Double-blind, Placebo-control, Study to Evaluate the Safety and Pharmacokinetics of CT-044 HCl, in Healthy Volunteers

Surgery Clinical Trial

Official title: Double-blinded, Placebo-controlled, Sequential Cohort, Multiple-Dose Escalation Study to Evaluate the Safety and Multiple Dose Pharmacokinetics of CT-044 HCl, a Reactive Species Decomposition Accelerant, in Healthy Human Volunteers

Status Active, not recruiting

Clinical Trial Summary

This study will be conducted to assess safety, tolerability, and PK of CT-044 HCl in normal healthy volunteers, in a traditional sequential multiple ascending dose paradigm. The multiple-dose escalation is designed to mimic the manner in which the product (CT-044 HCl) would be used to manage ongoing pain in patients (i.e., multiple dosing).

Clinical Trial Description

Subjects meeting all inclusion and exclusion criteria will be randomized to receive CT-044 HCl or placebo in three successive dose escalating cohorts of 8 subjects each (2 placebo and 6 active drug per dose level). Subjects will receive multiple oral CT-044 HCl doses for 7 days. Subjects will be monitored in-house for vital signs, physical examination, electrocardiogram (ECG), safety laboratory testing and documentation of adverse signs and symptoms. Serial blood and urine samples will be collected to evaluate CT-044 HCl levels in plasma and urine.

Eligible subjects will be admitted to the Clinical Trial Unit on the day prior to dosing (Day -1) and remain in house until Day 9 (discharge day). Subjects will return to the Clinical Trial Unit on an outpatient basis for follow-up (Day 13, ± 1 day). ;

Related Conditions & MeSH terms

• Acute Pain
• Neuropathy
• Pain, Acute
• Surgery

• NCT number: NCT04175743
• Study type: Interventional
• Source: Lotus Clinical Research, LLC
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: December 4, 2019
• Completion date: September 2020