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Nonalcoholic Steatohepatitis (NASH)Phase 1NCT06216041

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

A Phase 1 study testing IMM-H014 and IMM-H014 ( FE) in people with Nonalcoholic Steatohepatitis (NASH), run by Changchun Intellicrown Pharmaceutical Co. LTD at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Nonalcoholic Steatohepatitis (NASH)
What is being tested?
IMM-H014 and IMM-H014 ( FE)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
138 participants
Where
1 siteChina
Study dates
6 Dec 2023to 1 Aug 2025
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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;
  • 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;
  • 18-45 years of age, male and female (including 18 and 45 years);
  • 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 cannot join

  • Clinical history of drug allergy or specific allergic diseases (asthma, urticaria), or known or suspected allergic history to experimental drugs and related excipients;
  • Subjects who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines and health products within 2 weeks before screening;
  • 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;
  • 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;
  • 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;
  • Subjects who suffer from hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia which are abnormal and clinically significant by the investigator;
Show all 22Show fewer
  • Presence of clinically significant abnormalities in ECG or QTcF>450ms (corrected according to Frederica formula, the calculation method is QTCF = Qt/(RR 0.33));
  • 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);
  • 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;
  • 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;
  • 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);
  • Blood donation or significant blood loss (> 450ml) within 3 months prior to screening;
  • 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;
  • Smoking more than 5 cigarettes per day in the 3 months before screening;
  • Have a history of drug or drug abuse or urine drug abuse screening positive;
  • Subjects who have special requirements for diet and cannot accept a unified diet;
  • Have dysphagia;
  • Female subjects are lactating or have positive serological pregnancy results.
  • Acute illness or concomitant medication occurred between the screening stage and the administration of the investigational drug;
  • Ingested chocolate, any food or drink containing caffeine or rich in xanthines within 24 hours before first taking the experimental drug;
  • 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;
  • The investigator believes that the subjects are not suitable to participate in the clinical study for other reasons.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shiqi Bai contact

18943642700

baishiqi@intelli-crown.com

China1 site, 1 recruiting

  • The first Bethune hospital of Jilin University

    Changchun, Jilin

    hong Zhang

    Recruiting

Other trials in China

About this study

Official title: 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 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.

Read the detailed 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.

Being tested
IMM-H014, Placebo, IMM-H014 ( FE), Placebo ( FE)
Keywords
Adverse Event
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMM-H014Drug

    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).

  • PlaceboDrug

    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).

  • IMM-H014 ( FE)Drug

    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.

  • Placebo ( FE)Drug

    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.

Study groups in NCT06216041
Study groupRoleWhat they receive
IMM-H014 /Placebo(single dose) 12.5 mg (Cohort 1)ExperimentalIMM-H014 /Placebo tablets administered orally once daily under fasted condition.
Receives: Drug: IMM-H014; Drug: Placebo
IMM-H014 /Placebo((single dose) 37.5 mg Cohort(Cohort 2)ExperimentalIMM-H014 /Placebo tablets administered orally once daily under fasted condition.
Receives: Drug: IMM-H014; Drug: Placebo
IMM-H014 /Placebo(single dose) 75 mg (Cohort 3)ExperimentalIMM-H014 /Placebo tablets administered orally once daily under fasted condition.
Receives: Drug: IMM-H014; Drug: Placebo
IMM-H014 /Placebo(single dose) 125 mg(Cohort 4)ExperimentalIMM-H014 /Placebo tablets administered orally once daily under fasted condition.
Receives: Drug: IMM-H014; Drug: Placebo
IMM-H014 /Placebo(single dose and food effect) 175mg (Cohort 5)ExperimentalPeriod 1 (Day1 to Day4): Group A and Group B receive IMM-H014 /Placebo under the fasting or fed condition ,respectively on Day1. Period 2 (Day 8 to Day11): Group A and Group B receive IMM-H014 /Placebo under the fed or fasting condition ,respectively on Day8.
Receives: Drug: IMM-H014 ( FE); Drug: Placebo ( FE)
IMM-H014 /Placebo(single dose) 225 mg (Cohort 6)ExperimentalIMM-H014 /Placebo tablets administered orally once daily under fasted condition.
Receives: Drug: IMM-H014; Drug: Placebo
IMM-H014 /Placebo(single dose) 275mg (Cohort 7)ExperimentalIMM-H014 /Placebo tablets administered orally once daily under fasted condition.
Receives: Drug: IMM-H014; Drug: Placebo
IMM-H014 /Placebo(single dose) 325 mg (Cohort 8)ExperimentalIMM-H014 /Placebo tablets administered orally once daily under fasted condition.
Receives: Drug: IMM-H014; Drug: Placebo
IMM-H014 /Placebo(multiple dose) tentative 37.5 mg(Cohort 9)ExperimentalIMM-H014 /Placebo tablets administered orally once daily under fasted condition for 7 Days(a total of 7 doses).
Receives: Drug: IMM-H014; Drug: Placebo
IMM-H014 /Placebo(multiple dose) tentative 75 mg(Cohort 10)ExperimentalIMM-H014 /Placebo tablets administered orally once daily under fasted condition for 7 Days(a total of 7 doses).
Receives: Drug: IMM-H014; Drug: Placebo
IMM-H014 /Placebo(multiple dose) tentative 125 mg(Cohort 11)ExperimentalIMM-H014 /Placebo tablets administered orally once daily under fasted condition for 7 Days(a total of 7 doses).
Receives: Drug: IMM-H014; Drug: Placebo
IMM-H014 /Placebo(multiple dose) tentative 175 mg(Cohort 12)ExperimentalIMM-H014 /Placebo tablets administered orally once daily under fasted condition for 7 Days(a total of 7 doses).
Receives: Drug: IMM-H014; Drug: Placebo
IMM-H014 /Placebo(multiple dose) tentative 225 mg(Cohort13)ExperimentalIMM-H014 /Placebo tablets administered orally once daily under fasted condition for 7 Days(a total of 7 doses).
Receives: Drug: IMM-H014; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events following oral doses (single, multiple and food effect)of IMM-H014 and placebo

