Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633562
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
A Study to Test the Effects of Nezavist At Different Doses in Healthy Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1a Randomized Double-blind Placebo-controlled Single Site Single Ascending Dose Study of the Safety Tolerability and Pharmacokinetics of Nezavist in Healthy Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to determine the safety tolerability and effects of Nezavist in healthy adults The main questions it aims to answer are
What is the safety and maximum tolerated dose MTD of orally administered Nezavist formulated as a spray dried dispersion SDD in healthy volunteers
What are the pharmacokinetics PK of orally administered Nezavist SDD and its major metabolite DCUKA across a range of doses in healthy volunteers
Researchers will compare the active drug Nezavist and a placebo an inactive substance that looks like the drug to see if there is any differences between the two groups to make sure Nezavist is safe to use in future studies for reducing alcohol consumption by individuals that have alcohol use disorder AUD
What is the safety and maximum tolerated dose MTD of orally administered Nezavist formulated as a spray dried dispersion SDD in healthy volunteers
What are the pharmacokinetics PK of orally administered Nezavist SDD and its major metabolite DCUKA across a range of doses in healthy volunteers
Researchers will compare the active drug Nezavist and a placebo an inactive substance that looks like the drug to see if there is any differences between the two groups to make sure Nezavist is safe to use in future studies for reducing alcohol consumption by individuals that have alcohol use disorder AUD
Detailed Description:
Eligible participants will undergo intake procedures and baseline evaluations at the clinic the day before dosing The next day participants will be randomized to and receive either Nezavist SDD oral suspension or placebo vehicle 4 cohorts of escalating doses of Nezavist with 6 Nezavist subjects and 2 placebo subjects in each cohort Participants will remain in the clinic for at least an additional 48-hours for safety assessments and blood collections to determine plasma levels of Nezavist then will be discharged from the clinic and return for follow-up safety tests 72-hours later
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None