Safety, Pharmacokinetics and Pharmacodynamics of ALD403

Phase 1

Completed

• Conditions: Migraine; Neurological - Other neurological disorders

• Registration Number: ACTRN12614000681651
• Lead Sponsor: Alder Biopharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-27
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception
Willing, committed, and able to comply with scheduled clinic visits and complete all trial-related procedures
Normal renal function as calculated by the Cockcroft-Gault equation at screening
Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, and a total body weight of 50 to 100 kg inclusive
No history or presence of any other medical illness Ex-smoker (>6 months from quitting) or non-smoker
Agree not to post any personal medical data related to the trial or information related to the trial on any website or social media site (e.g., Facebook, Twitter) until the trial has been completed

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified