Efficacy, Safety, and Tolerability of 4-MUST, 128 mg Tablets in Chronic Cholecystitis and Biliary Dyskinesia

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of 4-MUST, 128 mg Tablets in Patients With Chronic Cholecystitis and Biliary Tract Dyskinesia

The aim of the study is to evaluate the efficacy, safety, and tolerability of 4-MUST, 128 mg tablets compared to placebo in patients with chronic cholecystitis and biliary dyskinesia.

Study Overview

• Status: Recruiting
• Conditions: Biliary Dyskinesia; Chronic Cholecystitis
• Intervention / Treatment: Drug: Placebo; Drug: 4-MUST

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russia
  • Moscow, Russia, 119571
    • Recruiting
    • Unimed-C Jsc
    • Contact: Olga Orlova, MD; Phone Number: +7 (919) 994-90-14; Email: orlelik@mail.ru
  • Moscow, Russia, 117556
    • Recruiting
    • State Budgetary Institution of Healthcare of Moscow "City Polyclinic No. 2 of the Moscow Department of Healthcare"
    • Contact: Margarita Dorofeeva, MD, PhD; Phone Number: +7 (916) 128-99-78; Email: margaritadorofeeva@yandex.ru
  • Moscow, Russia
    • Recruiting
    • The State Budgetary Healthcare Institution of the Moscow Region "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky"
    • Contact: Olga Kostyukevich, MD, PhD; Phone Number: +7 (916) 247-22-12; Email: kostyukevich@mail.ru
  • Novosibirsk, Russia
    • Recruiting
    • Limited Liability Company "ErSi Medical"
    • Contact: Anna Kosheleva, MD; Phone Number: +7-913-470-70-67; Email: annkosheleva86@gmail.com
  • Perm, Russia, 614990
    • Recruiting
    • Federal State Budgetary Educational Institution of Higher Education "Academician E.A. Wagner Perm State Medical University" of the Ministry of Healthcare of the Russian Federation
    • Contact: Natalia Osokina, MD, PhD; Phone Number: +7 (950) 460-96-74; Email: kiselevanatalya8@mail.ru
  • Saint Petersburg, Russia, 194358
    • Recruiting
    • St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"
    • Contact: Diana Alpenidze, MD,PhD; Phone Number: +7 (911) 760-51-15; Email: d.alpenidze@mail.ru
  • Saint Petersburg, Russia, 196143
    • Recruiting
    • Limited Liability Company "Research Center Eco-Safety"
    • Contact: Vasiliy Vasilyuk, MD, PhD; Phone Number: +7 (901) 304 4248; Email: vasilyuk_vb@ecosafety.ru
  • Saint Petersburg, Russia, 196158
    • Recruiting
    • Limited Liability Company "Clinic Zvezdnaya"
    • Contact: Dmitry Shkarbul, MD; Phone Number: +7 (911) 218-10-55; Email: director@starsclinic.ru
  • Saratov, Russia, 410071
    • Recruiting
    • State Healthcare Institution "Saratov City Clinical Hospital No. 5"
    • Contact: Evgenii Orlikov, MD; Phone Number: +7 (906) 307-29-00; Email: eorlikov@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Males and females aged 18-70 years.
2. Diagnosed with chronic cholecystitis (K81.1) and/or dyskinesia of the cystic duct or gallbladder (K82.8) prior to enrollment; diagnosis supported by clinical history of exacerbations and remissions and/or imaging/laboratory findings.
3. Upper abdominal pain or discomfort attributable to gallbladder or biliary tract dysfunction (per investigator assessment), accompanied by ≥1 of the following: heartburn, belching, nausea, abdominal bloating, borborygmi (stomach rumbling), flatulence, constipation, or diarrhea.
4. Maximum severity of pain/discomfort in the upper abdomen over the past week is 40 mm or more on the VAS (Visual Analog Scale).
5. Severity of gastrointestinal symptoms according to the GSRS (Gastrointestinal Symptom Rating Scale) questionnaire is at least 30 points.
6. The total bilirubin level does not exceed 2 times the upper limit of normal (no more than 42 μmol/L).
7. Women who are either sexually abstinent or using effective contraception methods (e.g. intrauterine devices, contraceptive patches, long-acting injectable contraceptives, or double barrier methods) for at least 8 weeks before and 3 weeks after the end of the study, with a confirmed negative pregnancy test, as well as women with documented infertility or non-childbearing status (e.g. hysterectomy, tubal ligation, infertility or menopause for more than 1 year) or men using barrier contraceptives throughout the study and for 3 weeks after its completion, or men unable to conceive (documented conditions: vasectomy, infertility).
8. Signed and dated informed consent from.

