A Trial to Evaluate KPC000154 Tablets in Healthy Subjects
KPC000154
A Phase I, Single-Center, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KPC000154 Tablets in Healthy Adult Volunteers
2 other identifiers
interventional
92
1 country
1
Brief Summary
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KPC000154 Tablets in Healthy Subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2025
CompletedStudy Start
First participant enrolled
March 7, 2025
CompletedFirst Posted
Study publicly available on registry
March 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2026
CompletedMarch 10, 2025
December 1, 2024
9 months
February 27, 2025
March 7, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Pharmacokinetic profile of KPC000154 after single and multiple oral administration (Cmax)
Maximum plasma concentration (Cmax) of KPC000154
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
12.8 month
Pharmacokinetic profile of KPC000154 after single and multiple oral administration (Tmax)
Time to reach maximum plasma concentration (Tmax) of KPC000154
12.8 month
Secondary Outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
12.8 month
Study Arms (12)
Placebo (SAD)
PLACEBO COMPARATORA placebo used in a single-dose study where participants receive either the experimental drug or the placebo.
Placebo (MAD）
PLACEBO COMPARATORA placebo used in a single-dose study where participants receive either the experimental drug or the placebo.
KPC000154 10mg Tablet Intervention
EXPERIMENTALKPC000154, 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
EXPERIMENTALKPC000154, 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
EXPERIMENTALKPC000154, 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
EXPERIMENTALKPC000154, 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
EXPERIMENTALKPC000154, 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
EXPERIMENTALKPC000154, 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
EXPERIMENTALKPC000154, 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）
EXPERIMENTALMultiple 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）
EXPERIMENTALMultiple 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）
EXPERIMENTALInterventions
KPC000154 10mg Tablet administered orally in the morning once daily for 1 day
KPC000154 30mg Tablet administered orally in the morning once daily for 1 day
KPC000154 60mg Tablet administered orally in the morning once daily for 1 day
KPC000154 120mg Tablet administered orally in the morning once daily for 1 day
KPC000154 200mg Tablet administered orally in the morning once daily for 1 day
KPC000154 300mg Tablet administered orally in the morning once daily for 1 day
KPC000154 400mg Tablet administered orally in the morning once daily for 1 day
KPC000154 80mg tablet administered orally in the morning for 14 days
KPC000154 80mg tablet administered orally in the morning for 14 days
KPC000154 120mg tablet administered orally in the morning for 14 days
A placebo used in a single-dose study where participants receive either the experimental drug or the placebo.
A placebo used in a multiple-dose study where participants receive either the experimental drug or the placebo.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
- 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.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
No.49, Huayuan North Road, Haidian District, Beijing City
Beijing, Beijing Municipality, 100191, China
Related Publications (2)
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
RESULTOsaki 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.
PMID: 16966560RESULT
Related Links
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2025
First Posted
March 10, 2025
Study Start
March 7, 2025
Primary Completion
November 30, 2025
Study Completion
January 31, 2026
Last Updated
March 10, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- December 25, 2024 (start date)--January 12, 2026(end date)