Migraine DisordersPhase 1NCT01579383
Safety Tolerability and Pharmacokinetics of ALD403
A Phase 1 study testing ALD403 and Sumatriptan in people with Migraine Disorders, run by Alder Biopharmaceuticals, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- ALD403 and Sumatriptan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2012to Apr 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 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.
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- 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
Who cannot join
- 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.
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- 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
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Centre for Clinical Studies, Nucleus Network
Melbourne, Victoria, 3004
About this study
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
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.
- Conditions
- Migraine Disorders
- Being tested
- ALD403, Sumatriptan
- Keywords
- Migraine Disorders, Phase 1, ALD403
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALD403Biological
Single Dose IV infusion on Day 1
ALD403Biological
Single Dose subcutaneous injection on Day 1
SumatriptanBiological
Single Dose subcutaneous injection on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Part A, Cohorts A - H | Experimental | ALD403/Placebo Receives: Biological: ALD403 |
| Part A, Cohort I | Experimental | ALD403/Placebo Receives: Biological: ALD403 |
| Part B | Experimental | ALD403/Placebo/Sumatriptan Receives: Biological: ALD403; Biological: Sumatriptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of ALD403: laboratory variables, ECG and adverse events
- Physical Examination
- Vital signs
- 12-lead ECG (electrocardiogram)
- Clinical laboratory tests (hematology, chemistry)
- Number of participants with Adverse Events
Measured: 12 weeks
Secondary outcomes (2)
Evaluation of Pharmacokinetics of ALD403
- 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
Measured: 12 weeks
Evaluation of pharmacodynamics of ALD403
- Blood perfusion rates
- Plasma levels of unbound ALD403
- Immunogenicity
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alder Biopharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Hodsman, MD, Principal investigator, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579383
- Sponsor's protocol ID
- ALD403-CLIN-001
- Status last verified
- Apr 2013
- First submitted
- 16 Apr 2012
- Last updated
- 26 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01579383
- Acronym / sponsor ID
- ALD403-CLIN-001
- Conditions
- Migraine Disorders
- Keywords
- Migraine Disorders, Phase 1, ALD403
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Alder Biopharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 18 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A, Cohorts A - H | Experimental | Biological: ALD403ALD403/Placebo |
| Part A, Cohort I | Experimental | Biological: ALD403ALD403/Placebo |
| Part B | Experimental | Biological: ALD403, Biological: SumatriptanALD403/Placebo/Sumatriptan |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Healthy females between the ages of 18 and 65 (inclusive).
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALD403Single Dose IV infusion on Day 1 | Biological | Part A, Cohorts A - H, Part B |
| ALD403Single Dose subcutaneous injection on Day 1 | Biological | Part A, Cohort I |
| SumatriptanSingle Dose subcutaneous injection on Day 1 | Biological | Part B |
Primary outcome
Safety and tolerability of ALD403: laboratory variables, ECG and adverse events
Time frame: 12 weeks
* Physical Examination * Vital signs * 12-lead ECG (electrocardiogram) * Clinical laboratory tests (hematology, chemistry) * Number of participants with Adverse Events
2 secondary outcomes
Evaluation of Pharmacokinetics of ALD403
Time frame: 12 weeks
Evaluation of pharmacodynamics of ALD403
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Hodsman, MD principal investigator
Nucleus Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALD403 and Sumatriptan in people with Migraine Disorders, run by Alder Biopharmaceuticals, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of ALD403: laboratory variables, ECG and adverse events (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2013; AzTrials last refreshed its copy on 7 Nov 2026.