Non-inclusion Criteria:

1. Gastric or duodenal ulcer, erosive gastroesophageal reflux disease (GERD), or other inflammatory/erosive gastrointestinal diseases in the acute stage, unless stable remission for ≥ 1 year since the last exacerbation.
2. Indication for surgical or endoscopic intervention due to exacerbation of chronic cholecystitis or complications of biliary tract dyskinesia.
3. Toxic megacolon.
4. Paralytic ileus.
5. Gilbert's syndrome.
6. Choledocholithiasis (or a high risk of its development, as determined by the investigator);
7. Impaired bile outflow due to adhesions in the abdominal cavity.Abdominal adhesion disease.
8. Irritable bowel syndrome, non-specific ulcerative colitis, Crohn's disease.
9. Gastrointestinal malignancy (including history of) or suspected gastrointestinal malignancy (e.g., blood in stool, unexplained weight loss, fever, anemia).
10. Any other oncological diseases known at the time of screening, or suspicion thereof.
11. History of gastrointestinal surgery, including cholecystectomy or endoscopic sphincterotomy (appendectomy excluded).
12. Use of prohibited therapy medications within 3 days prior to randomization.
13. History of mental illnesses.
14. Chronic heart failure IIb-III stages and/or III-IV functional classes according to NYHA, angina pectoris III-IV functional classes.
15. Chronic kidney disease stage IIIa-V (according to NKF/KDOQI, 2006).
16. History of or current hepatic impairment; or liver test abnormalities: AST, ALT, ALP, or GGT >3 above the upper limit of normal (ULN); total bilirubin >2 ULN or clinical jaundice.
17. HIV, syphilis, viral hepatitis B or C, including in history.
18. Lactose intolerance, lactase deficiency, and glucose-galactose malabsorption syndrome.
19. Liver cirrhosis.
20. Hypersensitivity to the active ingridient or any of the excipients of the drug 4-MUST.
21. Severe, decompensated, or unstable somatic conditions that are life-threatening, worsen prognosis, or preclude safe study participation.
22. Diabetes mellitus in a state of subcompensation and decompensation.
23. Systemic connective tissue diseases.
24. Autoimmune diseases.
25. Indication for hemodialysis procedures.
26. Epilepsy or seizures of unclear etiology, including in history.
27. Alcoholism, substance abuse or drug addiction, including in history.
28. Uncorrected electrolyte disturbances.
29. QTcF interval on a 12-lead electrocardiogram (ECG) ≥430 ms in men and ≥450 ms in women.
30. Episodes of constipation during the last 3 months that required the prescription of drug therapy.
31. History of surgery within 6 month prior to screening.
32. Women during pregnancy or lactation; women planning to become pregnant within the next 6 months.
33. Patients who require prohibited concomitant therapy within this study framework.
34. Participation in another clinical trial within the last 3 months prior to the screening visit date.
35. Unwillingness or inability to comply with study procedures and protocol requirements..
36. Other conditions that, in the investigator's judgement, may preclude the patient's participation in the study.

Exclusion Criteria:

