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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04392830

Enrollment

Registered

2020-05-19

Start date

2020-05-11

Completion date

2021-06-15

Last updated

2021-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

DRUGALZ002 DS

Administered orally

DRUGPlacebo

Administered orally

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Maximum Plasma Concentration (Cmax) will be assessed	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	Maximum observed plasma concentration (Cmax)
Area Under the Curve (AUC) will be assessed	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 plasma concentration versus time curve

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026