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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Chronic Pain

In brief

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.

Key facts

Study ID

NCT06243835

Run by

Lohocla Research Corporation

People needed

16

Starts

2024-04-21

Expected to finish

2025-02-27

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male or female volunteer, ages 18-to-55 years, inclusive.
• 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.
• 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).
• 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)
• 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)
• 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.
• If male, agree to not donate sperm from the time of consenting to the study and for 90 days after dosing the study drug.
• 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.
• Complete all assessments required at screening and baseline and be available to stay in the Phase I unit for a period of approximately 3 days and 2 nights and return for a follow-up visit.
• Provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the subject in case of a missed clinic appointment.
• Be someone who in the opinion of the investigator would be expected to complete the study protocol.

You may not qualify if…

• History of significant sensitivity to any drug.
• Requirement for any over-the-counter and/or prescription medication, vitamins and/or herbal supplements (including cannabis and cannabis derived products, including CBD-containing products) on a regular basis or use of any of the above within the 2 weeks or 5 half-lives of the respective medication prior to study drug administration.
• More than moderate alcohol consumption in the past 8 weeks. Moderate alcohol consumption is defined as limiting intake to 2 drinks or less in a day for men and 1 drink or less per day for women. Examples of one drink include: Beer: 12 fluid ounces (355 milliliters); Wine: 5 fluid ounces (148 milliliters); Distilled spirits (80 proof): 1.5 fluid ounces (44 milliliters).
• Has a clinically significant laboratory test that is out of range of normal limits. An out of range of normal limit laboratory value is clinically significant if associated with one of the following: a) clinical diagnosis; b) systemic signs and symptoms; c) physical exam finding; d) more than 10% above the upper or below the lower limit of normal.
• Have a urine toxicology screen positive during screening or baseline for any of the following substances:
• ethylglucuronide (alcohol metabolite),
• amphetamines,
• barbiturates,
• benzodiazepines,
• buprenorphine,
• cocaine,
• fentanyl,
• methylenedioxymethamphetamine (MDMA),
• methadone,
• methamphetamines,
• morphine,
• opioids,
• oxycodone,
• phencyclidine and/or
• tetrahydrocannabinol (THC)
• If female, positive pregnancy test or nursing.
• Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCV Ab) or HIV antibodies (HIV Ab). Negative HIV status will be confirmed at Screening, and the results will be maintained confidentially by the study site.
• Positive SARS-CoV-2 antigen test prior to 72 hours of clinic intake.
• History of any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, endocrine, dermatological, metabolic, neurological (nerve injury) or psychiatric disease or disorder, or any uncontrolled medical illness.
• History of gastroesophageal reflux disease, gastrointestinal ulcers, gastrointestinal bleeding, inflammatory bowel disease or gastroesophageal surgery.

Where it is running

• The Altman Clinical and Translational Research Institute — La Jolla, California, United States

Full record on ClinicalTrials.gov

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