1. Incorrect enrollment of a patient in the study (failure to meet inclusion/exclusion criteria at the time of randomization).
2. Lack of Efficacy. Study treatment will be discontinued if no clinical improvement is observed by Visit 3 (Day 15 ± 1), defined as persistence or worsening of upper abdominal pain/discomfort (assessed by Visual Analog Scale [VAS]) compared to baseline. Upon discontinuation, alternative therapy will be initiated at the investigator's discretion.
3. Patient non-compliance (a compliant patient is defined as one who has taken at least 202 and no more than 303 tablets).
4. Requirement for prohibited concomitant therapy.
5. Use of Duspatalin® (INN: mebeverine) for more than 3 consecutive days or for more than 5 days in total throughout the study.
6. If the investigator judges that comtinued participation in the study would harm the patient.
7. Pregnancy or the need for breastfeeding.
8. Major protocol deviation by the subject with respect to procedures outlined in the Informed Consent Form (ICF).
9. Withdrawal of informed consent by the subject (decision to discontinue study participation).
10. Lost to follow-up: Inability to contact the subject after ≥3 documented attempts via mobile phone, landline (if applicable), and designated emergency contact.
11. Emergence during the study of any diseases or conditions that worsen the patient's prognosis, making it impossible for the patient to continue participating in this clinical trial.
12. Any other reasons, including administrative issues, that in the investigator's judgement may interfere with subject's ability to comlete the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4-MUST; 4-MUST: 384 mg (3 tablets), orally three times a day (TID), 30 min before meals. Total daily dose - 1152 mg.	Drug: 4-MUST; 128 mg of trimebutine 4-methylumbelliferyl sulfate tablet.; Other Names: trimebutine 4-methylumbelliferyl sulfate
Placebo Comparator: Placebo; Placebo: 3 tablets, orally three times a day (TID), 30 min before meals.	Drug: Placebo; Placebo tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean reduction in the severity of pain/discomfort in the upper abdomen on the VAS by day 29 compared to baseline	Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"	Day 29 ± 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability: vital signs - systolic blood pressure (SBP)	SBP, mmHg	Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
Safety and Tolerability: vital signs - diastolic blood pressure (DBP)	DBP, mmHg	Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
Safety and Tolerability: vital signs - respiratory rate (RR)	RR, breaths per minute	Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
Safety and Tolerability: vital signs - heart rate (HR)	HR, beats per minute	Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
Safety and Tolerability: vital signs - body temperature	Body temperature, Celsius scale	Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
Physical examination results: cardiovascular system	An assessment of the condition of the cardiovascular system on physical examination (normal condition or list of abnormal conditions, if any)	Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
Physical examination results: digestive tract	An assessment of the condition of the digestive tract on physical examination (normal condition or list of abnormal conditions, if any)	Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
Physical examination results: endocrine system	An assessment of the condition of the endocrine system on physical examination (normal condition or list of abnormal conditions, if any)	Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
Physical examination results: musculoskeletal system	An assessment of the condition of the musculoskeletal system on physical examination (normal condition or list of abnormal conditions, if any)	Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
Physical examination results: nervous system	An assessment of the condition of the nervous system on physical examination (normal condition or list of abnormal conditions, if any)	Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
Physical examination results: sensory systems	An assessment of the condition of the sensory systems on physical examination (normal condition or list of abnormal conditions, if any)	Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
Physical examination results: skin/visible mucous membranes	An assessment of the condition of the skin/visible mucous membranes on physical examination (normal condition or list of abnormal conditions, if any)	Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: clinical blood test - hemoglobin	Hemoglobin (g/L)	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: clinical blood test - hematocrit	Hematocrit (%)	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: clinical blood test - red blood cell count	Red blood cell count (cells/L)	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: clinical blood test - platelet count	Platelet count (cells/L)	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: clinical blood test - leukocyte count	Leukocyte count (cells/L)	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: clinical blood test - erythrocyte sedimentation rate	Erythrocyte sedimentation rate (mm/h)	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: clinical blood test - myelocytes	Leukocyte formula (myelocytes, %)	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: clinical blood test - band neutrophils	Leukocyte formula (band neutrophils, %)	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: clinical blood test - segmented neutrophils	Leukocyte formula (segmented neutrophils, %)	