    the adverse events are recorded according to the actual occurrence

    Measured: through study completion, up to 11, 17, 18 days for SAD, MAD, FE part

  2. Number of participants with abnormal laboratory tests results and abnormal physical exam findings

    The data of the clinical research center is collected and analyzed according to the time point of the test flow chart

    Measured: through study completion, up to 4, 10, 11 days for SAD, MAD, FE part

Secondary outcomes (11)

  1. PK parameters: AUClast（AUC0-t）

    AUClast is defined as the concentration of drug from time zero to the last quantifiable concentration.

    Measured: Up to 4, 10, 11 days for SAD, MAD, FE part

  2. PK parameters: AUCinf（AUC0-∞）

    AUCinf is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).

    Measured: Up to 4, 10, 11 days for SAD, MAD, FE part

  3. PK parameters: Cmax

    Cmax is defined as the maximum observed concentration of drug in plasma.

    Measured: Up to 4, 10, 11 days for SAD, MAD, FE part

  4. PK parameters: Tmax

    Tmax is defined as the time to maximum concentration.

    Measured: Up to 4, 10, 11 days for SAD, MAD, FE part

  5. PK parameters: t1/2

    t1/2z is defined as the time to decline half of the drug concentration in plasma.

    Measured: Up to 4, 10, 11 days for SAD, MAD, FE part

  6. PK parameters: CL/F

    λz is defined as the ratio between the elimination of compound per unit time and the total amount of compound.

    Measured: Up to 4, 10, 11 days for SAD, MAD, FE part

  7. PK parameters: λz

    λz is defined as the ratio between the elimination of compound per unit time and the total amount of compound.

    Measured: Up to 4, 10, 11 days for SAD, MAD, FE part

  8. Multiple-dose plasma PK parameter: Rac

    Rac (Accumulation Index) is defined as the ratio between AUC0-XX in Day XX and AUC0-XX in Day1

    Measured: Up to 10 days

  9. Multiple-dose plasma PK parameter: DF

    DF is defined as the percentage of fluctuation in steady state is 100 * (Cmax, ss - Cmin, ss)/Cavg, ss

    Measured: Up to 10 days

  10. Multiple-dose plasma PK parameter: Cmin

    Cmin is defined as the minimum observed concentration of drug in plasma at steady state.

    Measured: Up to 10 days

  11. Multiple-dose plasma PK parameter: Cmax

    Cmax is defined as the maximum observed concentration of drug in plasma at steady state.

    Measured: Up to 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2024
  2. Study start6 Dec 2023
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
138 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06216041
Sponsor's protocol ID
2022-I-IMM-H014-01
Status last verified
Apr 2025
First submitted
3 Jan 2024
Last updated
11 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMM-H014 and IMM-H014 ( FE) in people with Nonalcoholic Steatohepatitis (NASH), run by Changchun Intellicrown Pharmaceutical Co. LTD at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shiqi Bai (18943642700, baishiqi@intelli-crown.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events following oral doses (single, multiple and food effect)of IMM-H014 and placebo (time frame: through study completion, up to 11, 17, 18 days for SAD, MAD, FE part). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06216041.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.

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