NCT06243835

A Study to Test the Effects of Kindolor at Different Doses in Healthy Adults

A Phase 1a Randomized, Double-blind, Placebo-controlled, Single Site, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Kindolor Tosylate in Healthy Adults

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Lohocla Research Corporation · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to test Kindolor in healthy adults. The main questions it aims to answer are: * What is the safe dose of Kindolor in healthy volunteers? * How is Kindolor metabolized by the human body? Participants will undergo medical tests before and after receiving Kindolor or a placebo to see if there is any difference between the groups.

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 Kindolor tablets or placebo tablets (4 cohorts of escalating doses of Kindolor with 6 Kindolor participants and 2 placebo participants 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 Kindolor, then will be discharged from the clinic and return for follow-up safety tests 7 days later.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DRUG	Kindolor Tosylate	Kindolor Tosylate enteric coated tablets containing the specified amount of drug product
DRUG	Placebo	Placebo enteric coated tablets identically matched to the Kindolor Tosylate tablets with equal amount of Prosolv SMCC replacing the Kindolor Tosylate

Timeline

• Start date: 2024-04-21
• Primary completion: 2024-11-22
• Completion: 2025-02-27
• First posted: 2024-02-06
• Last updated: 2025-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study