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

TerminatedPhase 1NCT06243835
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
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
Conditions
Interventions
Sponsor
Lohocla Research Corporation
Collaborators
National Institute on Drug Abuse (NIDA)
Start date
2024-04-21
Primary completion
2024-11-22
Sex
All
Age range
from 18 Years to 55 Years
Healthy volunteers
true
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Healthy male or female volunteer, ages 18-to-55 years, inclusive. 2. BMI must be between 18 and 32 kg/m2 (inclusive) and weigh a minimum of 50 kg (110 lbs). BMI is calculated as weight in kg divided by the square of height measured in meters. 3. A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG). 4. If female, be postmenopausal (at least 2 years prior to dosing), surgically sterile (6 months post tubal ligation), or agree to use an acceptable form of birth control from screening until 28 days after dosing. Subjects who claim postmenopausal status will have status confirmed with a follicle-stimulating hormone (FSH) test. Acceptable forms of birth control for females include the following: * Vasectomized partner (at least 6 months prior to dosing) * Surgical sterilization (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) at least 6 months prior to dosing * Non-surgical permanent sterilization (eg, Essure procedure) at least 3 months prior to dosing * Double barrier (diaphragm with spermicide; condoms with spermicide) * Nonhormonal intrauterine device * Abstinence (must agree to use a double barrier method if they become sexually active during the study) 5. If male, agree to use an acceptable method of birth control during the study and in the 90 days following dosing. Acceptable forms of birth control for males include the following: * Vasectomy (at least 6 months before dosing) * Partner is surgically sterilized (see methods above for females) * Partner uses oral, injectable, or implantable hormonal contraceptives or intrauterine device (IUD) * Double barrier (partner uses diaphragm with spermicide; condoms with spermicide) * Abstinence (subject must agree to use a double barrier method if subject becomes sexually active during the study) 6. If female, agree to not breastfeed or donate ova from the time of consenting to the study and for 28 days after dosing the study drug. 7. If male, agree to not donate sperm from the time of consenting to the study and for 90 days after dosing the study drug. 8. Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English. 9. Complete all assessments required at screening and baseline and be available to stay in t…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06243835