Participants
Healthy subjects ≥18 and ≤65 years of age were enrolled with body mass
index ≥18.5 and ≤32.0 kg/m2 and body weight ≤120 kg.
Participants had to be willing and able to provide consent and adhere to
trial requirements. All participants of childbearing potential were on
acceptable birth control. The main exclusion criteria were estimated
creatinine clearance <90 mL/min, history of clinical
hypersensitivity or allergy to any pharmaceutical agent, chronically
administered antihistamines or corticosteroids within the last 28 days,
and significant mental illness. Tattoos, scarring, or other abdominal
skin characteristics which could confound assessment of ISRs were also
considered exclusion criteria.