Healthy Subjects、Lipid MetabolismPhase 1KPC000154NCT06867406
A Trial to Evaluate KPC000154 Tablets in Healthy Subjects
A Phase 1 study testing KPC000154 10mg Tablet Intervention, KPC000154 30mg Tablet Intervention and KPC000154 60mg Tablet Intervention in people with Healthy Subjects、Lipid Metabolism, run by Kunming Pharmaceuticals, Inc. at 1 site in China.
Trial summary
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KPC000154 Tablets in Healthy Subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects、Lipid Metabolism
- What is being tested?
- KPC000154 10mg Tablet Intervention, KPC000154 30mg Tablet Intervention and KPC000154 60mg Tablet Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 7 Mar 2025to 31 Jan 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Subjects must fully understand the purpose, nature, procedures of the trial, and potential adverse reactions, and voluntarily participate as subjects, signing an informed consent form prior to the commencement of any study procedures.
- Healthy male and female subjects aged 18 to 55 years (inclusive of boundary values), with multiple-dose administration trials requiring subjects to have low-density lipoprotein cholesterol (LDL-C) levels that are either close to or at the borderline elevation (i.e., 2.8 mmol/L (110 mg/dL) ≤ LDL-C < 4.1 mmol/L (160 mg/dL)) are eligible for inclusion.
- Male subjects must weigh ≥ 50.0 kg, and female subjects ≥ 45.0 kg; single-dose administration trials require a body mass index (BMI) within the range of 19.0-26.0 kg/m² (inclusive of boundary values), while multiple-dose administration trials require a BMI within the range of 19.0-30.0 kg/m² (inclusive of boundary values).
- Subjects must utilize effective contraceptive measures during the trial period and for six months after the last administration of the investigational drug, and must not plan to conceive, donate sperm, or donate ova.
- Subjects must be capable of effective communication with the investigators and understand and comply with all requirements of this study.
Who cannot join
- Individuals with an allergic constitution (e.g., known allergies to two or more medications or foods), or a history of allergies to KPC000154 or related excipients.
- Individuals with acute illnesses occurring within two weeks prior to screening.
- Individuals who have used any medication (including prescription drugs, over-the-counter drugs, traditional Chinese medicine preparations, and herbal remedies), health supplements, or functional vitamins within two weeks prior to screening.
- Individuals who have used inhibitors or inducers of CYP3A4, CYP2B6, CYP2C8, CYP2C9, or BCRP within one month prior to screening (e.g., inducers-rifampicin, phenobarbital, carbamazepine, phenytoin; inhibitors-itraconazole, voriconazole, tenofovir, ketoconazole, azithromycin, amiodarone, verapamil, sertraline, perphenazine, thioridazine, dapsone, montelukast, quercetin, phenformin, sulfamethoxazole, tinidazole, clarithromycin, ritonavir, gemfibrozil, clopidogrel, fluconazole, icatibant, aspergillus fumigatus toxin C, neomycin, sulfasalazine, curcumin, elvitegravir, cyclosporine A).
- Individuals with a history of chronic or severe diseases affecting the cardiovascular, liver, kidney, respiratory, hematopoietic, lymphatic, endocrine, immune, psychiatric, neurological, or gastrointestinal systems, or individuals with gastrointestinal, liver, kidney, or thyroid diseases that could affect drug absorption or metabolism within one year prior to screening.
- Individuals with a history of photosensitivity, or those currently undergoing antibiotic treatment for acne, or those with a history of or currently suffering from immunodeficiency diseases, lupus erythematosus, or immune dysfunction.
Show all 27Show fewer
- Individuals with abnormal clinical significance in physical examination, vital signs, clinical laboratory tests (blood biochemistry tests with ALT > 1.5 times ULN, or AST > 1.5 times ULN, or total bilirubin > 1.5 times ULN), chest X-ray, cardiac ultrasound (only for multiple-dose trials), abdominal ultrasound (liver, gallbladder, spleen, pancreas, kidneys), and electrocardiogram, as assessed by the investigator (Note: In multiple-dose trials, blood biochemistry tests showing borderline elevations in total cholesterol and triglycerides do not constitute clinically significant abnormalities, i.e., total cholesterol < 6.2 mmol/L (240 mg/dL), triglycerides < 3.4 mmol/L (300 mg/dL)).
- Individuals who cannot abstain from consuming beverages and foods containing caffeine or alcohol (including chocolate, tea, coffee, cola, etc.), or grapefruit, grapefruit products, dragon fruit, mango, pomelo, orange, starfruit, guava, etc., which affect drug metabolism, or individuals who cannot stop smoking from 48 hours before dosing until the end of the trial.
