.07	4.98	7.41
Rmax, mg	Mean	2.04	5.08	18.84	41.25	90.43
	SD	0.61	0.76	5.09	7.94	12.89
TRmax, h	Median	0.50	0.50	1.50	1.50	1.50
	Minimum	0.50	0.50	0.50	0.50	1.50
	Maximum	1.50	1.50	1.50	1.50	2.05
CLR24h, L/h	Mean	5.32	4.81	6.14	5.63	7.25
	SD	1.39	0.52	0.98	1.55	0.57

Ae_12h, amount of unchanged drug excreted into the urine at 12 hours; CL_R24h, renal clearance at 24 hours; fe_12h, fraction of the drug excreted in the urine at 12 hours; PK, pharmacokinetic; R_max, maximum accumulation ratio; TR_max, median peak excretion.

^a n = 5 for CL_R24h in the 0.1 mg/kg group.