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-PL

Lead Sponsor: Hanmi Pharm. Co., Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 7

Inclusion Criteria

1. Men or women, aged 18 years of age or older with intestinal failure resulting in SBS 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 defined as remaining small bowel in continuity of estimated <200 cm (equal to 79
inches) and 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. Require PN/IV at least 3 days per week for at least 12 months
5. Are willing to adhere to an individual predefined drinking menu during 48-hours recording periods
6. Have no colon polyps or had colon polyps removed by colonoscopy within 6 months prior to
Screening
7. (Only for the subjects who have a remnant part of colon). Not connected to the passage of foods and thereby dormant, can have an
abdominal ultrasound, computerized tomography (CT) scan, or magnetic resonance imaging (MRI)
instead of colonoscopy (if standard of care at site), at the discretion of the Investigator.
Note: If the subject has undergone an upper GI with small bowel follow-through or an abdominal
ultrasound within 6 months before Screening, those test results will be acceptable for the screening
assessments. If the subject has not had these procedures within the 6 months before Screening, then
the procedures will be performed any time after providing informed consent with the results available
and reviewed before Day -1.
8. Have a stoma and able to separate stool and urine during the 48-hour measuring intervals
9. 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
10. Have body weight =30 kg and body mass index (BMI) >18 kg/m2
11. Have at least 12 weeks of clinical remission of Crohn's disease (CD) prior to dosing as demonstrated
by clinical assessment (e.g. Crohn's Disease Activity Index [CDAI], Harvey-Bradshaw Index [HBI])
12. Have stable body weight during the last 3 months prior to Screening (±5% variations allowed)
13. Sexually active female subjects of child-bearing 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)
14. 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 7
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 no 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. Active inflammatory bowel disease (IBD) [see inclusion criterion 11],
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. Positive hepatitis B or C test,
k. Positive syphilis test,
l. Unstable immunological disorders such as rheumatoid arthritis or ulcerous colitis (If the
Investigator would like to enroll a subject with immunological disorders, he/she should
discuss this with the Sponsor and Medical Monitor before enrollment),
m. Significant, active, uncontrolled, untreated systemic diseases
12. Have unstable Crohn’s disease (CD) expected it to worsen over the course of the study and that
required initiation of treatment with biological therapy within 6 months prior to Screening
Note: Subjects treated with stable (unchanged dosage) of immunosuppressant therapy and biological
therapy are eligible for enrollment in the study.
13. Have IBD that required chronic systemic immunosuppressant therapy that had been introduced or
changed during the 3 months prior to Screening
14. Have unstable biological therapy (e.g., anti-tumor necrosis factor (TNF)-a, natalizumab, etc.) within 6
months prior to Screening, including significant changes in doses or switch of drug
15. Have unstable absorption due to cystic fibrosis or known deoxyribonucleic acid (DNA) abnormalities
(e.g., familial adenomatous polyposis, Fanconi-Bickel syndrome)
16. Have more than 4 hospitalizations related to PN/IV volume adjustments within 12 months of
Screening
17. Are not expected to be amenable to oral or tube feeding regimens
18. Have cardiac disease defined as decompensated heart failure (New York Heart Association Class IV),
unstable angina pectoris, and/or myocardial infarction within the last 6 months prior to screening
19.

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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