- Individuals with prolonged QTc interval on ECG at screening: males with QTcF > 450 ms or females with QTcF > 470 ms (corrected by Fridericia's formula, calculated as QTcF = QT/(RR^0.33)).
- Individuals with glomerular filtration rate (GFR) < 90 mL/min (calculated using the simplified MDRD formula: males: eGFR = 186 × creatinine (mg/dL)^(-1.154) × age^(-0.203); females: eGFR = 186 × creatinine (mg/dL)^(-1.154) × age^(-0.203) × 0.742); Note: creatinine units are mg/dL, and creatinine results in μmol/L must be converted to mg/dL for calculation, 1 μmol/L = 0.01131 mg/dL.
- Individuals with any disease that increases the risk of gastrointestinal bleeding, such as acute gastritis or gastric and duodenal ulcers.
- Individuals who have undergone major surgical procedures within six months prior to screening (excluding diagnostic surgeries), or those planning to undergo surgery during the study, or those who have undergone surgeries judged by the investigator to affect drug absorption, distribution, metabolism, or excretion.
- Individuals who have received any vaccinations within four weeks prior to screening, or those planning to receive any vaccinations during the trial.
- Individuals who have participated in other clinical trials within three months prior to screening (Note: the end time is defined as the last date of participation in the clinical trial).
- Individuals who have engaged in blood donation within three months prior to screening, or those who have experienced blood loss (excluding menstrual blood loss) totaling 400 mL or more within six months prior to screening.
- Individuals with a history of alcohol consumption, i.e., an average weekly intake exceeding 2 units of alcohol (1 unit = 360 mL of beer or 45 mL of liquor with 40% alcohol content or 150 mL of wine) within one year prior to screening, or those who cannot abstain from alcohol during the trial, or those with alcohol breath test results > 0.0 mg/100 mL.
- Individuals with an average daily smoking rate exceeding 5 cigarettes within three months prior to screening, or those with positive cotinine urine tests.
- Individuals with a history of drug abuse (including non-medical use of various anesthetics and/or psychotropic drugs) within one year prior to screening, or those with positive drug abuse screening (including morphine, methamphetamine, ketamine, ecstasy (MDMA), marijuana (THC), etc.).
- Individuals who cannot tolerate venipuncture/indwelling catheters, or those with difficulties in blood collection, or those with a history of fainting at the sight of blood.
- Individuals with swallowing difficulties, or special dietary requirements, who cannot accept uniform diets.
- Individuals with hereditary fructose intolerance or glucose/galactose absorption disorders, or those with sucrose-isomaltase deficiency.
- Individuals deemed by the investigator to have other conditions unsuitable for inclusion.
- Female subjects who have used oral contraceptives within 30 days prior to screening.
- Female subjects who have used long-acting estrogens or progestins (including progesterone-releasing intrauterine devices) or implant contraceptives within six months prior to screening.
- Female subjects who have engaged in unprotected sexual intercourse with partners within 14 days prior to screening.
- Female subjects with positive pregnancy tests or test results outside the normal range or not within the non-pregnant state range.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
No.49, Huayuan North Road, Haidian District, Beijing City
Beijing, Beijing Municipality, 100191
Dongyang D Dr. Liu Dongyang, PhD, 18610966092, liudongyang@vip.sina.com
About this study
Official title: A Phase I, Single-Center, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KPC000154 Tablets in Healthy Adult Volunteers
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KPC000154 Tablets in Healthy Subjects
Read the detailed description
KPC000154 is a thyroid hormone receptor beta (THR-β) agonist that improves NASH by increasing hepatic fat metabolism and reducing fat toxicity. Preclinical studies have shown that KPC000154 significantly reduces lipid levels and liver fibrosis in animal models.
