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

PHASE1RecruitingINTERVENTIONAL
Enrollment

138

Participants

Timeline

Start Date

December 6, 2023

Primary Completion Date

June 1, 2025

Study Completion Date

August 1, 2025

Conditions
Nonalcoholic Steatohepatitis (NASH)
Interventions
DRUG

IMM-H014

"SAD and MAD adopt sentinel method which 2 healthy subjects first will receive IMM-H014, and if are evaluated to be tolerable, the remaining 8 subjects will be randomly assigned to receive IMM-H014 and placebo in a ratio of 3:1(10 in per experimental Cohort)."

DRUG

Placebo

"SAD and MAD adopt sentinel method which 2 healthy subjects first will receive IMM-H014, and if are evaluated to be tolerable, the remaining 8 subjects will be randomly assigned to receive IMM-H014 and placebo in a ratio of 3:1(10 in per experimental Cohort)."

DRUG

IMM-H014 ( FE)

"FE part is divided into two groups: 8 subjects will receive IMM-H014 and 2 subjects will receive placebo In group A .All 8 subjects will receive IMM-H014 in group B. Group A adopts sentinel method .The treatment in food effect consists of 2 periods."

DRUG

Placebo ( FE)

"FE part is divided into two groups: 8 subjects will receive IMM-H014 and 2 subjects will receive placebo In group A .All 8 subjects will receive IMM-H014 in group B. Group A adopts sentinel method .The treatment in food effect consists of 2 periods."

Trial Locations (1)

Unknown

RECRUITING

The first Bethune hospital of Jilin University, Changchun

All Listed Sponsors
lead

Changchun Intellicrown Pharmaceutical Co. LTD

INDUSTRY