Table 1.
Baseline demographic characteristics of participants in phase 1 and phase 2 trials
|
Phase 1 trial (n=50) |
Phase 2 trial (n=900) |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Placebo, three-dose (n=10) | 25 μg, three-dose (n=20) | 50 μg, three-dose (n=20) | Placebo, two-dose (n=150) | 25 μg, two-dose (n=150) | 50 μg, two-dose (n=150) | Placebo, three-dose (n=150) | 25 μg, three-dose (n=150) | 50 μg, three-dose (n=150) | ||
| Age (years) | ||||||||||
| Mean (SD) | 32·5 (11·3) | 31·7 (9·7) | 33·6 (8·5) | 44·1 (9·3) | 43·04 (9·6) | 44·4 (8·4) | 43·4 (8·9) | 42·7 (9·4) | 43·2 (9·4) | |
| Median (IQR) | 29·4 (21·0–57·9) | 26·7 (22·9–54·7) | 34·1 (20·9–49·4) | 46·1 (20·7–59·4) | 43·7 (18·8–58·4) | 45·3 (19·9–59·1) | 44·4 (20·7–58·0) | 43·7 (20·0–59·7) | 43·7 (19·3–59·6) | |
| Ethnicity | ||||||||||
| Han Chinese | 9 (90%) | 20 (100%) | 18 (90%) | 149 (99%) | 150 (100%) | 150 (100%) | 149 (99%) | 150 (100%) | 148 (99%) | |
| Other | 1 (10%) | 0 | 2 (10%) | 1 (1%) | 0 | 0 | 1 (1%) | 0 | 2 (1%) | |
| Sex | ||||||||||
| Male | 5 (50%) | 14 (70%) | 11 (55%) | 68 (45%) | 65 (43%) | 57 (38%) | 74 (49%) | 71 (47%) | 63 (42%) | |
| Female | 5 (50%) | 6 (30%) | 9 (45%) | 82 (55%) | 85 (57%) | 93 (62%) | 76 (51%) | 79 (53%) | 87 (58%) | |
| Mean BMI kg/m2 (SD) | 22·5 (1·5) | 24·0 (2·8) | 22·6 (2·8) | NR | NR | NR | NR | NR | NR | |
Data are mean (SD), median (IQR), or n (%). BMI=body-mass index. NR=not recorded.