Safety Tolerability and Pharmacokinetics of ALD403
This study is ongoing, but not recruiting participants.
Sponsor:
Alder Biopharmaceuticals, Inc.
Information provided by (Responsible Party):
Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01579383
First received: April 16, 2012
Last updated: September 24, 2012
Last verified: September 2012
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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:
Genetics Home Reference related topics:
Help Me Understand Genetics
MedlinePlus related topics:
Migraine
U.S. FDA Resources
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
Estimated Enrollment: | 96 |
Study Start Date: | April 2012 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | September 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
|
![](https://webarchive.library.unt.edu/web/20121018215810im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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
![](https://webarchive.library.unt.edu/web/20121018215810im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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 |
![](https://webarchive.library.unt.edu/web/20121018215810im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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: | September 24, 2012 |
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 October 17, 2012