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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ALZ002 DS; Drug: Placebo

• Registration Number: NCT04392830
• Lead Sponsor: AnnJi Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-10
• Study Start: 2020-05-11
• Study First Submitted QC: 2020-05-13
• Study First Posted: 2020-05-19
• Primary Completion: 2021-04-28
• Study Completion: 2021-06-15
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-16
• Last Update Posted: 2021-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ALZ002 DS	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.
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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)

Trial Locations

Locations (1)

Cmax clinical research; 🇦🇺 Adelaide, Australia