NCT04867057

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

A Phase 1 FIH, Randomized, Double Blind, Placebo Controlled, SAD/MAD Study to Assess Safety, Tolerability, PK/PD and Food Effect of Trichomylin in Healthy Adult Participants and Preliminary Efficacy in Management of Chronic OA Pain

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: ZYUS Life Sciences Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

The study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of Trichomylin® in healthy adult participants. A total of up to 40 participants were planned to be enrolled into Part A and Part B of the study. Part A consisted of 3 SAD cohorts (n = 8 per cohort) and Part B consisted of 2 MAD cohorts (n = 8 per cohort). Participants underwent a Screening period beginning up to 21 days for the SAD cohorts and 28 days for the MAD cohorts prior to randomization/dose administration. The Screening period was followed by admission to the clinical research unit (CRU), pre-dose assessment, post-dose assessment(s), and a final end of study (EOS)/follow-up visit. Safety and tolerability endpoints are to report the percentage and severity of unexpected or serious adverse events, including clinically significant vital signs, laboratory test results, physical examination, and/or reported clinical symptoms, and use of concomitant medications. Other endpoints to be assessed are neurocognitive impairment, altered state of consciousness, and overall well-being. Other assessments include pharmacokinetic (fasted and fed states) and pharmacodynamic endpoints.

Conditions

• Healthy
• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Trichomylin for SAD	Healthy subjects meeting eligibility criteria were randomized to each dose cohort (up to four dose ascending cohorts) to receive either Trichomylin or Placebo. The study drug (Trichomylin or Placebo) will be administered orally as a single dose.
DRUG	Placebo for SAD	Healthy subjects meeting eligibility criteria were randomized to each dose cohort (up to four dose ascending cohorts) to receive either Trichomylin or Placebo. The study drug (Trichomylin or Placebo) will be administered orally as a single dose.
DRUG	Trichomylin for MAD	Healthy subjects meeting eligibility criteria were randomized to each dose cohort (up to three cohorts) to receive either Trichomylin or Placebo. The study drug (Trichomylin or Placebo) will be administered daily oral doses for a total of 9 days.
DRUG	Placebo for MAD	Healthy subjects meeting eligibility criteria were randomized to each dose cohort (up to three cohorts) to receive either Trichomylin or Placebo. The study drug (Trichomylin or Placebo) will be administered daily oral doses for a total of 9 days.

Timeline

• Start date: 2021-04-19
• Primary completion: 2022-02-18
• Completion: 2022-05-30
• First posted: 2021-04-30
• Last updated: 2024-06-27

Locations

1 site across 1 country: Australia