Study of HM15912 in subjects with Short Bowel Syndrome-associated Intestinal Failure

Phase 1

Conditions: Short Bowel Syndrome-associated Intestinal Failure (SBS-IF)
MedDRA version: 20.1Level: PTClassification code 10049416Term: Short-bowel syndromeSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2021-000176-11-DK

Lead Sponsor: Hanmi Pharmaceutical Co., Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 18

Inclusion Criteria

1.Men or women, aged 18 years of age or older with SBS resulting in intestinal failure at the time of signing the informed consent form (ICF) (or country’s legal age of majority if the legal age is < 18 years).
2. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
3. Diagnosis of SBS with the latest intestinal resection being at least 6 months prior to Screening and considered stable regarding the PN/IV need. No restorative surgery planned in the study period
4. Stable PN/IV, defined as less than 25% change in volume and energy within 4 weeks prior to screening.
5. Willing to adhere to an individual 24-hour predefined drinking menu during 48-hours data collection periods
6. (Only for the subjects who have a remnant part of colon) Have no colon polyps or had colon polyps removed by colonoscopy (or sigmoidoscopy) within 6 months prior to Screening
7. Patients with jejunostomy or ileostomy and able to separate stool and urine during the 48-hour data collection period
8. Have body weight =30 kg and body mass index (BMI) >18 kg/m²
9. Have stable body weight during the last 6 months prior to Screening (±5% variations allowed)
10. If the subject is not naïve to treatment with GLP-2 analog, the subject may be enrolled if all the following criteria are met:
a. The duration of discontinuation of GLP-2 analog treatment should be at least 3 months prior to Screening
b. Willing to provide medical history and/or record to recognize any medically significant events during previous GLP-2 analog treatment
11. Sexually active female subjects of childbearing potential must use medically acceptable methods of birth control during the study and up to 60 days after the last dose of study drug (see Section 8.3.5 for a list of acceptable birth control methods).
12. Sexually active male subjects must use medically acceptable methods of birth control during the study and up to 60 days after the last dose of study drug (see Section 8.3.5 for a list of acceptable birth control methods).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

1. Any history of colon cancer
2. History of any other cancers (except margin-free resected cutaneous basal or squamous cell carcinoma or adequately treated in situ cervical cancer) unless disease-free for at least 5 years
3. History of alcohol or drug abuse (within 1 year of Screening)
4. Current participation in another study of an investigational agent or investigational device (catheter lock trials are allowed) within 4 weeks prior to the signing the ICF
5. Have a body weight >100 kg
6. Have clinically significant abnormal ECG findings (e.g., QTcF > 450 msec for males, QTcF > 470 msec for females, left bundle branch block) that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results
7. Have repeated (2 or more consecutive measurements separated by at least 15 minutes) systolic blood pressure (BP) measurements >140 mm Hg
8. Have a hospital admission within 1 month prior to Screening visit
9. Females who are pregnant, breastfeeding, or expect to become pregnant within the projected duration of the study, starting with the Screening visit through 60 days after the final dose of study drug
10. Males who plan to father children within the projected duration of the study, starting with the Screening visit through 60 days after the final dose of study drug
11. Have any of the following conditions:
a. Radiation enteritis
b. Scleroderma
c. Celiac disease (based on the review of medical history; subjects with normalized antibodies and histology can be considered for enrollment)
d. Refractory/tropical sprue
e. Pseudo-obstruction
f. Cystic fibrosis
g. Pre-malignant/malignant change in colonoscopy biopsy or polypectomy
h. Surgery scheduled during the study period
i. Positive Human immunodeficiency virus (HIV) test
j. Active (chronic or acute) hepatitis B or C test
k. Positive syphilis test
l. Significant, active, uncontrolled, untreated systemic diseases
12. Cannot maintain clinical remission of inflammatory bowel disease (IBD) prior to 3 months of Screening demonstrated by clinical assessment
Note: Ulcerative Colitis (UC) Mayo Score < 2, Crohn’s Disease (CD): Crohn’s Disease Active Index (CDAI) <150
13. Have more than 4 hospitalizations related to PN/IV volume adjustments within 12 months of Screening
14. Have cardiac disease defined as decompensated heart failure (New York Heart Association Class III-IV), unstable angina pectoris, and/or myocardial infarction within the last 6 months prior to Screening
15. Have estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73 m² by Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) 2021 or require hemodialysis.
16. Clinically significant laboratory abnormalities at the time of Screening, defined as having:
a. Platelet count < 100 × 10³/µL
b. White blood cell count < 3.5 × 10³/µL
c. Neutrophil count < 1.5 × 10³/µL
d. Hemoglobin level < 8 g/dL
17. Persistent hepatic impairment defined by two of the following laboratory tests meeting the criteria below. Repeat tests done within 2 weeks apart must confirm the results.
a. Total bilirubin = 2 × the upper limit of normal (ULN), or
b. Aspartate aminotransferase (AST) = 5 × ULN, or
c. Alanine aminotransferase (ALT) = 5× ULN
18. Have any use of GLP-1, dipeptidyl peptidase 4 (DPP-4) inhibitor, growth hormone, glutamine, or analogs thereof within 3 months prior to Screening.
19. Subject deemed by the Investigator to be inappropriate for participation in the study (e.g., any condition or ci

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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