Migraine
Conditions
Brief summary
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of ALD1910, a monoclonal antibody, administered by intravenous infusion and subcutaneous injection.
Detailed description
This is a first-in-humam, randomized, double-blind, placebo-controlled study in a healthy population. Up to 7 single ascending doses (cohorts 1 to 7) will be studied to determine the safety and tolerability of ALD1910. Approximately 96 healthy male and female participants are planned for the study, 64 for Part A and 32 for Part B.
Interventions
BIOLOGICALALD1910
Single Dose IV infusion
BIOLOGICALSumatriptan
Single dose subcutaneous injection
Sponsors
Alder Biopharmaceuticals, Inc.
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female 2. All female subjects must have a negative pregnancy test result and subjects to use of adequate contraception for the duration of the study. 3. Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, and a total body weight of 50 to 100 kg inclusive.
Exclusion criteria
1. Use of prescription meds, nutritional supplements, OTC medications. 2. New or unusually strenuous exercise for the duration of the trial. 3. Current or previous drug or alcohol abuse. 4. Current, or previous smoker within 12 weeks prior to screening. Causal or social smokers are allowed. 5. Previous treatment or clinical trial with a monoclonal antibody 6 months prior to screening. 6. Current participation in any clinical research study. 7. ECG QTcF greater than or equal to 450 msec. 8. Greater than 6.4% glycosylated hemoglobin (HgbA1c) at screening 9. Fasting blood glucose greater than or equal to 126 mg/dL (7 mmol/L) at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-emergent adverse events | From dosing to week 20 | Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, ECG parameters) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the serum concentration-time curve (AUC(0-T)) | From dosing to week 20 | — |
| Peak serum concentration (Cmax) | From dosing to week 20 | — |
| Clearance (Cl) | From dosing to week 20 | — |
| Immunogenicity | From dosing to week 20 | Number of anti-ALD1910 antibodies (ADA) and characterization of anti-ALD1910 ADA positive responses for neutralizing activity |
Countries
Australia
Outcome results
None listed