Trichomylin Safety Tolerability and Pharmacokinetics in Healthy Adults and First in Human Osteoarthritis Pain Evaluation

  • End date
    Feb 10, 2022
  • participants needed
  • sponsor
    ZYUS Life Sciences Inc.
Updated on 19 June 2021


This is a first in human, randomized, double blind, SAD (with food effect) followed by a MAD study of Trichomylin conducted in healthy adult participants.


The study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of Trichomylin in healthy adult participants.

Up to 56 participants will be enrolled into 1 of 4 SAD cohorts (8 per cohort) and 3 MAD cohorts (8 per cohort). Participants will undergo a Screening period between 21 days and 28 days prior to randomization/dose administration (for SAD and MAD respectively), admission to the clinical research unit (CRU), pre-dose assessment, post-dose assessment, and a final end of study (EOS)/follow-up or early termination (ET) visit (if applicable).

Condition Arthritis, Osteoarthritis, Arthritis and Arthritic Pain, Arthritis and Arthritic Pain (Pediatric), degenerative arthritis
Treatment Placebo for SAD, Placebo for MAD, Trichomylin for SAD, Trichomylin for MAD
Clinical Study IdentifierNCT04867057
SponsorZYUS Life Sciences Inc.
Last Modified on19 June 2021


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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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