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

NCT06243835 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: KIND-2022-01UH3DA047680
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Incidence, Severity and Relationship of Adverse Events [Safety and Tolerability]

  Changes in clinical laboratory tests, ECG, fecal occult blood tests, vital signs and urine output

  From baseline to Day 7

Secondary Outcomes (6)

• Pharmacokinetic AUCt of Kindolor Tosylate

  Pre-dose to 48 hours post-dose

• Pharmacokinetic AUC∞ of Kindolor Tosylate

  Pre-dose to 48 hours post-dose

• Pharmacokinetic Cmax of Kindolor Tosylate

  Pre-dose to 48 hours post-dose

• Pharmacokinetic Tmax of Kindolor Tosylate

  Pre-dose to 48 hours post-dose

• Pharmacokinetic λz of Kindolor Tosylate

  Pre-dose to 48 hours post-dose

Study Arms (5)

Kindolor Cohort 1

EXPERIMENTAL

Kindolor Tosylate 1 tablet dose 100mg NPO for 8hrs x1 AM PO ex aq

Drug: Kindolor Tosylate

Kindolor Cohort 2

EXPERIMENTAL

Kindolor Tosylate tablet 1 tablet dose 300mg NPO for 8hrs x1 AM PO ex aq

Drug: Kindolor Tosylate

Kindolor Cohort 3

EXPERIMENTAL

Kindolor Tosylate 3 tablets dose 300mg NPO for 8hrs x1 AM PO ex aq

Drug: Kindolor Tosylate

Kindolor Cohort 4

EXPERIMENTAL

Kindolor Tosylate 6 tablets dose 300mg NPO for 8hrs x1 AM PO ex aq

Drug: Kindolor Tosylate

Placebo Comparator

PLACEBO COMPARATOR

Placebo to Match tablet(s) NPO for 8hrs x1 AM PO ex aq

Drug: Placebo

Interventions

Kindolor Tosylate DRUG

Kindolor Tosylate enteric coated tablets containing the specified amount of drug product

Also known as: DCUKA

Kindolor Cohort 1; Kindolor Cohort 2; Kindolor Cohort 3; Kindolor Cohort 4

Placebo DRUG

Placebo enteric coated tablets identically matched to the Kindolor Tosylate tablets with equal amount of Prosolv SMCC replacing the Kindolor Tosylate

Also known as: Placebo to Match

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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)

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,

Sponsors & Collaborators

• Lohocla Research Corporation: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

The Altman Clinical and Translational Research Institute

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Wallace, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 6, 2024
• Study Start: April 21, 2024
• Primary Completion: November 22, 2024
• Study Completion: February 27, 2025
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)