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

Launched by CHANGCHUN INTELLICROWN PHARMACEUTICAL CO. LTD · Jan 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called IMM-H014 to see how safe it is and how well it works in people with a liver condition known as nonalcoholic steatohepatitis (NASH). The trial will involve healthy volunteers who will take either IMM-H014 or a placebo (a dummy pill) in different ways—sometimes on an empty stomach and sometimes after eating a high-fat meal. The study is divided into three parts to assess how the body handles the medication and to check for any side effects.

To participate in this trial, volunteers need to be between 18 and 45 years old, and meet certain health criteria, including being of a healthy weight. They should not have any significant health issues or allergies that could affect their participation. Participants can expect to visit the study site for assessments and to take the medication under careful supervision. It's important to note that those involved will need to follow specific dietary guidelines and avoid certain substances before and during the study. This helps ensure the safety and accuracy of the trial results.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects can voluntarily participate in the clinical trial, sign informed consent before the trial, fully understand the trial content, process and possible adverse events, and complete the study in accordance with the requirements of the trial protocol;
• • 2. Subjects can use effective contraceptive methods, such as abstinence, condoms, IUD use, and dual barrier method (such as condom plus diaphragm), within 6 months from the 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 18-28 kg/m2 (including the cut-off value); 5）Vital signs and physical examination with normal or abnormal has no clinical significance.
• 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, Chinese herbal 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 color Doppler ultrasound (liver, gallbladder, spleen, pancreas, kidneys, adrenal gland), chest radiography and other abnormalities with clinical significance; Or other clinically significant diseases (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular 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 had strenuous exercise, or the researchers thought that there were other dieters that affected drug metabolism, absorption, distribution, metabolism and excretion;
• • 5. A family history of a first-degree relative (i.e., biological parent, sibling, or child) with a risk factor for tip torsional ventricular tachycardia, or a family history 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 the investigator;
• • 7. Presence of clinically significant abnormalities in ECG or QTcF\>450ms (corrected according to Frederica formula, the calculation method is QTCF = Qt/(RR 0.33));
• • 8. Creatinine clearance rate \< 90mL/min (Creatinine clearance calculation Cockcroft-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 to according to the formula calculation results by 0.85);
• • 9. Suffering from chronic or active gastrointestinal diseases, such as esophageal diseases, acute gastritis, gastric and duodenal ulcers, enteritis, active gastrointestinal bleeding, or gastrointestinal surgery, which investigators believe is still clinically relevant;
• • 10. Subjects who had undergone major surgery (excluding diagnostic surgery) in the six months prior to screening, or who will undergo surgery during the study period, or who had undergone surgery that the investigator determines will affect drug absorption, distribution, metabolism, or excretion;
• • 11. Participants who had participated in other clinical trials within 3 months prior to screening (participants can be enrolled if they withdraw from the study before administration of the investigational drug, that is, they have not received the drug);
• • 12. Blood donation or significant blood loss (\> 450ml) within 3 months prior to screening;
• • 13. Had a history of alcohol abuse (drinking an average of 14 units of alcohol per week in 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 a positive 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 the administration of the investigational drug;
• • 20. Ingested chocolate, any food or drink containing caffeine or rich in xanthines within 24 hours before first taking the experimental drug;
• • 21. Subjects who taken any alcohol-containing product or a positive alcohol breath test in the 24 hours prior to the use of the study drug;
• • 22. The investigator believes that the subjects are not suitable to participate in the clinical study for other reasons.