drugset
drugset / Trial / NCT06216041

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

NCT06216041 ↗

Phase 1 Recruiting 138 enrolled Changchun Intellicrown Pharmaceutical Co. LTD
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2023-12-06
Primary completion
2025-06-01
Completion
2025-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject IMM-H014 Unknown 12.5 mg Oral
Subject IMM-H014 Unknown 37.5 mg Oral
Subject IMM-H014 Unknown 75 mg Oral
Subject IMM-H014 Unknown 125 mg Oral
Subject IMM-H014 Unknown 175 mg Oral
Subject IMM-H014 Unknown 225 mg Oral
Subject IMM-H014 Unknown 275 mg Oral
Subject IMM-H014 Unknown 325 mg Oral

Indications

metabolic dysfunction-associated steatohepatitis