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: clinical blood test - eosinophils	Leukocyte formula (eosinophils, %)	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: clinical blood test - basophils	Leukocyte formula (basophils, %)	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: clinical blood test - monocytes	Leukocyte formula (monocytes, %)	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: clinical blood test - lymphocytes	Leukocyte formula (lymphocytes, %)	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: blood chemistry - glucose	Glucose concentration (mmol/L)	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: blood chemistry - cholesterol	Total cholesterol concentration (mmol/L)	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: blood chemistry - protein	Total protein concentration (g/L)	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: blood chemistry - bilirubin	Total bilirubin concentration (micromol/L)	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: blood chemistry - creatinine	Creatinine concentration (micromol/L)	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: blood chemistry - alkaline phosphatase	Alkaline phosphatase activity (U/L)	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: blood chemistry - alanine transaminase	Alanine transaminase activity (U/L)	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: blood chemistry - aspartate transaminase	Aspartate transaminase activity (U/L)	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: blood chemistry - gamma-GTP	Gamma-glutaryl transpeptidase activity (U/L)	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: urinalysis - specific gravity	Specific gravity of the urine	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: urinalysis - pH	pH of the urine	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: urinalysis - protein	Protein concentration (g/L)	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: urinalysis - glucose	Glucose concentration (mmol/L)	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: urinalysis - red blood cells	Red blood cell content (number in sight)	Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: urinalysis - white blood cells	White blood cell content (number in sight)	Screening, day 15 ± 1, day 29 ± 1
Mean reduction in the severity of pain/discomfort in the upper abdomen according to VAS by days 2-28 from the start of therapy	Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"	Day 2 - Day 28
Frequency of response to therapy (proportion of patients in the group with a reduction in the severity of pain/discomfort in the upper abdomen according to VAS by 30% or more) by days 8, 15, 22, and 29 following treatment initiation.	Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"	Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
Frequency of response to therapy (proportion of patients in the group with a reduction in the severity of pain/discomfort in the upper abdomen according to VAS by 50% or more) by days 8, 15, 22, and 29 following treatment initiation.	Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"	Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
Time to therapeutic response (reduction in the severity of pain/discomfort in the upper abdomen according to VAS by 30% or more)	Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"	Day 29 ± 1
Time to therapeutic response (reduction in the severity of pain/discomfort in the upper abdomen according to VAS by 50% or more)	Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"	Day 29 ± 1
Frequency of clinical recovery (proportion of patients in the group with a reduction in the severity of pain/discomfort in the upper abdomen according to VAS to 10 mm or less) by days 8, 15, 22, and 29 following treatment initiation.	Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"	Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
Time to clinical recovery (reduction in the severity of pain/discomfort in the upper abdomen according to VAS to 10 mm or less)	Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"	Day 29 ± 1
Change in the total score of gastroenterological symptom severity according to the GSRS questionnaire by days 8, 15, 22, and 29 following treatment initiation.	The Gastrointestinal Symptom Rating Scale (GSRS) is a self-administered questionnaire designed to assess gastrointestinal symptoms and their severity. It consists of 15 items categorized into five domains: Abdominal pain (including stomach pain and nausea), Reflux (heartburn and acid reflux), Indigestion (bloating, burping, and flatulence), Constipation (hard stools and incomplete evacuation), Diarrhea (loose stools and urgency). Respondents rate their symptoms on a 7-point Likert scale, where 1 indicates no discomfort and 7 indicates very severe discomfort.	Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
Change in dyspeptic symptom severity, as assessed by the GSRS, expressed as score changes from baseline in the Abdominal Pain, Reflux, Indigestion, Diarrhea, and Constipation syndrome subscales at Days 8, 15, 22, and 29 following treatment initiation.	The Gastrointestinal Symptom Rating Scale (GSRS) is a self-administered questionnaire designed to assess gastrointestinal symptoms and their severity. It consists of 15 items categorized into five domains: Abdominal pain (including stomach pain and nausea), Reflux (heartburn and acid reflux), Indigestion (bloating, burping, and flatulence), Constipation (hard stools and incomplete evacuation), Diarrhea (loose stools and urgency). Respondents rate their symptoms on a 7-point Likert scale, where 1 indicates no discomfort and 7 indicates very severe discomfort.	Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
