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

NCT06243835 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-10-24

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Lohocla Research Corporation

    lead INDUSTRY

Principal Investigators

  • Mark Wallace, MD · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-21
Primary Completion
2024-11-22
Completion
2025-02-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06243835 on ClinicalTrials.gov