Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04867057
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2021-04-16
Brief Title:
Trichomylin Safety Tolerability Pharmacokinetics in Healthy Adults and First in Human Osteoarthritis Pain Evaluation
Sponsor:
ZYUS Life Sciences Inc
Organization:
ZYUS Life Sciences Inc
Study Overview
Official Title:
A Phase 1 FIH Randomized Double Blind Placebo Controlled SADMAD Study to Assess Safety Tolerability PKPD 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 randomizationdose administration The Screening period was followed by admission to the clinical research unit CRU pre-dose assessment post-dose assessments and a final end of study EOSfollow-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 andor 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 randomizationdose administration The Screening period was followed by admission to the clinical research unit CRU pre-dose assessment post-dose assessments and a final end of study EOSfollow-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 andor 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:
None
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?:
None