A Phase 1 interventional study of KPC000154 10mg Tablet Intervention and KPC000154 30mg Tablet Intervention in Healthy Subjects、Lipid Metabolism, sponsored by Kunming Pharmaceuticals, Inc.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-10.
Sponsored by Kunming Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KPC000154 Tablets in Healthy Subjects
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.
Kunming Pharmaceuticals, Inc. is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A placebo used in a single-dose study where participants receive either the experimental drug or the placebo.
Drug: Placebo-controlled(SAD)
A placebo used in a single-dose study where participants receive either the experimental drug or the placebo.
Drug: Placebo-controlled(MAD)
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.
Drug: KPC000154 10mg Tablet Intervention
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.
Drug: KPC000154 30mg Tablet Intervention
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.
Drug: KPC000154 60mg Tablet Intervention
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.
Drug: KPC000154 120mg Tablet Intervention
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.
Drug: KPC000154 200mg Tablet Intervention
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.
Drug: KPC000154 300mg Tablet Intervention
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.
Drug: KPC000154 400mg Tablet Intervention
Multiple doses of KPC000154 will be administered to healthy subjects to assess safety, tolerability, pharmacokinetics, and pharmacodynamics.
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.
Drug: KPC000154 80mg multiple-dose Tablet Intervention(To Be Determined)
Drug: KPC000154 120mg multiple-dose Tablet Intervention(To Be Determined)
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.
Pharmacokinetic profile of KPC000154 after single and multiple oral administration (Cmax)
Maximum plasma concentration (Cmax) of KPC000154
Time frame: 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
Time frame: 12.8 month
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
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
safety measures
Time frame: 12.8 month
Plan to share: Yes
Supporting information: Study protocol, Icf
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Kunming Pharmaceuticals, Inc.