Chronic PainPhase 1NCT06243835
A Study to Test the Effects of Kindolor at Different Doses in Healthy Adults
A Phase 1 study testing Kindolor Tosylate in people with Chronic Pain, run by Lohocla Research Corporation at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Kindolor Tosylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2024to 27 Feb 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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),
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- 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.
- Use of any known strong CYP3A4 inhibitors (e.g., ketoconazole) or dual CYP3A4 and 2C9 inhibitor (eg. Fluconazole), or dual CYP3A4 and 2C9 inducer (eg. Rifampin), or use of any monoamine oxidase inhibitors (MAOIs) within 1 month prior to study drug administration.
- Receipt of any drug by injection within 30 days prior to study drug administration.
- History of head trauma with loss of consciousness, history of epilepsy, seizures or convulsions, including febrile, alcohol, or drug withdrawal seizures.
- A clinically notable vital sign abnormality including a history of syncopal or near syncopal events following abrupt change in posture.
- Have any of the following at screening or baseline:
- Blood pressure: systolic >140 mmHg, diastolic >90 mmHg at Screening or Day -1.
- Heart rate: >100 beats/minute at screening or Day -1
- History of cardiovascular abnormality, including left ventricular dysfunction, sick sinus syndrome, family history of long-QT syndrome, or unexplained sudden deaths in their family.
- Has a clinically significant abnormal ECG or an ECG with a QTc interval corrected for heart rate using the Fridericia formula (QTcF) > 430 msec.
- History of gastric surgery, vagotomy, bowel resection, or any surgical procedure that might interfere with gastrointestinal motility, pH, or absorption.
- Has an estimated creatinine clearance (CrCl) outside of normal range.
- Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration.
- Receipt of any investigational product within 6 weeks prior to study drug administration.
- Consumption of alcohol within the 1-day period prior to study drug administration.
- Consumption of grapefruit or grapefruit products from 3 days prior to study drug administration to study drug administration.
- Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.
- Current enrollment in another clinical study.
- Previous enrollment in this study.
- Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive kindolor tosylate.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Altman Clinical and Translational Research Institute
La Jolla, California, 92037
About this study
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
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.
Read the 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
- Being tested
- Kindolor Tosylate, Placebo
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kindolor TosylateDrug
Also called DCUKA
Kindolor Tosylate enteric coated tablets containing the specified amount of drug product
PlaceboDrug
Also called Placebo to Match
Placebo enteric coated tablets identically matched to the Kindolor Tosylate tablets with equal amount of Prosolv SMCC replacing the Kindolor Tosylate
| Study group | Role | What they receive |
|---|---|---|
| Kindolor Cohort 1 | Experimental | Kindolor Tosylate
1 tablet dose 100mg NPO for 8hrs x1 AM PO ex aq Receives: Drug: Kindolor Tosylate |
| Kindolor Cohort 2 | Experimental | Kindolor Tosylate tablet
1 tablet dose 300mg NPO for 8hrs x1 AM PO ex aq Receives: Drug: Kindolor Tosylate |
| Kindolor Cohort 3 | Experimental | Kindolor Tosylate
3 tablets dose 300mg NPO for 8hrs x1 AM PO ex aq Receives: Drug: Kindolor Tosylate |
| Kindolor Cohort 4 | Experimental | Kindolor Tosylate
6 tablets dose 300mg NPO for 8hrs x1 AM PO ex aq Receives: Drug: Kindolor Tosylate |
| Placebo Comparator | Placebo comparator | Placebo to Match tablet(s) NPO for 8hrs x1 AM PO ex aq Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Treatment-emergent adverse events (TEAEs) were assessed starting after the first administration of investigational product until the final follow-up visit. A TEAE is defined as any AE that started or worsened in severity after the first dose of investigational product.
Measured: From Day 1 to Day 7
Secondary outcomes (6)
Pharmacokinetic AUCt of Kindolor Tosylate
Area under the plasma concentration-time (AUCt) curve from time 0 to the time (t) of last quantifiable concentration (Ct).
