Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT07016633
Brief 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).
Study:
NCT07016633
Study Brief:
Protocol Section:
NCT07016633