Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of ALD403

Exclusion Criteria18

• Women who are pregnant, planning to become pregnant, or breastfeeding
• Clinically significant laboratory findings showing evidence of organ dysfunction, any clinically significant deviation from the normal range, or clinically significant physical exam abnormalities at screening, as evaluated by the Investigator
• Any ongoing co-morbidity or dermatological condition (e.g., psoriasis, eczema, severe acne requiring treatment) that in the opinion of the Investigator will interfere with the evaluation and participation in the trial
• The presence of tattoos on the forearm, chest, or abdominal region that could interfere with the evaluation of safety and study endpoints in the trial
• 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
• Use of any concomitant medications within 14 days of dosing, unless authorized by the Sponsor and/or PI
• 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
• 12-lead ECG demonstrating QTcF > 450 msec at Screening. If QTcF exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTcF values should be used to determine the subject's eligibility
• 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 or positive urine drugs of abuse result at screening
• History of capsaicin allergy
• Less than or equal to 50% Increase in perfusion (skin blood flow) following topical capsaicin challenge relative to vehicle challenge at screening
• 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) or previous treatment with ALD403
• Planned or current participation in any other clinical trial during this clinical trial