Measured: Up to 48 hours post-dose
Pharmacokinetic AUC∞ of Kindolor Tosylate
Area under the plasma concentration-time curve (AUC∞) from time 0 extrapolated to infinity.
Measured: Up to 48 hours post-dose
Pharmacokinetic Cmax of Kindolor Tosylate
The maximum observed plasma concentration.
Measured: Up to 48 hours post-dose
Pharmacokinetic Tmax of Kindolor Tosylate
The observed time to reach maximum plasma concentration.
Measured: Up to 48 hours post-dose
Pharmacokinetic λz of Kindolor Tosylate
The terminal-phase exponential rate constant.
Measured: Up to 48 hours post-dose
Pharmacokinetic t1/2 of Kindolor Tosylate
The apparent terminal exponential half-life.
Measured: Up to 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start21 Apr 2024
- Primary completion22 Nov 2024
- Study completion27 Feb 2025
Why it stopped: Terminated by sponsor due to low drug bioavailability; no safety concerns were noted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lohocla Research Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Mark Wallace, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243835
- Sponsor's protocol ID
- KIND-2022-01
- Other IDs
- UH3DA047680
- Status last verified
- Mar 2026
- First submitted
- 29 Jan 2024
- Last updated
- 27 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06243835
- Acronym / sponsor ID
- KIND-2022-01
- Conditions
- Chronic Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated by sponsor due to low drug bioavailability; no safety concerns were noted.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Lohocla Research CorporationIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 21 Apr 2024 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 6 Feb 2024 (actual)
- Results
- Posted 27 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Kindolor Cohort 1 | Experimental | Drug: Kindolor TosylateKindolor Tosylate 1 tablet dose 100mg NPO for 8hrs x1 AM PO ex aq |
| Kindolor Cohort 2 | Experimental | Drug: Kindolor TosylateKindolor Tosylate tablet 1 tablet dose 300mg NPO for 8hrs x1 AM PO ex aq |
| Kindolor Cohort 3 | Experimental | Drug: Kindolor TosylateKindolor Tosylate 3 tablets dose 300mg NPO for 8hrs x1 AM PO ex aq |
| Kindolor Cohort 4 | Experimental | Drug: Kindolor TosylateKindolor Tosylate 6 tablets dose 300mg NPO for 8hrs x1 AM PO ex aq |
| Placebo Comparator | Placebo comparator | Drug: PlaceboPlacebo to Match tablet(s) NPO for 8hrs x1 AM PO ex aq |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- 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:
- 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:
Key exclusion criteria (44 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kindolor TosylateAlso: DCUKAKindolor Tosylate enteric coated tablets containing the specified amount of drug product | Drug | Kindolor Cohort 1, Kindolor Cohort 2, Kindolor Cohort 3, Kindolor Cohort 4 |
| PlaceboAlso: Placebo to MatchPlacebo enteric coated tablets identically matched to the Kindolor Tosylate tablets with equal amount of Prosolv SMCC replacing the Kindolor Tosylate | Drug | Placebo Comparator |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From Day 1 to Day 7
Treatment-emergent adverse events (TEAEs) were assessed starting after the first administration of investigational product until the final follow-up visit. A TEAE is defined as any AE that started or worsened in severity after the first dose of investigational product.
6 secondary outcomes
Pharmacokinetic AUCt of Kindolor Tosylate
Time frame: Up to 48 hours post-dose
Pharmacokinetic AUC∞ of Kindolor Tosylate
Time frame: Up to 48 hours post-dose
Pharmacokinetic Cmax of Kindolor Tosylate
Time frame: Up to 48 hours post-dose
Pharmacokinetic Tmax of Kindolor Tosylate
Time frame: Up to 48 hours post-dose
Pharmacokinetic λz of Kindolor Tosylate
Time frame: Up to 48 hours post-dose
Pharmacokinetic t1/2 of Kindolor Tosylate
Time frame: Up to 48 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Wallace, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Kindolor Tosylate in people with Chronic Pain, run by Lohocla Research Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: From Day 1 to Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.