TABLE 2.
Demographic characteristics of the phase 1b MAD study population
| Characteristic | Data by treatment group |
||||
|---|---|---|---|---|---|
| LHF-535 (mg/kg) |
All LHF-535 | Placebo | |||
| 450 | 900 | 1,125a | |||
| No. of subjects | 6 | 6 | 6 | 18 | 6 |
| Age (yrs) | |||||
| Mean | 28.0 | 32.0 | 30.3 | 30.1 | 31.5 |
| SD | 3.69 | 3.69 | 7.45 | 5.21 | 12.39 |
| Median | 28.0 | 33.5 | 30.0 | 30.5 | 30.0 |
| Range | 22–33 | 25–35 | 23–39 | 22–39 | 19–50 |
| Gender (n [%]) | |||||
| Male | 2 (33.3) | 4 (66.7) | 3 (50.0) | 9 (50.0) | 5 (83.3) |
| Female | 4 (66.7) | 2 (33.3) | 3 (50.0) | 9 (50.0) | 1 (16.7) |
| Race (n [%]) | |||||
| American Indian or Alaska Native | 0 (0.0) | 0 (0.0) | 1 (16.7) | 1 (5.6) | 0 (0.0) |
| Asian | 0 (0.0) | 1 (16.7) | 1 (16.7) | 2 (11.1) | 0 (0.0) |
| White | 6 (100) | 5 (83.3) | 4 (66.7) | 15 (83.3) | 6 (100) |
| Body wt (kg) at screening | |||||
| Mean | 69.0 | 70.6 | 86.0 | 75.2 | 77.7 |
| SD | 11.38 | 9.50 | 10.00 | 12.49 | 17.54 |
| Median | 68.3 | 69.7 | 86.1 | 73.8 | 74.1 |
| Range | 56.4–88.3 | 57.3–85.5 | 74.1–99.6 | 56.4–99.6 | 53.3–105.2 |
| BMI (kg/m2) at screening | |||||
| Mean | 23.5 | 22.8 | 28.3 | 24.9 | 25.0 |
| SD | 2.78 | 1.99 | 3.60 | 3.69 | 3.81 |
| Median | 23.6 | 22.4 | 27.9 | 24.5 | 23.3 |
| Range | 20.2–27.3 | 20.3–25.7 | 24.5–34.2 | 20.2–34.2 | 22.0–29.8 |
a
Participants in the 1,125-mg group received a loading dose of 2,250 mg once on day 1, followed by a maintenance dose of 1,125 mg/day on days 2 through 14.