A Trial to Evaluate KPC000154 Tablets in Healthy Subjects
NCT06867406 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92
Last updated 2025-03-10
Summary
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KPC000154 Tablets in Healthy Subjects
Conditions
- Healthy Subjects、Lipid Metabolism
Interventions
- 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.
Sponsors & Collaborators
-
Kunming Pharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-03-07
- Primary Completion
- 2025-11-30
- Completion
- 2026-01-31
Countries
- China
Study Locations
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