Table 1. Demographic Characteristics.
| Variable | Single ascending dose group | Multiple ascending dose group | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Muvalaplin | Placebo (n = 14) | Muvalaplin | Placebo (n = 11) | |||||||||||
| 1 mg (n = 6) | 10 mg (n = 6) | 30 mg (n = 6) | 100 mg (n = 6) | 200 mg (n = 5) | 400 mg (n = 6) | 800 mg (n = 6) | 30 mg (n = 8) | 100 mg (n = 8) | 300 mg (n = 9) | 500 mg (n = 8) | 800 mg (n = 15) | |||
| Characteristics | ||||||||||||||
| Age, median (IQR), y | 26.5 (25-35) | 35 (30-48) | 31.5 (29-44) | 27.5 (21-37) | 23 (23-24) | 21.5 (20-27) | 27 (24-34) | 23.5 (20-25) | 27.5 (25.5-32) | 28.5 (23-35) | 20 (20-26) | 22.5 (20.5-37.5) | 54 (23-64) | 27 (21-34) |
| Sex, No. (%) | ||||||||||||||
| Female | 2 (33) | 3 (50) | 2 (33) | 5 (83) | 4 (80) | 4 (67) | 6 (100) | 9 (64) | 4 (50) | 5 (63) | 8 (89) | 6 (75) | 4 (27) | 7 (64) |
| Male | 4 (67) | 3 (50) | 4 (67) | 1 (17) | 1 (20) | 2 (33) | 5 (36) | 4 (50) | 3 (38) | 1 (11) | 2 (25) | 11 (73) | 4 (36) | |
| BMI, median (IQR) | 22.3 (20.0-29.1) | 24.3 (22.6-28.2) | 25.6 (25.0-27.8) | 23.3 (21.5-23.9) | 23.3 (21.0-23.7) | 23.0 (21.3-23.2) | 24.2 (22.0-28.7) | 22.7 (21.3-24.4) | 25.9 (22.4-28.0) | 23.6 (21.6-28.1) | 24.5 (23.5-27.2) | 26.7 (25.1-27.2) | 24.7 (23.3-27.5) | 22.9 (20.0-26.7) |
| Race and ethnicity, No. (%) a | ||||||||||||||
| Ethnicity | ||||||||||||||
| Not Hispanic or Latino | 6 (100) | 6 (100) | 5 (83) | 6 (100) | 4 (80) | 6 (100) | 5 (83) | 14 (100) | 7 (88) | 7 (88) | 7 (78) | 7 (88) | 15 (100) | 11 (100) |
| Hispanic or Latino | 1 (17) | 1 (20) | 1 (17) | 1 (13) | 1 (13) | 2 (22) | 1 (13) | |||||||
| Race | ||||||||||||||
| American Indian or Alaska Native | 1 (20) | 1 (17) | 1 (13) | 1 (11) | 1 (13) | |||||||||
| Black | 1 (13) | 1 (13) | 2 (22) | 1 (7) | 1 (9) | |||||||||
| White | 6 (100) | 5 (83) | 6 (100) | 6 (100) | 4 (80) | 6 (100) | 4 (67) | 13 (93) | 6 (75) | 6 (75) | 5 (56) | 7 (88) | 13 (87) | 10 (91) |
| Multiracial | 1 (7) | 1 (17) | 1 (7) | 1 (13) | 1 (11) | 1 (7) | ||||||||
| Laboratory results, median (IQR), mg/dL b | ||||||||||||||
| Lp(a) | 15.9 (9.9-47.5) | 9.9 (9.9-9.9) | 36.5 (11.0-78.0) | 18.2 (15.1-24.5) | 9.9 (9.9-9.9) | 9.9 (9.9-47.5) | 10.5 (9.9-41.2) | 10.2 (9.9-19.6) | 56.7 (47.8-91.3) | 42.0 (36.6-48.8) | 64.4 (36.1-80.0) | 75.9 (53.0-81.1) | 52.1 (36.7-95.0) | 59.8 (38.4-70.5) |
| Total cholesterol | 164.4 (154.7-181.8) | 166.3 (143.1-170.2) | 177.9 (166.3-185.6) | 177.9 (139.2-185.6) | 139.2 (112.1-143.1) | 156.6 (135.4-181.8) | 166.3 (162.4-181.8) | 166.3 (143.1-212.7) | 162.4 (158.6-191.4) | 176.0 (160.5-203.0) | 170.2 (154.7-174.0) | 172.1 (154.7-197.2) | 189.5 (154.7-205.0) | 174.0 (166.3-189.5) |
| LDL cholesterol | 110.2 (104.4-116.0) | 98.6 (96.7-119.9) | 127.6 (108.3-135.4) | 104.4 (100.5-123.7) | 77.3 (54.1-81.2) | 87.0 (73.5-104.4) | 90.9 (85.1-108.3) | 114.1 (92.8-147.0) | 102.5 (96.7-125.7) | 119.9 (92.8-135.4) | 108.3 (92.8-112.1) | 119.9 (106.3-141.2) | 119.9 (92.8-131.5) | 119.9 (112.1-131.5) |
| HDL cholesterol | 56.1 (38.7-65.7) | 48.3 (42.5-61.9) | 54.1 (42.5-58.0) | 52.2 (50.3-58.0) | 50.3 (46.4-54.1) | 50.3 (50.3-73.5) | 58.0 (38.7-73.5) | 50.3 (50.3-58.0) | 52.2 (42.5-54.1) | 54.1 (46.4-61.9) | 58.0 (54.1-58.0) | 46.4 (40.6-52.2) | 54.1 (42.5-61.9) | 50.3 (46.4-58.0) |
| Triglycerides (IQR) | 95.7 (71.7-156.8) | 66.0 (56.7-117.8) | 105.9 (65.5-108.9) | 110.7 (71.7-132.0) | 62.9 (60.2-85.9) | 64.7 (53.1-124.9) | 77.5 (47.8-81.5) | 81.0 (71.7-96.5) | 62.0 (55.4-122.7) | 86.4 (66.4-115.1) | 60.2 (49.6-68.2) | 82.4 (74.9-94.8) | 83.3 (62.0-94.8) | 92.1 (70.0-130.2) |
| apo B100 | 70.3 (64.9-71.1) | 60.7 (60.3-73.0) | 81.3 (73.8-86.6) | 68.2 (66.6-80.8) | 51.8 (38.0-61.0) | 63.6 (51.7-70.0) | 62.9 (59.6-66.9) | 71.0 (59.7-92.9) | 70.4 (60.3-80.2) | 75.3 (63.4-86.6) | 68.6 (60.9-75.6) | 66.9 (63.4-80.1) | 71.8 (63.7-81.2) | 75.0 (69.7-81.1) |
Abbreviations: Apo B100, apolipoprotein B100; BMI, body mass index, calculated as weight in kilograms divided by height in meters squared; HDL, high-density lipoprotein; LDL, low-density lipoprotein; Lp(a), lipoprotein(a).
SI conversion factors: To convert HDL, LDL, and total cholesterol from mg/dL to mmol/L, multiply by 0.0259; triglyceride from mg/dL to mmol/L, multiply by 0.0113.
a
Race was determined by self-selection from closed categories.
b
Normal ranges for select analyses were Lp(a), 0 to 30 mg/dL; total cholesterol, 0 to 247 mg/dL; LDL cholesterol, 0 to 151 mg/dL; HDL cholesterol, 38.6 mg/dL; triglycerides, 0 to 238.1 mg/dL; apo B100 (male) 46 to 174 mg/dL and (female) 46 to 142 mg/dL.