Multiple Ascending Dose Study of ALZ-801

• Status: Completed
• Trial end date: 2016-07-04
• Target enrollment: 0
• Participant gender: All

Summary

Phase I, single-center, double-blind, randomized, placebo-controlled, parallel-group study of the safety, tolerability, and pharmacokinetics (PK) in plasma and urine, of multiple ascending doses of ALZ-801 (capsule, Part 1; prototype tablet Part 2) and the primary metabolite in healthy male or female subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alzheon Inc.
• Collaborator: Quotient Clinical

Criteria

Inclusion Criteria:

• Healthy males, and females

• Age: 50-75 years, Part 1; 60-75 years Part 2

• Females must be of non-childbearing potential

• Body Mass Index 18-35 kg/m squared;

• Vital signs normal for age: BP 90-160/40-90 mmHg; HR 50 to 90 bpm)

• No clinically significant electrocardiogram readings

Exclusion Criteria:

• Body weight < 50 kg

• History of any drug or alcohol abuse in the past 2 years

• Subjects known to have a creatinine clearance of <60 mL/min

• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results

• History of clinically significant cardiovascular, pulmonary, chronic respiratory, renal, hepatic, GI, immunologic, endocrine, neurologic, psychiatric or thromboembolic disease

• History of metabolic disturbances;