None listed
Conditions
Brief summary
Purpose: To determine the safety of multiple subcutaneous (SC) injections ALD403 compared to placebo in healthy female and male subjects. To determine the pharmacokinetics, pharmacodynamics, and immunogenicity of ALD403 compared to placebo in healthy female and male subjects.
Interventions
Group A: ALD403 C1 process-derived 100 mg administered subcutaneously (SC) in the anterior abdominal wall on Days 1, 29, 57
Group B: ALD403 C2 process-derived 100 mg administered subcutaneously (SC) in the anterior abdominal wall on Days 1, 29, 57
Doses will be administered by study personnel at site visits.
Sponsors
Alder Biopharmaceuticals
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
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)
Outcome results
None listed