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