NCT07016633

To Evaluate the Tolerability, Pharmacokinetics, and Pharmacodynamics of IMM-H014 in Patients With MASH

A Phase Ib/IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics, and Pharmacodynamics of IMM-H014 Consecutive Multiple Treatment for 12 Weeks in Adult Patients With MASH

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Changchun Intellicrown Pharmaceutical Co. LTD · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the tolerability, pharmacokinetics, and pharmacodynamics of consecutive Multiple treatment for 12 weeks（84 Days） in Adult Patients with Metabolic Dysfunction-Associated Steatohepatitis. Participants will receive either IMM-H014 or placebo.

Detailed description

The study is a randomized, double-blind phase Ib/IIa trial. Subjects will receive 125mg, 225mg, 325mg and 400mg (Group 1, Group 2, Group 3 and Group 4). Each group will consist of 10 participants who will be randomly assigned to receive IMM-H014 and placebo in a ratio of 4:1(8 receiving the investigational drug and 2 receiving placebo). Administer D1-D84 on an empty stomach or after breakfast once a day for 84 consecutive days (12 weeks).

Conditions

• Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Interventions

Type	Name	Description
DRUG	IMM-H014	Each group will consist of 10 participants who will be randomly assigned to receive IMM-H014 and placebo in a ratio of 4:1, once a day for a total of 12 weeks.
DRUG	Placebo	Each group will consist of 10 participants who will be randomly assigned to receive IMM-H014 and placebo in a ratio of 4:1, once a day for a total of 12 weeks.

Timeline

• Start date: 2025-06-10
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2025-06-11
• Last updated: 2025-06-13

Locations

1 site across 1 country: China