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. 2024 Mar 29;68(5):e01455-23. doi: 10.1128/aac.01455-23

TABLE 1.

Demographics and baseline characteristics (safety population)a,b

Study 1 (IV infusion/oral switch) Study 2 (multiple doses of IV infusion)
PBO
(N = 3)
FMGX
1,000 mg and 600 mg IV; 800 mg oral
(N = 9)
PBO FMGX
PBO 1
(N = 8)
PBO 2
(N = 2)
PBO 3
(N = 2)
Cohort A
1,500/900 mg
(N = 9)
Cohort B
900/900 mg
(N = 6)
Cohort C
1,000/900 mg
(N = 6)
Cohort D
1,000/750 mg
(N = 6)
Cohort E
1,000/850 mg
(N = 6)
Cohort F
1,000/900 mg
(N = 6)
Sex (male, %) 67 100 25 0 0 22.2 0 16.7 33.3 50.0 16.7
Race (White/Black/Asian/Other, %) 67/0/33/0 78/11/0/11 87.5/0/12.5/0 100/0/0/0 100/0/0/0 66.7/0/0/33.3 100/0/0/0 83.3/0/0/16.7 100/0/0/0 83.3/0/16.7/0 83.3/16.7/0/0
Age, mean (SD) (years) 52 (11) 42 (18) 25 (4) 28 (3) 38 (15) 29 (13) 30 (11) 26 (6) 23 (2) 29 (3) 34 (11)
Weight, mean (SD) (kg) 74.8 (27.5) 79.4 (9.3) 64.7 (9.9) 65.8 (0.3) 67.1 (4.0) 68.7 (8.2) 74.8 (6.2) 67.7 (10.5) 70.6 (7.9) 71.6 (5.1) 73.2 (10.4)
Height, mean (SD) (cm) 170 (21) 179 (8) 167 (9) 174 (1) 174 (3) 169 (8) 174 (6) 173 (5) 174 (8) 172 (5) 172 (8)
BMI, mean (SD) (kg/m2) 25.4 (4.1) 24.9 (3.9) 23.1 (1.7) 21.9 (0.3) 22.2 (2.1) 24.0 (2.5) 24.7 (1.6) 22.5 (2.5) 23.3 (1.5) 24.2 (1.4) 24.7 (1.8)
a

Cohorts: PBO 1, PBO BID on day 1 and QD on days 2 to 7 IV infusion; PBO 2, PBO BID on days 1 and 2 and QD on days 3 to 7 IV infusion; PBO 3, PBO BID on day 1 and QD on days 2 to 7 IV infusion with ondansetron; A, 1,500 mg BID on day 1 and 900 mg QD on days 2 to 7 FMGX IV infusion; B, 900 mg BID on days 1 and 2 and 900 mg QD on days 3 to 7 FMGX IV infusion; C, 1,000 mg BID on day 1 and 900 mg QD on days 2 to 7 FMGX IV infusion with ondansetron; D, 1,000 mg BID on day 1 and 750 mg QD on days 2 to 7 FMGX IV infusion; E, 1,000 mg BID on day 1 and 850 mg QD on days 2 to 7 FMGX IV infusion; F, 1,000 mg BID on day 1 and 900 mg QD on days 2 to 7 FMGX IV infusion.

b

BID, twice daily; BMI, body mass index; FMGX, fosmanogepix; IV, intravenous; PBO, placebo; QD, once daily; SD, standard deviation.