Migraine Disorders
Conditions
Keywords
Migraine Disorders, Phase 1, ALD403
Brief summary
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of ALD403, a monoclonal antibody, administered by intravenous infusion and subcutaneous injection.
Interventions
BIOLOGICALALD403
Single Dose IV infusion on Day 1
BIOLOGICALSumatriptan
Single Dose subcutaneous injection on Day 1
Sponsors
Alder Biopharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Part A: * Healthy males and females between the ages of 18 and 65 (inclusive). * 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 100kg inclusive. * No clinically significant disease or abnormal laboratory values as determined by medical history, physical examination, electrocardiogram, and laboratory evaluations
Exclusion criteria
Part A: * History of febrile illness within 5 days prior to the first dose * Any clinically significant laboratory findings * Any clinically significant physical exam abnormalities * Hospitalization for any reason within 30 days of the screening visit. * History of or positive human immunodeficiency virus (HIV) screen result * History of positive Hepatitis B surface antigen (HBsAg), and/or positive Hepatitis C antibody (HCV) at screening. * History of malignancy within five years prior to screening. * History of leukemia, myeloproliferative disorder or lymphoproliferative disorder * History of rubber, latex allergy or allergy to medical adhesives * Positive urine, drug or alcohol screen result * Current smokers * Previous treatment or clinical trial with a monoclonal antibody. * Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives Inclusion Criteria Part B: * Healthy females between the ages of 18 and 65 (inclusive). * Male and female migraine patients with clinically diagnosed migraine not attributed to another cause with or without aura based on International Headache Society criteria. * Migraine patients must have a history of migraine with or without aura for more than 1 year with 1-8 moderate or severe migraine attacks per month in the 2 months prior to starting in the study. * Normal renal function as defined by 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 100kg inclusive. * No clinically significant disease or abnormal laboratory values as determined by medical history, physical examination, electrocardiogram, and laboratory evaluations conducted at the screening visit or at the time of admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of ALD403: laboratory variables, ECG and adverse events | 12 weeks | * Physical Examination * Vital signs * 12-lead ECG (electrocardiogram) * Clinical laboratory tests (hematology, chemistry) * Number of participants with Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Pharmacokinetics of ALD403 | 12 weeks | * Cmax - maximum plasma concentration * Tmax - Time to achieve maximum plasma concentration * AUC - Area under the plasma concentration-time curve * T1/2 - Elimination half-life * Vz - Volume of distribution * CL - Clearance * Bioavailability |
| Evaluation of pharmacodynamics of ALD403 | 12 weeks | * Blood perfusion rates * Plasma levels of unbound ALD403 * Immunogenicity |
Countries
Australia
Outcome results
None listed