Safety, Pharmacokinetics and Pharmacodynamics of ALD403

Exclusion Criteria12

• History of febrile illness within 5 days prior to dosing
• Clinically significant laboratory findings
• Any ongoing co-morbidity or dermatological condition The presence of tattoos on the forearm, chest, or abdominal region Any medical condition that could put the patient at increased risk with exposure to an anti-CGRP antibody such as pre-existing cardiovascular (hypertension, ischemic heart disease), cerebrovascular disease, diabetes, or Raynaud’s disease
• Onset of a new exercise routine or major change to a previous exercise routine within 2 weeks prior to screening visit. Subjects must be willing to refrain from unusually strenuous exercise for the duration of the trial
• Hospitalization for any reason within 30 days of the screening visit
• History of or positive human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), and/or Hepatitis C antibody (HCV) at screening
• History of malignancy other than adequately treated carcinoma in-situ of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin within five years prior to screening
• History of past or current habitual drug abuse, including alcohol abuse History of rubber/latex allergy, or allergy to medical adhesives
• History of capsaicin allergy
• Known sensitivity to any of the components of the Investigational Product formulation
• Receipt of any experimental, unregistered therapy (within or outside a clinical trial) within 30 days or 5 plasma half-lives (whichever is longer) before dosing
• Receipt of monoclonal antibody treatment within 6 months of screening (within or outside a clinical trial)