Table 1.
Demographic Characteristics (Safety Population).
| Characteristics | Low Dose N = 51 |
Medium Dose N = 51 |
High Dose N = 51 |
Overall N = 153 |
|---|---|---|---|---|
| Age at time of informed consent (years) | ||||
| N | 51 | 51 | 51 | 153 |
| Mean (SD) | 33.7 (8.89) | 35.5 (9.53) | 31.3 (8.52) | 33.5 (9.10) |
| Median | 31.0 | 33.0 | 29.0 | 32.0 |
| Min, max | 21, 53 | 21, 55 | 18, 54 | 18, 55 |
| Sex, n (%) | ||||
| Male | 27 (52.9) | 34 (66.7) | 22 (43.1) | 83 (54.2) |
| Female | 24 (47.1) | 17 (33.3) | 29 (56.9) | 70 (45.8) |
| Diverse | 0 | 0 | 0 | 0 |
| Childbearing potential | ||||
| N | 51 | 51 | 51 | 153 |
| Yes | 23 (45.1) | 16 (31.4) | 28 (54.9) | 67 (43.8) |
| No | 1 (2.0) | 1 (2.0) | 1 (2.0) | 3 (2.0) |
| Reason for no childbearing potential | ||||
| Surgically sterile | 1 (2.0) | 0 | 0 | 1 (0.7) |
| Postmenopausal | 0 | 1 (2.0) | 1 (2.0) | 2 (1.3) |
| Ethnicity, n (%) | ||||
| White | 46 (90.2) | 51 (100.0) | 46 (90.2) | 143 (93.5) |
| Black | 0 | 0 | 0 | 0 |
| Asian | 1 (2.0) | 0 | 0 | 1 (0.7) |
| Mixed | 0 | 0 | 4 (7.8) | 4 (2.6) |
| LatinA | 1 (2.0) | 0 | 0 | 1 (0.7) |
| Latin AmericanA | 2 (3.9) | 0 | 0 | 2 (1.3) |
| LatinoA | 1 (2.0) | 0 | 0 | 1 (0.7) |
| White EuropeanB | 0 | 0 | 1 (2.0) | 1 (0.7) |
| Body Mass Index (BMI) at screening (kg/m2) | ||||
| N | 51 | 51 | 51 | 153 |
| Mean (SD) | 24.87 (2.962) | 25.06 (2.238) | 24.5 (3.085) | 24.81 (2.778) |
| Median | 24.7 | 24.9 | 24.5 | 24.8 |
| Min, Max | 19.6, 29.9 | 20.2, 29.2 | 18.1, 29.8 | 18.1, 29.9 |
| COVID-19 test result at screening | ||||
| Positive | 0 | 0 | 0 | 0 |
| Negative | 51 (100.0) | 51 (100.0) | 51 (100.0) | 153 (100.0) |
| Hepatitis-BsAg test result at screening | ||||
| Positive | 0 | 0 | 0 | 0 |
| Negative | 51 (100.0) | 51 (100.0) | 51 (100.0) | 153 (100.0) |
| HCV test result at screening | ||||
| Positive | 0 | 0 | 0 | 0 |
| Negative | 51 (100.0) | 51 (100.0) | 51 (100.0) | 153 (100.0) |
| HIV test result at screening | ||||
| Positive | 0 | 0 | 0 | 0 |
| Negative | 51 (100.0) | 51 (100.0) | 51 (100.0) | 153 (100.0) |
Max=maximum; Min=minimum; SD=standard deviation
A: Latin/Latino American / Latino: confirmed all 4 participants as Latin American with Mexico as country of birth.
B: White European.