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

Last updated: April 9, 2025
Sponsor: Changchun Intellicrown Pharmaceutical Co. LTD
Overall Status: Active - Recruiting

Phase

1

Condition

Nonalcoholic Steatohepatitis (Nash)

Liver Disease

Treatment

Placebo ( FE)

IMM-H014

IMM-H014 ( FE)

Clinical Study ID

NCT06216041
2022-I-IMM-H014-01
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects can voluntarily participate in the clinical trial, sign informed consentbefore the trial, fully understand the trial content, process and possible adverseevents, and complete the study in accordance with the requirements of the trialprotocol;

  2. Subjects can use effective contraceptive methods, such as abstinence, condoms, IUDuse, and dual barrier method (such as condom plus diaphragm), within 6 months fromthe beginning of screening to the last trial drug administration;

  3. 18-45 years of age, male and female (including 18 and 45 years);

  4. Male weight ≥50kg, female weight ≥45kg; Body mass index (BMI) in the range of 18-28kg/m2 (including the cut-off value); 5)Vital signs and physical examination withnormal or abnormal has no clinical significance.

Exclusion

Exclusion Criteria:

  1. Clinical history of drug allergy or specific allergic diseases (asthma, urticaria),or known or suspected allergic history to experimental drugs and related excipients;

  2. Subjects who have used any prescription drugs, over-the-counter drugs, Chineseherbal medicines and health products within 2 weeks before screening;

  3. Clinical laboratory examination (blood routine, urine routine, blood biochemistry,coagulation function, virology examination, thyroid function), abdominal colorDoppler ultrasound (liver, gallbladder, spleen, pancreas, kidneys, adrenal gland),chest radiography and other abnormalities with clinical significance; Or otherclinically significant diseases (including but not limited to gastrointestinaltract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental orcardiovascular and cerebrovascular diseases) within 6 months before screening;

  4. Subjects who ate diets (including grapefruit or grapefruit products, pitaya, mango,etc.) that may affect drug metabolism within 7 days before screening, or hadstrenuous exercise, or the researchers thought that there were other dieters thataffected drug metabolism, absorption, distribution, metabolism and excretion;

  5. A family history of a first-degree relative (i.e., biological parent, sibling, orchild) with a risk factor for tip torsional ventricular tachycardia, or a familyhistory of short QT syndrome, long QT syndrome, sudden unexplained death in youth (less than/etc. 40 years old), or sudden infant death syndrome;

  6. Subjects who suffer from hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia,hypercalcemia or hypocalcemia which are abnormal and clinically significant by theinvestigator;

  7. Presence of clinically significant abnormalities in ECG or QTcF>450ms (correctedaccording to Frederica formula, the calculation method is QTCF = Qt/(RR 0.33));

  8. Creatinine clearance rate < 90mL/min (Creatinine clearance calculationCockcroft-Gault formula: CrCl = [(140 - age) by weight (kg)] / [0.814 x Scr (umol/L)] or CrCl = (140 - age) by weight (kg) / 72 x Scr (mg/dL), women need toaccording to the formula calculation results by 0.85);

  9. Suffering from chronic or active gastrointestinal diseases, such as esophagealdiseases, acute gastritis, gastric and duodenal ulcers, enteritis, activegastrointestinal bleeding, or gastrointestinal surgery, which investigators believeis still clinically relevant;

  10. Subjects who had undergone major surgery (excluding diagnostic surgery) in the sixmonths prior to screening, or who will undergo surgery during the study period, orwho had undergone surgery that the investigator determines will affect drugabsorption, distribution, metabolism, or excretion;

  11. Participants who had participated in other clinical trials within 3 months prior toscreening (participants can be enrolled if they withdraw from the study beforeadministration of the investigational drug, that is, they have not received thedrug);

  12. Blood donation or significant blood loss (> 450ml) within 3 months prior toscreening;

  13. Had a history of alcohol abuse (drinking an average of 14 units of alcohol per weekin the 3 months prior to screening (1 unit =360 mL beer or 45mL liquor with 40%alcohol or 150 ml wine), or could not abstinence during the test period, or had apositive alcohol breath test;

  14. Smoking more than 5 cigarettes per day in the 3 months before screening;

  15. Have a history of drug or drug abuse or urine drug abuse screening positive;

  16. Subjects who have special requirements for diet and cannot accept a unified diet;

  17. Have dysphagia;

  18. Female subjects are lactating or have positive serological pregnancy results.

  19. Acute illness or concomitant medication occurred between the screening stage and theadministration of the investigational drug;

  20. Ingested chocolate, any food or drink containing caffeine or rich in xanthineswithin 24 hours before first taking the experimental drug;

  21. Subjects who taken any alcohol-containing product or a positive alcohol breath testin the 24 hours prior to the use of the study drug;

  22. The investigator believes that the subjects are not suitable to participate in theclinical study for other reasons.

Study Design

Total Participants: 138
Treatment Group(s): 4
Primary Treatment: Placebo ( FE)
Phase: 1
Study Start date:
December 06, 2023
Estimated Completion Date:
August 01, 2025

Study Description

The study is a randomized, double-blind phase 1 trial including 3 parts: single ascending dose (SAD) part, multiple ascending dose (MAD) part and food effect (FE) part.

SAD and MAD parts adopt "sentinel method "which2 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). Subjects in SAD will receive 12.5,37.5,75, 125, 225, 275, 325mg (Cohort 1-4 and Cohort 6-8) once daily respectively. Subjects in MAD will receive 37.5, 75, 125, 175, 225mg (Cohort 9 - Cohort 13) once daily for 7days respectively.

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, and subjects will receive175mg(SAD Cohort 5) on fasting and postprandial states respectively. There will be a 7-day wash out period between treatment periods. To monitor AEs, record abnormalities (12-lead ECG, Vital signs, Physical examination, Clinical Laboratory), and detect the pharmacokinetics of IMM-H014.

Connect with a study center

  • The first Bethune hospital of Jilin University

    Changchun, Jilin
    China

    Active - Recruiting

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