Safety Tolerability and Pharmacokinetics of ALD403

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01579383
First received: April 16, 2012
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Migraine Disorders
Biological: ALD403
Biological: Sumatriptan
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Single Dose, Placebo-Controlled, Ascending Dose Study to Determine the Safety, Tolerability and Pharmacokinetics of ALD403, a Humanized Anti-Calcitonin Gene-Related Peptide Monoclonal Antibody Administered by Intravenous Infusion and Subcutaneous Injection

Resource links provided by NLM:


Further study details as provided by Alder Biopharmaceuticals, Inc.:

Primary Outcome Measures:
  • Safety and tolerability of ALD403: laboratory variables, ECG and adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    • Physical Examination
    • Vital signs
    • 12-lead ECG (electrocardiogram)
    • Clinical laboratory tests (hematology, chemistry)
    • Number of participants with Adverse Events


Secondary Outcome Measures:
  • Evaluation of Pharmacokinetics of ALD403 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    • Blood perfusion rates
    • Plasma levels of unbound ALD403
    • Immunogenicity


Enrollment: 104
Study Start Date: April 2012
Study Completion Date: April 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A, Cohorts A - H
ALD403/Placebo
Biological: ALD403
Single Dose IV infusion on Day 1
Experimental: Part A, Cohort I
ALD403/Placebo
Biological: ALD403
Single Dose subcutaneous injection on Day 1
Experimental: Part B
ALD403/Placebo/Sumatriptan
Biological: ALD403
Single Dose IV infusion on Day 1
Biological: Sumatriptan
Single Dose subcutaneous injection on Day 1

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

Exclusion Criteria Part B:

  • For migraine patients: patient is not able to refrain from use of their usual triptan therapy (if applicable) from 48 hours (Day -2) prior to dosing on Day 1 until the morning of discharge (Day 3).
  • Migraine patients who experience migraine with prolonged aura, familiar hemiplegic migraine, migrainous infarction or basilar migraine
  • For migraine patients: patient has more than 8 headache-days per month or has taken medication for acute headache on more than 8 days a month in the past 3 months
  • For migraine patients: patient was greater than 50 years old at the age of migraine onset
  • History of febrile illness within 5 days prior to the first dose
  • Any clinically significant laboratory findings
  • Any clinically significant physical exam abnormalities
  • Previous treatment or clinical trial with a monoclonal antibody.
  • 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
  • History of malignancy within five years prior to screening.
  • History of leukemia, myeloproliferative disorder or lymphoproliferative disorder
  • Positive urine drug or alcohol screen result
  • Current smokers.
  • Known contraindication to sumatriptan
  • Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579383

Locations
Australia, Victoria
Centre for Clinical Studies, Nucleus Network
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Alder Biopharmaceuticals, Inc.
Investigators
Principal Investigator: Peter Hodsman, MD Nucleus Network
  More Information

No publications provided

Responsible Party: Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01579383     History of Changes
Other Study ID Numbers: ALD403-CLIN-001
Study First Received: April 16, 2012
Last Updated: April 25, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Alder Biopharmaceuticals, Inc.:
Migraine Disorders
Phase 1
ALD403

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Calcitonin Gene-Related Peptide
Sumatriptan
Calcitonin
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Bone Density Conservation Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014