NCT06867406

A Trial to Evaluate KPC000154 Tablets in Healthy Subjects

A Phase I, Single-Center, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KPC000154 Tablets in Healthy Adult Volunteers

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Kunming Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Subjects、Lipid Metabolism

Interventions

Type	Name	Description
DRUG	KPC000154 10mg Tablet Intervention	KPC000154 10mg Tablet administered orally in the morning once daily for 1 day
DRUG	KPC000154 30mg Tablet Intervention	KPC000154 30mg Tablet administered orally in the morning once daily for 1 day
DRUG	KPC000154 60mg Tablet Intervention	KPC000154 60mg Tablet administered orally in the morning once daily for 1 day
DRUG	KPC000154 120mg Tablet Intervention	KPC000154 120mg Tablet administered orally in the morning once daily for 1 day
DRUG	KPC000154 200mg Tablet Intervention	KPC000154 200mg Tablet administered orally in the morning once daily for 1 day
DRUG	KPC000154 300mg Tablet Intervention	KPC000154 300mg Tablet administered orally in the morning once daily for 1 day
DRUG	KPC000154 400mg Tablet Intervention	KPC000154 400mg Tablet administered orally in the morning once daily for 1 day
DRUG	KPC000154 80mg 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 80mg tablet administered orally in the morning for 14 days
DRUG	KPC000154 40mg multiple-dose Tablet Intervention（To Be Determined）	KPC000154 120mg tablet administered orally in the morning for 14 days
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）	A placebo used in a multiple-dose study where participants receive either the experimental drug or the placebo.

Timeline

• Start date: 2025-03-07
• Primary completion: 2025-11-30
• Completion: 2026-01-31
• First posted: 2025-03-10
• Last updated: 2025-03-10

Locations

1 site across 1 country: China