A Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of DNL343 in Healthy Volunteers

  • STATUS
    Recruiting
  • participants needed
    88
  • sponsor
    Denali Therapeutics Inc.
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Updated on 19 February 2024
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Summary

This is a Phase 1 study carried out at a single site in 88 healthy male subjects and healthy female subjects of non childbearing potential to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of DNL343.

Details
Condition Healthy Volunteers
Age 18years - 50years
Treatment Placebo, DNL343
Clinical Study IdentifierNCT04268784
SponsorDenali Therapeutics Inc.
Last Modified on19 February 2024

Eligibility

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Inclusion Criteria

Women of non-childbearing potential and men; aged 18-50 years, inclusive
BMI 18-32 kg/m, inclusive, and body weight of at least 50 kg

Exclusion Criteria

History of clinically significant neurologic, psychiatric, endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders
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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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