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

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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: ALZ002 DS
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALZ002 DS<br>SAD: 6 cohorts of subjects are planned to be orally dosed, ranging from 15 mg - 800 mg. MAD: 3 cohorts of subjects are planned to be orally dosed once or twice daily for 7 consecutive days, ranging from 300 mg - 600 mg. | Drug: ALZ002 DS<br>* Administered orally<br>* Other names: JM17;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of SAEs and treatment-related adverse events | Incidence of SAEs and treatment-related severe AEs | Baseline through Study Completion (up to Day 14) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) will be assessed | Maximum observed plasma concentration (Cmax) | predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose; Day 3: predose; Day 4:predose; Day 5:predose; Day 6: predose; Day7: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose | 
| Area Under the Curve (AUC) will be assessed | Area under the plasma concentration versus time curve | predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose; Day 3: predose; Day 4:predose; Day 5:predose; Day 6: predose; Day7: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose |