Subject disposition and demographics for parts A and B
| Parameter | Part A Total | Part B | ||
|---|---|---|---|---|
| Placebo | 2000 µg | Total | ||
| Number of subjects | ||||
| Number of subjects planned (N) | 32 | 3 | 9 | |
| Number of subjects randomized (N) | 37 | 3 | 9 | |
| Number of subjects completed as planned [n (%)] | 29 (78) | 3 (100) | 9 (100) | |
| Number of subjects withdrawn (any reason) [n (%)] | 8 (22) | 0 (0) | 0 (0) | |
| Number of subjects withdrawn for AE [n (%)] | 1 (3) | |||
| Other reasons for subject withdrawal [n (%)] | ||||
| Withdrew consent | 2 (5) | |||
| Investigator discretion | 5 (14) | |||
| Positive drug screen | 2 (5) | |||
| Withdrawn due to raised/elevated ALT | 2 (5) | |||
| Chest tightness overnight | 1 (3) | |||
| Demographics | (n = 37) | (n = 3) | (n = 9) | (n = 12) |
| Age in years [mean (S.D.)] | 34.4 (8.73) | 30.3 (3.21) | 35.4 (10.01) | 34.2 (8.95) |
| Sex [n (%)] | ||||
| Female | 0 | 0 | 0 | 0 |
| Male | 37 (100) | 3 (100) | 9 (100) | 12 (100) |
| BMI (kg/m2) [mean (S.D.)] | 25.92 (3.22) | 22.94 (2.81) | 26.05 (3.40) | 25.27 (3.43) |
| Height (cm) [mean (S.D.)] | 180.49 (7.07) | 182.33 (10.02) | 183.78 (6.70) | 183.42 (7.17) |
| Weight (kg) [mean (S.D.)] | 84.44 (11.73) | 76.27 (10.83) | 88.11 (13.51) | 85.15 (13.52) |
| Ethnicity [n (%)] | ||||
| Hispanic or Latino | 1 (3) | 0 | 1 (11) | 1 (8) |
| Not Hispanic or Latino | 36 (97) | 3 (100) | 8 (89) | 11 (92) |
| Race [n (%)] | ||||
| African American/African Heritage | 2 (5) | |||
| Asian: Central/South Asian Heritage | 1 (3) | |||
| White: White/Caucasian/European Heritage | 34 (92) | 3 (100) | 9 (100) | 12 (100) |
| Screening FEV1 (L) [Mean (S.D.)] | 4.35 (0.69) | 4.27 (0.14) | 4.63 (0.72)a | 4.53 (0.63)b |
| Predicted normal FEV1 [(%), mean (S.D.)] | 97 (8.22) | 91 (8.72) | 100 (11.15)a | 97 (10.97)b |