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

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

Recruiting
18-55 years
All
Phase 1

Overview

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

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 > 38C)

Study details
    Healthy

NCT04392830

Allianz Pharmascience Limited

16 February 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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