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

April 16, 2012
April 25, 2013
April 2012
December 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01579383 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Safety Tolerability and Pharmacokinetics of ALD403
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Migraine Disorders
  • Biological: ALD403
    Single Dose IV infusion on Day 1
  • Biological: ALD403
    Single Dose subcutaneous injection on Day 1
  • Biological: Sumatriptan
    Single Dose subcutaneous injection on Day 1
  • Experimental: Part A, Cohorts A - H
    ALD403/Placebo
    Intervention: Biological: ALD403
  • Experimental: Part A, Cohort I
    ALD403/Placebo
    Intervention: Biological: ALD403
  • Experimental: Part B
    ALD403/Placebo/Sumatriptan
    Interventions:
    • Biological: ALD403
    • Biological: Sumatriptan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
April 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01579383
ALD403-CLIN-001
No
Alder Biopharmaceuticals, Inc.
Alder Biopharmaceuticals, Inc.
Not Provided
Principal Investigator: Peter Hodsman, MD Nucleus Network
Alder Biopharmaceuticals, Inc.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP