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

  • STATUS
    Recruiting
  • End date
    Feb 10, 2022
  • participants needed
    56
  • sponsor
    ZYUS Life Sciences Inc.
Updated on 19 June 2021

Summary

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.

Description

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).

Details
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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