Clinical Trial

To Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of IMM-H014 in Healthy Subjects

Recruiting Phase 1
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Record status
This record was last updated April 11, 2025 (before its estimated June 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of IMM-H014 on fasted condition, and characterize PK of IMM-H014 on an empty stomach (fasted condition) and following a high fat, high calorie meal (fed condition) in a 2-period, 2-sequence manner. The study will be conducted in 3 parts (Ascending single dose, multiple dose and food effect). Participants will receive either IMM-H014 or placebo.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-01-11.
Trial Details
NCT Number NCT06216041
Lead Sponsor Changchun Intellicrown Pharmaceutical Co. LTD
Conditions Nonalcoholic Steatohepatitis (NASH)
Enrollment 138 participants
Start Date 2023-12-06
Primary Completion 2025-06-01 (estimated)
Study Completion 2025-08-01 (estimated)
Updated on ClinicalTrials.gov 2025-04-11