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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

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

To Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of IMM-H014 in Healthy Subjects (NCT06216041) is a Phase 1 interventional studying Nonalcoholic Steatohepatitis (NASH), sponsored by Changchun Intellicrown Pharmaceutical Co. Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Nonalcoholic Steatohepatitis (NASH), a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 138 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Nonalcoholic Steatohepatitis (NASH) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Subjects can voluntarily participate in the clinical trial, sign willing to sign a consent form 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. Who Should NOT Join This Trial: 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; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

IMM-H014

SAD and MAD adopt "sentinel method "which 2 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).

DRUG

Placebo

SAD and MAD adopt "sentinel method "which 2 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).

DRUG

IMM-H014 ( FE)

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.

DRUG

Placebo ( FE)

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The first Bethune hospital of Jilin University
Changchun, Jilin, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06216041), the sponsor (Changchun Intellicrown Pharmaceutical Co. Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06216041 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06216041?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06216041?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06216041. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06216041. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.