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

AnnJi Pharmaceutical Co., Ltd.1 site in 1 country72 target enrollmentMay 11, 2020

ConditionsHealthy

InterventionsALZ002 DS Placebo

DrugsALZ002 DS Placebo

Overview

Phase: Phase 1
Intervention: ALZ002 DS
Conditions: Healthy
Sponsor: AnnJi Pharmaceutical Co., Ltd.
Enrollment: 72
Locations: 1
Primary Endpoint: Incidence of SAEs and treatment-related adverse events
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 11, 2020

End Date

June 15, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

AnnJi Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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)

Arms & Interventions

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.

Intervention: ALZ002 DS

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Incidence of SAEs and treatment-related adverse events

Time Frame: Baseline through Study Completion (up to Day 14)

Incidence of SAEs and treatment-related severe AEs

Secondary Outcomes

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)
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)