Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • KPC000154 10mg Tablet Intervention

    Drug

    KPC000154 10mg Tablet administered orally in the morning once daily for 1 day

  • KPC000154 30mg Tablet Intervention

    Drug

    KPC000154 30mg Tablet administered orally in the morning once daily for 1 day

  • KPC000154 60mg Tablet Intervention

    Drug

    KPC000154 60mg Tablet administered orally in the morning once daily for 1 day

  • KPC000154 120mg Tablet Intervention

    Drug

    KPC000154 120mg Tablet administered orally in the morning once daily for 1 day

  • KPC000154 200mg Tablet Intervention

    Drug

    KPC000154 200mg Tablet administered orally in the morning once daily for 1 day

  • KPC000154 300mg Tablet Intervention

    Drug

    KPC000154 300mg Tablet administered orally in the morning once daily for 1 day

  • KPC000154 400mg Tablet Intervention

    Drug

    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.

Treatment groups

92 Participants
are divided into 12 treatment groups

12

Treatment groups

See each treatment group below.

Group A: Placebo (SAD)Placebo comparator 1 intervention
Group B: Placebo (MAD）Placebo comparator 1 intervention
Group C: KPC000154 10mg Tablet InterventionExperimental treatment 1 intervention
Group D: KPC000154 30mg Tablet InterventionExperimental treatment 1 intervention
Group E: KPC000154 60mg Tablet InterventionExperimental treatment 1 intervention
Group F: KPC000154 120mg Tablet InterventionExperimental treatment 1 intervention
Group G: KPC000154 200mg Tablet InterventionExperimental treatment 1 intervention
Group H: KPC000154 300mg Tablet InterventionExperimental treatment 1 intervention
Group I: KPC000154 400mg Tablet InterventionExperimental treatment 1 intervention
Group J: KPC000154 40mg multiple-dose Tablet Intervention（To Be Determined）Experimental treatment 1 intervention
Group K: KPC000154 80mg multiple-dose Tablet Intervention（To Be Determined）Experimental treatment 1 intervention
Group L: KPC000154 120mg multiple-dose Tablet Intervention（To Be Determined）Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pharmacokinetic profile of KPC000154 after single and multiple oral administration (Cmax)

Maximum plasma concentration (Cmax) of KPC000154

Time frame
12.8 month
2

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

Time frame
12.8 month
3

Pharmacokinetic profile of KPC000154 after single and multiple oral administration (Tmax)

Time to reach maximum plasma concentration (Tmax) of KPC000154

Time frame
12.8 month

Secondary outcomes

1

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

safety measures

Time frame
12.8 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kunming Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: