Safety, Tolerability and Pharmacokinetics of ALD1910

Phase 1

Completed

• Conditions: Migraine; Neurological - Other neurological disorders

• Registration Number: ACTRN12619001380189
• Lead Sponsor: Alder BioPharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-10
• Study Completion: 2020-08-19
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified