Phase 1 Study of ANAVEX3-71

  • STATUS
    Recruiting
  • participants needed
    36
  • sponsor
    Anavex Life Sciences Corp.
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Updated on 19 February 2024
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electrocardiogram
12 lead electrocardiogram

Summary

A first in human phase 1 study in healthy volunteers to assess ANAVEX3-71 safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics

Description

This is a first-in-human Phase 1 study designed to investigate the safety, tolerability, PK, PD and bioavailability of orally administered ANAVEX3-71 in healthy volunteers

Details
Condition Healthy
Age 18years - 35years
Treatment Placebo, ANAVEX3-71
Clinical Study IdentifierNCT04442945
SponsorAnavex Life Sciences Corp.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Healthy, male or female between 18 and 55 years of age, inclusive
Body mass index (BMI) between 19-28 kg/m2 and within a body weight of 60 kg and 120 kg
Female subjects must be of non-childbearing potential (defined as postmenopausal for at least 2 years or surgically sterile at least 6 months prior to dosing) or must be using adequate contraception
Subject is judged by the investigator to be in generally good health at screening based upon the results of a medical history, physical examination, laboratory profile, and 12-lead electrocardiogram (ECG)
Non-smoker (no tobacco use within past 3 months)
Subject is willing to comply with the study protocol, in the investigator's judgement

Exclusion Criteria

Subject has a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, dermatological, neurological, psychiatric, hematological (including myelosuppression and bleeding disorders) or immunological/autoimmune disorder(s), and/or any condition that could constitute a potential safety risk factor or could alter the absorption, distribution, metabolism or elimination of the study drugs
Positive test result on Hepatitis B surface antigen (HBsAg) or is Hepatitis C virus antibody (HCV-Ab) positive or positive HIV-1 and/or -2 serology
Subject has a history of chronic alcohol abuse within the last 2 years, or has a positive alcohol test or is known to have excessive alcohol intake
History of substance abuse, known drug addiction, or positive test for drugs of abuse
Subject has participated in another clinical trial of an investigational drug (or a medical device) within the last 3 months or is currently participating in another trial of an investigational drug (or a medical device)
Female subject who is pregnant or lactating or planning a pregnancy
A history of major mental illness that in the opinion of the Investigator may affect the ability of the subject to participate in the study (psychosis is to be disqualified)
Subject has a condition the Investigator believes would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk
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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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