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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04392830
• Other study ID #: ALZ002-101
• Status: Completed
• Phase: Phase 1
• Start date: May 11, 2020
• Est. completion date: June 15, 2021

Study information

• Verified date: August 2021
• Source: Allianz Pharmascience Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 15, 2021
• Est. primary completion date: April 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ALZ002 DS
Administered orally
• Placebo
Administered orally

Locations

Country	Name	City	State
Australia	Cmax clinical research	Adelaide

Sponsors (1)

Lead Sponsor	Collaborator
Allianz Pharmascience Limited

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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