A Trial to Evaluate KPC000154 Tablets in Healthy Subjects
ConditionHealthy Subjects、Lipid Metabolism
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorKunming Pharmaceuticals, Inc.
About this trial
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KPC000154 Tablets in Healthy Subjects
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- KPC000154 10mg Tablet Intervention
- KPC000154 30mg Tablet Intervention
- KPC000154 60mg Tablet Intervention
- KPC000154 120mg Tablet Intervention
- KPC000154 200mg Tablet Intervention
- KPC000154 300mg Tablet Intervention
- KPC000154 400mg Tablet Intervention
- KPC000154 80mg multiple-dose Tablet Intervention（To Be Determined）
- KPC000154 120mg multiple-dose Tablet Intervention（To Be Determined）
- KPC000154 40mg multiple-dose Tablet Intervention（To Be Determined）
- Placebo-controlled（SAD）
- Placebo-controlled（MAD）
Treatment groups
92 Participants
are divided into 12 treatment groups12
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov