Table 1.
Baseline demographic and disease characteristics of subjects
| Category | Part 1 (healthy subjects) | Part 2 (subjects with moderate-to-severe AD) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AK120 15 mg (N = 6) |
AK120 50 mg (N = 6) |
AK120 150 mg (N = 6) |
AK120 300 mg (N = 6) |
AK120 600 mg (N = 6) |
AK120 Total (N = 30) |
Placebo (N = 10) |
AK120 75 mg QW (N = 8) |
AK120 150 mg QW (N = 8) |
AK120 300 mg QW (N = 8) |
AK120 300 mg Q2W (N = 8) |
AK120 Total (N = 32) |
Placebo (N = 9) |
|
| Age (years), mean (SD) | 30.8 (13.5) | 24.8 (8.7) | 26.2 (6.2) | 32.2 (11.2) | 25.5 (3.3) | 27.9 (9.2) | 33.3 (7.8) | 28.6 (9.26) | 39.4 (13.94) | 33.8 (15.04) | 33.8 (11.88) | 33.9 (12.69) | 24.3 (6.48) |
| Male sex, n (%) | 1 (16.7) | 2 (33.3) | 1 (16.7) | 1 (16.7) | 1 (16.7) | 6 (20.0) | 2 (20.0) | 5 (62.5) | 5 (62.5) | 2 (25.0) | 5 (62.5) | 17 (53.1) | 4 (44.4) |
| Race, n (%) | |||||||||||||
| White | 5 (83.3) | 6 (100.0) | 4 (66.7) | 5 (83.3) | 5 (83.3) | 25 (83.3) | 9 (90.0) | 5 (62.5) | 7 (87.5) | 5 (62.5) | 5 (62.5) | 22 (68.8) | 3 (33.3) |
| Asian | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 1 (3.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (25.0) |
2 (6.3) |
4 (44.4) |
| Native Hawaiian or other Pacific Islander | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (12.5) | 1 (12.5) | 0 (0.0) |
2 (6.3) |
0 (0.0) |
| Other | 1 (16.7) | 0 (0.0) | 2 (33.3) | 0 (0.0) | 1 (16.7) | 4 (13.3) | 1 (10.0) | 3 (37.5) | 0 (0.0) | 2 (25.0) | 1 (12.5) |
6 (18.8) |
2 (22.2) |
| BMI (kg/m2), mean (SD) | 21.9 (1.8) | 23.6 (1.8) | 24.0 (4.2) | 23.1 (2.5) | 25.7 (2.5) | 23.7 (2.8) | 25.4 (3.6) | 24.8 (5.9) | 29.7 (5.6) | 29.5 (5.7) | 27.7 (4.1) |
27.9 (5.5) |
22.2 (3.5) |
| EASI score, mean (SD) | NA | 38.7 (14.6) | 21.9 (9.4) | 31.1 (8.4) | 40.4 (17.7) |
33.0 (14.5) |
32.7 (11.9) | ||||||
| IGA score, n (%) | |||||||||||||
| 3 | NA | 5 (62.5) | 7 (87.5) | 5 (62.5) | 4 (50.0) |
21 (65.6) |
5 (55.6) | ||||||
| 4 | NA | 3 (37.5) | 1 (12.5) | 2 (25.0) | 3 (37.5) |
9 (28.1) |
4 (44.4) | ||||||
| 5 | NA | 0 (0.0) | 0 (0.0) | 1 (12.5) | 1 (12.5) |
2 (6.3) |
0 (0.0) | ||||||
| BSA affected, mean (SD) | NA | 78.5 (19.8) | 51.1 (24.8) | 56.9 (18.1) | 75.0 (16.0) |
65.4 (22.3) |
55.2 (24.9) | ||||||
| Average P-NRS score, mean (SD) | NA | 5.8 (1.8) | 6.3 (1.9) | 6.4 (1.3) | 7.3 (1.7) |
6.5 (1.7) |
5.8 (1.6) | ||||||
AD Atopic dermatitis, BMI body mass index, BSA body surface area, EASI Eczema Area and Severity Index, IGA Investigator Global Assessment, NA not applicable, P-NRS Pruritus-Numeric Rating Scale, QW once weekly, Q2W every 2 weeks, SD standard deviation