Evaluating the safety and effects of IMM-H014 in healthy individuals

A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of IMM-H014 Sand the Effects of Food on Pharmacokinetics in Healthy Subjects

This study is testing a new drug called IMM-H014 in healthy people to see if it's safe and how it behaves in the body.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 138 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Changchun Intellicrown Pharmaceutical Co. LTD (Industry-sponsored)
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT06216041 on ClinicalTrials.gov

What this trial studies

This clinical trial assesses the safety, tolerability, and pharmacokinetics of the drug IMM-H014 in healthy subjects through a randomized, double-blind design. The study consists of three parts: single ascending doses, multiple ascending doses, and food effect evaluations. Participants will receive either IMM-H014 or a placebo, with doses varying across different cohorts. The trial aims to monitor adverse events and pharmacokinetic profiles under both fasting and postprandial conditions.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18-45 with a BMI between 18-28 kg/m2.

Not a fit: Patients with a history of drug allergies or specific allergic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a better understanding of IMM-H014's safety and effectiveness for treating conditions like Nonalcoholic Steatohepatitis (NASH).

How similar studies have performed: Other studies evaluating similar pharmacokinetic profiles and safety assessments have shown promise, but this specific approach may be novel.

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.

Where this trial is running

Changchun, Jilin

• The first Bethune hospital of Jilin University — Changchun, Jilin, China (Recruiting)

Study contacts

• Principal investigator: Hong Zhang — The First Hospital of Jilin University
• Study coordinator: Shiqi Bai

Conditions Nonalcoholic Steatohepatitis; Adverse Event