A phase I study evaluating the pharmacokinetics, safety and tolerability of an antibody-based tissue factor antagonist in subjects with acute lung injury or acute respiratory distress syndrome

Table 1 Baseline characteristics

Characteristics	Placebo (n = 3)	0.06 mg/kg ALT-836 (n = 5)	0.08 mg/kg ALT-836 (n = 5)	0.10 mg/kg ALT-836 (n = 5)
Age, yr	49.7 ± 24.3	40.4 ± 18.2	54.0 ± 16.9	54.6 ± 13.7
Male, n (%)	1 (33.3)	1 (20.0)	2 (40.0)	0 (0.0)
Baseline APACHE II Score	22.7 ± 14.2	20.2 ± 5.5	20.0 ± 3.1	19.2 ± 5.1
Baseline respiratory variables
PO₂/FIO₂	226 ± 51	205 ± 65	221 ± 64	200 ± 48
Respiratory rate, bpm	28.7 ± 4.2	20.3 ± 6.9	20.60 ± 3.3^a	19.8 ± 7.2
pH	7.34 ± 0.09	7.35 ± 0.07	7.44 ± 0.04	7.39 ± 0.06
PEEP, cm H₂O	10.0 ± 5.0	10.3 ± 5.6	10.4 ± 6.2	9.2 ± 4.1
Baseline coagulation & hematology variables
Prothrombin time, sec	17.0 ± 2.4	12.1 ± 1.5	14.8 ± 1.9	13.9 ± 0.3
aPTT, sec	32.9 ± 0.3	29.1 ± 2.5	31.1 ± 1.8	29.2 ± 1.7
Platelets, 10⁶/ml	238 ± 115	256 ± 105	357 ± 309	244 ± 43
Hemoglobin, g/dl	10.7 ± 0.3	9.5 ± 1.2	10.0 ± 1.4	10.0 ± 1.8

APACHE II, Acute Physiology and Chronic Health Evaluation; PEEP, Positive end-expiratory pressure; aPTT, activated partial thromboplastin time
Values are means ± SD unless otherwise noted
^a P < 0.05 compared to placebo group

ISSN: 1471-2466