Table 2.
Baseline demographics in the phase 1 PK study (n=18)
| Phase 1 | ||
|---|---|---|
|
| ||
| Parameter (mean) | Mean (SD) | Range |
| n | 18 | |
| Age (year) | 36 (5.8) | 27–44 |
| Height (cm) | 182 (6.6) | 171–198 |
| Weight (kg) | 84.9 (9.72) | 65–103 |
| BMI (kg/m2) | 25.4 (2.49) | 22.2–29.8 |
| Pre-study, Cmax testosterone (ng/dL) | 631.4 (149.7) | 393–848 |
| Pre-study, Cavg testosterone* (ng/dL) | 456 (92) | 305–611 |
| TNSS in ACC at screening | ||
| 1 hour | 6.67 (1.81) | 4–12 |
| 2 hours | 7.56 (2.28) | 4–12 |
*
Average of two morning serum testosterone measures.
ACC: allergy challenge chamber; BMI: body mass index; Cavg: average of the observed concentration; Cmax: maximum observed concentration; PK: pharmacokinetics; SD: standard deviation; TNSS: Total Nasal Symptom Score.