CompletedPhase 1ACTRN12619001380189

Safety, Tolerability and Pharmacokinetics of ALD1910

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

Sponsor

Alder BioPharmaceuticals, Inc.

Enrollment

96 participants

Start Date

Oct 10, 2019

Study Type

Interventional

Conditions

Migraine

Summary

This is FIH randomized, double-blind, placebo-controlled study in 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.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Inclusion Criteria3

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 Criteria9

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

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Interventions

Part A includes up to 8 dosing cohorts with 8 subjects in each cohort. Each subject receives one dose of ALD1910 or placebo infused into a vein. The ALD1910 dose level increases for each cohort (1 mg, 3 mg, 10 mg, 30 mg, 100 mg, 300 mg, or 1000 mg) if data from each cohort show it is safe to do so. Part B includes 2 dosing cohorts with 16 subjects in each cohort. The dose for Part B will be determined based upon the safety data committee review of all doses tested in part A. In one cohort subjects will receive either ALD1910 or placebo infused into a vein. Subjects will also receive 6 mg sumatriptan injected under the skin 2 hours after the end of the ALD1910 or placebo infused into a vein. In the second cohort subjects receive one dose of ALD1910 or placebo injected under the skin. The ALD1910 dose level is one of the doses tested in Part A and will not exceed 100 mg. Each subject will remain in the study unit until the morning of the 3rd day after dosing (approximately 48 hours post-dose). Subjects will complete 9 additional outpatient visits for safety assessment over 20 weeks.