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Safety, Tolerability, and Pharmacokinetics of CSX-1004

Opioid Use Disorder Clinical Trial

Official title:
A Phase 1a, Randomized, Double-Blind, Placebo-Controlled, Single Site, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of CSX-1004 Injection in Healthy Adults

Clinical Trial Summary

This is a Phase 1a, randomized, double-blind, single ascending dose study, designed to assess the safety, tolerability, and PK of a single CSX-1004 injection, administered by IV infusion across a range of doses in healthy adult subjects. The study will have 3 phases: Screening, Inpatient Treatment, and Outpatient Follow-up. The primary objective of the study is to determine the safety and tolerability of CSX-1004 Injection administered by intravenous (IV) infusion across a range of doses in healthy adult subjects. The secondary objective of the study is to determine the pharmacokinetics (PK) of CSX-1004 Injection administered by IV infusion across a range of doses in healthy adult subjects.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06005402
Study type Interventional
Source Cessation Therapeutics, Inc.
Contact Brandi Eckard
Phone 913-333-3000
Email breckard@drvince.com
Status Recruiting
Phase Phase 1
Start date August 1, 2023
Completion date May 2024
View Details
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