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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChangchun Intellicrown Pharmaceutical Co. LTD

About this trial

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.

Eligibility criteria

Qualifiers

Sign an informed consent form before the experiment and fully understand the content, process, and potential adverse reactions of the experiment;

Voluntarily comply with the experimental requirements and conduct follow-up visits on designated dates, demonstrating good adherence to the protocol; And voluntarily maintain the original lifestyle (diet and exercise habits) during the study period without changing.

Participants (including partners) agree to take effective contraceptive measures throughout the study period until 6 months after discontinuation of medication;

Male and female patients aged 18 to 65 years old (including 18 and 65 years old);

Disqualifiers

Excessive alcohol consumption for three consecutive months or more within the year prior to screening (men consume an average of over 30 grams of ethanol per day, equivalent to 3.75 units of alcohol, and women consume over 20 grams, equivalent to 2.5 units of alcohol: 1 unit=285 mL of beer, 25 mL of spirits, or 100 mL of wine);

Individuals with allergies (to multiple drugs or foods);

Donate blood or experience significant blood loss (>450 mL) within the first three months of screening;

Individuals with a history of weight loss surgery or those who are planning to undergo weight loss surgery recently;

Trial design

Treatments tested in this trial

  • IMM-H014
  • Placebo

Treatment groups

40 Participants
are divided into 4 treatment groups