- Conditions
- Healthy Subjects、Lipid Metabolism
- Being tested
- KPC000154 10mg Tablet Intervention, KPC000154 30mg Tablet Intervention, KPC000154 60mg Tablet Intervention, KPC000154 120mg Tablet Intervention, KPC000154 200mg Tablet Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KPC000154 10mg Tablet InterventionDrug
KPC000154 10mg Tablet administered orally in the morning once daily for 1 day
KPC000154 30mg Tablet InterventionDrug
KPC000154 30mg Tablet administered orally in the morning once daily for 1 day
KPC000154 60mg Tablet InterventionDrug
KPC000154 60mg Tablet administered orally in the morning once daily for 1 day
KPC000154 120mg Tablet InterventionDrug
KPC000154 120mg Tablet administered orally in the morning once daily for 1 day
KPC000154 200mg Tablet InterventionDrug
KPC000154 200mg Tablet administered orally in the morning once daily for 1 day
KPC000154 300mg Tablet InterventionDrug
KPC000154 300mg Tablet administered orally in the morning once daily for 1 day
KPC000154 400mg Tablet InterventionDrug
KPC000154 400mg Tablet administered orally in the morning once daily for 1 day
KPC000154 80mg multiple-dose Tablet Intervention（To Be Determined）Drug
KPC000154 80mg tablet administered orally in the morning for 14 days
KPC000154 120mg multiple-dose Tablet Intervention（To Be Determined）Drug
KPC000154 80mg tablet administered orally in the morning for 14 days
KPC000154 40mg multiple-dose Tablet Intervention（To Be Determined）Drug
KPC000154 120mg tablet administered orally in the morning for 14 days
Placebo-controlled（SAD）Drug
A placebo used in a single-dose study where participants receive either the experimental drug or the placebo.
Placebo-controlled（MAD）Drug
A placebo used in a multiple-dose study where participants receive either the experimental drug or the placebo.
| Study group | Role | What they receive |
|---|---|---|
| Placebo (SAD) | Placebo comparator | A placebo used in a single-dose study where participants receive either the experimental drug or the placebo. Receives: Drug: Placebo-controlled（SAD） |
| Placebo (MAD） | Placebo comparator | A placebo used in a single-dose study where participants receive either the experimental drug or the placebo. Receives: Drug: Placebo-controlled（MAD） |
| KPC000154 10mg Tablet Intervention | Experimental | KPC000154, a thyroid hormone receptor beta (THR-β) agonist, is an investigational drug aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single 10 mg oral dose of KPC000154 tablets in healthy subjects. Receives: Drug: KPC000154 10mg Tablet Intervention |
| KPC000154 30mg Tablet Intervention | Experimental | KPC000154, a thyroid hormone receptor beta (THR-β) agonist, is an investigational drug aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single 10 mg oral dose of KPC000154 tablets in healthy subjects. Receives: Drug: KPC000154 30mg Tablet Intervention |
| KPC000154 60mg Tablet Intervention | Experimental | KPC000154, a thyroid hormone receptor beta (THR-β) agonist, is an investigational drug aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single 10 mg oral dose of KPC000154 tablets in healthy subjects. Receives: Drug: KPC000154 60mg Tablet Intervention |
| KPC000154 120mg Tablet Intervention | Experimental | KPC000154, a thyroid hormone receptor beta (THR-β) agonist, is an investigational drug aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single 10 mg oral dose of KPC000154 tablets in healthy subjects. Receives: Drug: KPC000154 120mg Tablet Intervention |
| KPC000154 200mg Tablet Intervention | Experimental | KPC000154, a thyroid hormone receptor beta (THR-β) agonist, is an investigational drug aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single 10 mg oral dose of KPC000154 tablets in healthy subjects. Receives: Drug: KPC000154 200mg Tablet Intervention |
| KPC000154 300mg Tablet Intervention | Experimental | KPC000154, a thyroid hormone receptor beta (THR-β) agonist, is an investigational drug aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single 10 mg oral dose of KPC000154 tablets in healthy subjects. Receives: Drug: KPC000154 300mg Tablet Intervention |
| KPC000154 400mg Tablet Intervention | Experimental | KPC000154, a thyroid hormone receptor beta (THR-β) agonist, is an investigational drug aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single 10 mg oral dose of KPC000154 tablets in healthy subjects. Receives: Drug: KPC000154 400mg Tablet Intervention |
| KPC000154 40mg multiple-dose Tablet Intervention（To Be Determined） | Experimental | Multiple doses of KPC000154 will be administered to healthy subjects to assess safety, tolerability, pharmacokinetics, and pharmacodynamics. Receives: Drug: KPC000154 40mg multiple-dose Tablet Intervention（To Be Determined） |
