Migraine Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase 1 Study to Determine the Safety, Tolerability, and Pharmacokinetics of ALD1910, a Humanized Anti-Pituitary Adenylate Cyclase Activating Peptide (PACAP) Monoclonal Antibody
Verified date | September 2020 |
Source | H. Lundbeck A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 96 |
Est. completion date | August 19, 2020 |
Est. primary completion date | August 19, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Australia | Nucleus Network Pty Ltd | Melbourne |
Lead Sponsor | Collaborator |
---|---|
H. Lundbeck A/S | Alder Biopharmaceuticals, Inc. |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with treatment-emergent adverse events | Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, ECG parameters) | From dosing to week 20 | |
Secondary | Area under the serum concentration-time curve (AUC(0-T)) | From dosing to week 20 | ||
Secondary | Peak serum concentration (Cmax) | From dosing to week 20 | ||
Secondary | Clearance (Cl) | From dosing to week 20 | ||
Secondary | Immunogenicity | Number of anti-ALD1910 antibodies (ADA) and characterization of anti-ALD1910 ADA positive responses for neutralizing activity | From dosing to week 20 |
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