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

Alder BioPharmaceuticals, Inc.0 个研究点目标入组 96 人开始时间: 2019年10月10日最近更新: 2021年3月8日

适应症

试验速览

暂无简介。

•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.

•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

发起方

Alder BioPharmaceuticals, Inc.