Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01579383




Registration number
NCT01579383
Ethics application status
Date submitted
16/04/2012
Date registered
18/04/2012
Date last updated
26/04/2013

Titles & IDs
Public title
Safety Tolerability and Pharmacokinetics of ALD403
Scientific 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
Secondary ID [1] 0 0
ALD403-CLIN-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine Disorders 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - ALD403
Other interventions - ALD403
Other interventions - Sumatriptan

Experimental: Part A, Cohorts A - H - ALD403/Placebo

Experimental: Part A, Cohort I - ALD403/Placebo

Experimental: Part B - ALD403/Placebo/Sumatriptan


Other interventions: ALD403
Single Dose IV infusion on Day 1

Other interventions: ALD403
Single Dose subcutaneous injection on Day 1

Other interventions: Sumatriptan
Single Dose subcutaneous injection on Day 1
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of ALD403: laboratory variables, ECG and adverse events
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Evaluation of Pharmacokinetics of ALD403
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Evaluation of pharmacodynamics of ALD403
Timepoint [2] 0 0
12 weeks

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2013
Sample size
Target
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Centre for Clinical Studies, Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alder Biopharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01579383
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Hodsman, MD
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01579383