Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-02 @ 12:55 AM
Study NCT ID:
NCT04867057
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2021-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trichomylin® Safety, Tolerability & Pharmacokinetics in Healthy Adults and First in Human Osteoarthritis Pain Evaluation
Sponsor:
ZYUS Life Sciences Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOPE
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: