Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Migraine

Intervention / Treatment
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* Biological: ALD1910
* Biological: Sumatriptan
* Biological: ALD1910


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female All female subjects must have a negative pregnancy test result and subjects to use of adequate contraception for the duration of the study. 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: Use of prescription meds, nutritional supplements, OTC medications. New or unusually strenuous exercise for the duration of the trial. Current or previous drug or alcohol abuse. Current, or previous smoker within 12 weeks prior to screening. Causal or social smokers are allowed. Previous treatment or clinical trial with a monoclonal antibody 6 months prior to screening. Current participation in any clinical research study. ECG QTcF greater than or equal to 450 msec. Greater than 6.4% glycosylated hemoglobin (HgbA1c) at screening Fasting blood glucose greater than or equal to 126 mg/dL (7 mmol/L) at screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A Cohort 1-8<br>ALD1910/Placebo; Single Dose IV infusion on Day 1 | Biological: ALD1910<br>* Single Dose IV infusion<br>|
| Experimental: Part B Cohort 9<br>ALD1910/Placebo+Sumatriptan; Single Dose IV infusion on Day 1 | Biological: ALD1910<br>* Single Dose IV infusion<br>Biological: Sumatriptan<br>* Single dose subcutaneous injection<br>|
| Experimental: Part B Cohort 10<br>ALD1910/Placebo; Single dose subcutaneous injection on Day 1 | Biological: ALD1910<br>* Single dose subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Number of anti-ALD1910 antibodies (ADA) and characterization of anti-ALD1910 ADA positive responses for neutralizing activity | From dosing to week 20 |