| KPC000154 80mg multiple-dose Tablet Intervention（To Be Determined） | Experimental | Multiple doses of KPC000154 will be administered to healthy subjects to assess safety, tolerability, pharmacokinetics, and pharmacodynamics. Receives: Drug: KPC000154 80mg multiple-dose Tablet Intervention（To Be Determined） |
| KPC000154 120mg multiple-dose Tablet Intervention（To Be Determined） | Experimental | Not described Receives: Drug: KPC000154 120mg multiple-dose Tablet Intervention（To Be Determined） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile of KPC000154 after single and multiple oral administration (Cmax)
Maximum plasma concentration (Cmax) of KPC000154
Measured: 12.8 month
Pharmacokinetic profile of KPC000154 after single and multiple oral administration (AUC0-t)
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of KPC000154
Measured: 12.8 month
Pharmacokinetic profile of KPC000154 after single and multiple oral administration (Tmax)
Time to reach maximum plasma concentration (Tmax) of KPC000154
Measured: 12.8 month
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
safety measures
Measured: 12.8 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start7 Mar 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy Subjects、Lipid MetabolismStudies 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
- Model description
- 1.To determine the pharmacokinetic profile and its variability of KPC000154 tablets after single oral administration in healthy subjects. 2.To determine the pharmacokinetic profile and its variability of KPC000154 tablets after multiple oral administrations in healthy subjects.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kunming Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867406
- Sponsor's protocol ID
- KPC000154-C101
- Other IDs
- kyjtcrc
- Acronym
- KPC000154
- Status last verified
- Dec 2024
- First submitted
- 27 Feb 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
https://cmab.yiigle.com/uploads/guide_html/%E9%9D%9E%E9%85%92%E7%B2%BE%E6%80%A7%E8%84%82%E8%82%AA%E6%80%A7%E8%82%9D%E7%97%85%E9%98%B2%E6%B2%BB%E6%8C%87%E5%8D%97(2018%E6%9B%B4%E6%96%B0%E7%89%88).html
Osaki Y, Takasawa M, Doi K, Nishimura H, Iwaki T, Imaizumi M, Oku N, Hatazawa J, Kubo T. Auditory and tactile processing in a postmeningitic deaf-blind patient with a cochlear implant. Neurology. 2006 Sep 12;67(5):887-90. doi: 10.1212/01.wnl.0000234141.72891.13.
PubMed 16966560
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Center, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KPC000154 Tablets in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT06867406
- Acronym / sponsor ID
- KPC000154 / KPC000154-C101
- Conditions
- Healthy Subjects、Lipid Metabolism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Kunming Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Mar 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KPC000154 Tablets in Healthy Subjects
Detailed description
KPC000154 is a thyroid hormone receptor beta (THR-β) agonist that improves NASH by increasing hepatic fat metabolism and reducing fat toxicity. Preclinical studies have shown that KPC000154 significantly reduces lipid levels and liver fibrosis in animal models.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
- Model description
- 1.To determine the pharmacokinetic profile and its variability of KPC000154 tablets after single oral administration in healthy subjects. 2.To determine the pharmacokinetic profile and its variability of KPC000154 tablets after multiple oral administrations in healthy subjects.
| Arm | Type | Receives |
|---|---|---|
| Placebo (SAD) | Placebo comparator | Drug: Placebo-controlled（SAD）A placebo used in a single-dose study where participants receive either the experimental drug or the placebo. |
| Placebo (MAD） | Placebo comparator | Drug: Placebo-controlled（MAD）A placebo used in a single-dose study where participants receive either the experimental drug or the placebo. |
| KPC000154 10mg Tablet Intervention | Experimental | Drug: KPC000154 10mg Tablet InterventionKPC000154, a thyroid hormone receptor beta (THR-β) agonist, is an investigational drug aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single 10 mg oral dose of KPC000154 tablets in healthy subjects. |
| KPC000154 30mg Tablet Intervention | Experimental | Drug: KPC000154 30mg Tablet InterventionKPC000154, a thyroid hormone receptor beta (THR-β) agonist, is an investigational drug aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single 10 mg oral dose of KPC000154 tablets in healthy subjects. |
| KPC000154 60mg Tablet Intervention | Experimental | Drug: KPC000154 60mg Tablet InterventionKPC000154, a thyroid hormone receptor beta (THR-β) agonist, is an investigational drug aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single 10 mg oral dose of KPC000154 tablets in healthy subjects. |
