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Tests treatment safety and results for Nonalcoholic Steatohepatitis (NASH)
Official title To Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of IMM-H014 in Healthy Subjects
ClinicalTrials.gov ID: NCT06216041
What this study is testing
What is IMM-H014?
IMM-H014 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for nonalcoholic steatohepatitis (nash).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- people can voluntarily participate in the clinical trial, sign informed consent before the trial, fully understand the trial content, process and...
- people can use effective contraceptive methods, such as abstinence, condoms, IUD use, and dual barrier method (such as condom plus diaphragm), within...
- 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...
You likely can't join if
- Clinical history of drug allergy or specific allergic diseases (asthma, urticaria), or known or suspected allergic history to experimental drugs and...
- people 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)...
- people who ate diets (including grapefruit or grapefruit products, pitaya, mango, etc.) that may affect drug metabolism within 7 days before...
- A family history of a first-degree relative (i.e., biological parent, sibling, or child) with a risk factor for tip torsional ventricular...
- people who suffer from hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia which are abnormal and clinically...
See the full eligibility criteria
- people 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...
- people 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...
- 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.
- Clinical history of drug allergy or specific allergic diseases (asthma, urticaria), or known or suspected allergic history to experimental drugs and related excipients;
- people 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...
- people 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...
- 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...
- people who suffer from hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia which are abnormal and clinically significant by the investigator;
- 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)...
- 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...
- people 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...
- 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...
- 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...
- 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;
- people who have special requirements for diet and cannot accept a unified diet;
- Have dysphagia;
- Female people 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;
- people 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 people are not suitable to participate in the clinical study for other reasons.
The study team makes the final eligibility decision.
Where it's taking place
- Changchun, Jilin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changchun, Jilin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.