Participants
Healthy subjects ≥18 and ≤65 years-of-age were enrolled with body mass
index ≥18.5 and ≤32.0kg/m2 and body weight ≤120kg.
Participants had to be willing/able to provide consent and adhere to
trial requirements. All participants of childbearing potential were on
acceptable birth control. Main exclusion criteria were estimated:
creatinine clearance <90mL/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.