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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: ALZ002 DS

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, 5000
    • CMAX Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Administered orally
Experimental: ALZ002 DS; 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; Administered orally; Other Names: JM17

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AnnJi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2020
• Primary Completion (Actual): April 28, 2021
• Study Completion (Actual): June 15, 2021

Study Registration Dates

• First Submitted: May 10, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: ALZ002-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No