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

  • STATUS
    Recruiting
  • participants needed
    72
  • sponsor
    Allianz Pharmascience Limited
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Updated on 15 February 2024
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Summary

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

Details
Condition Healthy
Age 18years - 55years
Treatment Placebo, ALZ002 DS
Clinical Study IdentifierNCT04392830
SponsorAllianz Pharmascience Limited
Last Modified on15 February 2024

Eligibility

 Yes No Not Sure

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)
Clear my responses
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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