| KPC000154 120mg Tablet Intervention | Experimental | Drug: KPC000154 120mg Tablet InterventionKPC000154, a thyroid hormone receptor beta (THR-β) agonist, is an investigational drug aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single 10 mg oral dose of KPC000154 tablets in healthy subjects. |
| KPC000154 200mg Tablet Intervention | Experimental | Drug: KPC000154 200mg Tablet InterventionKPC000154, a thyroid hormone receptor beta (THR-β) agonist, is an investigational drug aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single 10 mg oral dose of KPC000154 tablets in healthy subjects. |
| KPC000154 300mg Tablet Intervention | Experimental | Drug: KPC000154 300mg Tablet InterventionKPC000154, a thyroid hormone receptor beta (THR-β) agonist, is an investigational drug aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single 10 mg oral dose of KPC000154 tablets in healthy subjects. |
| KPC000154 400mg Tablet Intervention | Experimental | Drug: KPC000154 400mg Tablet InterventionKPC000154, a thyroid hormone receptor beta (THR-β) agonist, is an investigational drug aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single 10 mg oral dose of KPC000154 tablets in healthy subjects. |
| KPC000154 40mg multiple-dose Tablet Intervention（To Be Determined） | Experimental | Drug: KPC000154 40mg multiple-dose Tablet Intervention（To Be Determined）Multiple doses of KPC000154 will be administered to healthy subjects to assess safety, tolerability, pharmacokinetics, and pharmacodynamics. |
| KPC000154 80mg multiple-dose Tablet Intervention（To Be Determined） | Experimental | Drug: KPC000154 80mg multiple-dose Tablet Intervention（To Be Determined）Multiple doses of KPC000154 will be administered to healthy subjects to assess safety, tolerability, pharmacokinetics, and pharmacodynamics. |
| KPC000154 120mg multiple-dose Tablet Intervention（To Be Determined） | Experimental | Drug: KPC000154 120mg multiple-dose Tablet Intervention（To Be Determined） |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects must fully understand the purpose, nature, procedures of the trial, and potential adverse reactions, and voluntarily participate as subjects, signing an informed consent form prior to the commencement of any study procedures.
- Healthy male and female subjects aged 18 to 55 years (inclusive of boundary values), with multiple-dose administration trials requiring subjects to have low-density lipoprotein cholesterol (LDL-C) levels that are either close to or at the borderline elevation (i.e., 2.8 mmol/L (110 mg/dL) ≤ LDL-C < 4.1 mmol/L (160 mg/dL)) are eligible for inclusion.
- Male subjects must weigh ≥ 50.0 kg, and female subjects ≥ 45.0 kg; single-dose administration trials require a body mass index (BMI) within the range of 19.0-26.0 kg/m² (inclusive of boundary values), while multiple-dose administration trials require a BMI within the range of 19.0-30.0 kg/m² (inclusive of boundary values).
- Subjects must utilize effective contraceptive measures during the trial period and for six months after the last administration of the investigational drug, and must not plan to conceive, donate sperm, or donate ova.
- Subjects must be capable of effective communication with the investigators and understand and comply with all requirements of this study.
Key exclusion criteria (27 listed)
- Individuals with an allergic constitution (e.g., known allergies to two or more medications or foods), or a history of allergies to KPC000154 or related excipients.
- Individuals with acute illnesses occurring within two weeks prior to screening.
- Individuals who have used any medication (including prescription drugs, over-the-counter drugs, traditional Chinese medicine preparations, and herbal remedies), health supplements, or functional vitamins within two weeks prior to screening.
- Individuals who have used inhibitors or inducers of CYP3A4, CYP2B6, CYP2C8, CYP2C9, or BCRP within one month prior to screening (e.g., inducers-rifampicin, phenobarbital, carbamazepine, phenytoin; inhibitors-itraconazole, voriconazole, tenofovir, ketoconazole, azithromycin, amiodarone, verapamil, sertraline, perphenazine, thioridazine, dapsone, montelukast, quercetin, phenformin, sulfamethoxazole, tinidazole, clarithromycin, ritonavir, gemfibrozil, clopidogrel, fluconazole, icatibant, aspergillus fumigatus toxin C, neomycin, sulfasalazine, curcumin, elvitegravir, cyclosporine A).
- Individuals with a history of chronic or severe diseases affecting the cardiovascular, liver, kidney, respiratory, hematopoietic, lymphatic, endocrine, immune, psychiatric, neurological, or gastrointestinal systems, or individuals with gastrointestinal, liver, kidney, or thyroid diseases that could affect drug absorption or metabolism within one year prior to screening.