Change in the severity of individual symptoms of dyspeptic disorders according to the GSRS questionnaire in points by days 8, 15, 22, and 29 following treatment initiation.	The Gastrointestinal Symptom Rating Scale (GSRS) is a self-administered questionnaire designed to assess gastrointestinal symptoms and their severity. It consists of 15 items categorized into five domains: Abdominal pain (including stomach pain and nausea), Reflux (heartburn and acid reflux), Indigestion (bloating, burping, and flatulence), Constipation (hard stools and incomplete evacuation), Diarrhea (loose stools and urgency). Respondents rate their symptoms on a 7-point Likert scale, where 1 indicates no discomfort and 7 indicates very severe discomfort.	Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
Change in quality of life according to the total score on the SF-36 questionnaire by day 29 from treatment initiation.	SF-36 (Short Form 36 Health Survey) is a self-reported questionnaire. It consists of 36 items that cover eight health domains: Physical functioning, Role limitations due to physical health, Role limitations due to emotional problems, Bodily pain, General health perceptions, Vitality (energy and fatigue), Social functioning, Mental health. SF-36 produces a profile of scores for each domain, which can be summarized into two main components: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Scores range from 0 to 100, where lower scores indicate greater disability and higher scores indicate better health.	Day 29 ± 1
Change in the total score on the PAGI-SYM questionnaire by days 15 and 29 from treatment initiation.	PAGI-SYM (Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index) is a patient-reported questionnaire designed to assess the severity of symptoms in upper gastrointestinal disorders (GERD, dyspepsia, and gastroparesis). It consists of 20 items grouped into six subscales: Heartburn/Regurgitation, Fullness/Early Satiety, Nausea/Vomiting, Bloating, Upper Abdominal Pain, and Lower Abdominal Pain. Each symptom is rated on a 6-point Likert scale from 0 (none) to 5 (very severe). The questionnaire provides a profile of scores for each subscale, as well as a total score. Higher scores indicate greater symptom severity.	Day 15 ± 1, and 29 ± 1
change in the total score on the Visceral Sensitivity Index questionnaire by days 15 and 29 from the start of therapy	VSI (Visceral Sensitivity Index) is a patient-reported questionnaire measuring gastrointestinal-specific anxiety (cognitive, affective, and behavioral responses to GI sensations). It consists of 15 items rated on a 6-point scale, producing a total score from 0 to 75. Higher scores indicate greater GI-specific anxiety. Originally validated in IBS patients, it is now used across various GI disorders.	Day 15 ± 1, and 29 ± 1
Change in the total score on the Emotional Distress - Depression - Short Form 4a questionnaire by days 8, 15, 22, and 29 from the start of therapy	Emotional Distress - Depression - Short Form 4a (PROMIS Depression SF 4a) is a patient-reported questionnaire assessing depression symptoms over the past 7 days. It consists of 4 items rated on a 5-point scale. Raw scores (4-20) are converted to a standardized T-score (mean=50, SD=10). Higher scores indicate greater depression severity.	Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
Safety and Tolerability: adverse event (AE) rate	Frequency of adverse events (AEs) or serious AEs (SAEs)	From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
Safety and Tolerability: adverse event (AE) number	Number of adverse events (AEs) or serious AEs (SAEs)	From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
Safety and Tolerability: AEs associated with the study drug	Number and frequency of AEs associated with the study drug	From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
Safety and Tolerability: SAEs associated with the study drug	Number and frequency of SAEs associated with the study drug	From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
Safety and Tolerability: treatment discontinuation	Percentage of patients who discontinued treatment due to the occurrence of AEs/SAEs	From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
Physical examination results: respiratory system	An assessment of the condition of the respiratory system on physical examination (normal condition or list of abnormal conditions, if any)	Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: blood chemistry - CRP	C-reactive protein, CRP (mg/L)	Screening, day 15 ± 1, day 29 ± 1
Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate	12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: heart rate (beats per minute)	Screening, day 1, day 29 ± 1
Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval	12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: PQ interval (is the period, measured in milliseconds, that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex)	Screening, day 1, day 29 ± 1
Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex	12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: QRS complex (the QRS complex is the combination of three of the graphical deflections seen on a typical electrocardiogram)	Screening, day 1, day 29 ± 1
Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval	12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: corrected QT interval (distance from the beginning of the QRS complex to the end of the T wave) (Frederica correction)	Screening, day 1, day 29 ± 1

Collaborators and Investigators

• Sponsor: Valenta Pharm JSC

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Common Bile Duct Diseases; Biliary Dyskinesia
• Other Study ID Numbers: GIB-03-04-2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No