A Study to Investigate the Safety, Tolerability, Pharmacokinetics of ALZ002 DS in Healthy Volunteers

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study, to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses (SAD-MAD) of ALZ002 DS in Healthy Volunteers

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single-ascending and multiple-ascending doses of ALZ002 DS.

Inclusion Criteria:

• Healthy male and/or non-childbearing potential female subjects, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥18 and ≤55 years of age at screening.
• Body mass index > 18.5 and < 30.0 kg/m2, and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening visit.
• Capable of consent.

Exclusion Criteria:

• Any clinically significant abnormality or abnormal laboratory test results
• Positive urine drug screen, alcohol breath test, or urine cotinine test
• History of significant allergic reactions to any drug.
• Participation in a clinical research study involving the administration of an investigational or marketed drug or device
• History of clinically significant opportunistic infection
• Presence of fever (body temperature > 38°C)