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 |
|---|---|---|
| KPC000154 10mg Tablet InterventionKPC000154 10mg Tablet administered orally in the morning once daily for 1 day | Drug | KPC000154 10mg Tablet Intervention |
| KPC000154 30mg Tablet InterventionKPC000154 30mg Tablet administered orally in the morning once daily for 1 day | Drug | KPC000154 30mg Tablet Intervention |
| KPC000154 60mg Tablet InterventionKPC000154 60mg Tablet administered orally in the morning once daily for 1 day | Drug | KPC000154 60mg Tablet Intervention |
| KPC000154 120mg Tablet InterventionKPC000154 120mg Tablet administered orally in the morning once daily for 1 day | Drug | KPC000154 120mg Tablet Intervention |
| KPC000154 200mg Tablet InterventionKPC000154 200mg Tablet administered orally in the morning once daily for 1 day | Drug | KPC000154 200mg Tablet Intervention |
| KPC000154 300mg Tablet InterventionKPC000154 300mg Tablet administered orally in the morning once daily for 1 day | Drug | KPC000154 300mg Tablet Intervention |
| KPC000154 400mg Tablet InterventionKPC000154 400mg Tablet administered orally in the morning once daily for 1 day | Drug | KPC000154 400mg Tablet Intervention |
| KPC000154 80mg multiple-dose Tablet Intervention（To Be Determined）KPC000154 80mg tablet administered orally in the morning for 14 days | Drug | KPC000154 80mg multiple-dose Tablet Intervention（To Be Determined） |
| KPC000154 120mg multiple-dose Tablet Intervention（To Be Determined）KPC000154 80mg tablet administered orally in the morning for 14 days | Drug | KPC000154 120mg multiple-dose Tablet Intervention（To Be Determined） |
| KPC000154 40mg multiple-dose Tablet Intervention（To Be Determined）KPC000154 120mg tablet administered orally in the morning for 14 days | Drug | KPC000154 40mg multiple-dose Tablet Intervention（To Be Determined） |
| Placebo-controlled（SAD）A placebo used in a single-dose study where participants receive either the experimental drug or the placebo. | Drug | Placebo (SAD) |
| Placebo-controlled（MAD）A placebo used in a multiple-dose study where participants receive either the experimental drug or the placebo. | Drug | Placebo (MAD） |
Primary outcome
Pharmacokinetic profile of KPC000154 after single and multiple oral administration (Cmax)
Time frame: 12.8 month
Maximum plasma concentration (Cmax) of KPC000154
Pharmacokinetic profile of KPC000154 after single and multiple oral administration (AUC0-t)
Time frame: 12.8 month
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of KPC000154
Pharmacokinetic profile of KPC000154 after single and multiple oral administration (Tmax)
Time frame: 12.8 month
Time to reach maximum plasma concentration (Tmax) of KPC000154
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 12.8 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Results publicationhttps://cmab.yiigle.com/uploads/guide_html/%E9%9D%9E%E9%85%92%E7%B2%BE%E6%80%A7%E8%84%82%E8%82%AA%E6%80%A7%E8%82%9D%E7%97%85%E9%98%B2%E6%B2%BB%E6%8C%87%E5%8D%97(2018%E6%9B%B4%E6%96%B0%E7%89%88).html
- Results publication: PubMed 16966560Osaki Y, Takasawa M, Doi K, Nishimura H, Iwaki T, Imaizumi M, Oku N, Hatazawa J, Kubo T. Auditory and tactile processing in a postmeningitic deaf-blind patient with a cochlear implant. Neurology. 2006 Sep 12;67(5):887-90. doi: 10.1212/01.wnl.0000234141.72891.13.
- Guidelines for the prevention and treatment of non-alcoholic fatty liver diseaseLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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RecruitingPhase 1
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4954 in Healthy Adult Participants With or Without Elevated Lipoprotein (a) (Lp[a]) Levels, and Participants With Dyslipidemia
Healthy Participants, Dyslipidemia
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
Not yet recruitingPhase 1
A Phase 1 Study of VELA-101 in Adult Participants
Healthy Participants, Hyperlipidemia
Not yet recruitingPhase 1
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-10582 in Healthy Subjects and Subjects With Mildly Elevated LDL-C Levels
Dyslipidemia
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.
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 KPC000154 10mg Tablet Intervention, KPC000154 30mg Tablet Intervention and KPC000154 60mg Tablet Intervention in people with Healthy Subjects、Lipid Metabolism, run by Kunming Pharmaceuticals, Inc. at 1 site in China.
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 5 inclusion and 27 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: opening soon, as of the sponsor's last update on 10 Mar 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dongyang D Dr. Liu Dongyang, PhD (18610966092, liudongyang@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic profile of KPC000154 after single and multiple oral administration (Cmax) (time frame: 12.8 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06867406, which also lists 2 linked publications.
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 10 Mar 2025.