Short Bowel Syndrome-associated Intestinal Failure (SBS-IF) MedDRA version: 20.1 Level: PT Classification code 10049416 Term: Short-bowel syndrome System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: HM15912 (LAPS GLP-2 analog)
Product Code: HM15912 (LAPS GLP-2 analog)
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Human glucagon-like peptide-2
Sponsors
Hanmi Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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 kg/m² 9. Have stable body weight during the last 6 months prior to Screening (±5% variations allowed) 10. 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) 11. 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) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
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. Positive 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 (GFR) < 60mL/min/1.73m² by Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) 2021 16. Clinically significant laboratory abnormalities at the time of Screening, defined as having any of the following: a. Platelet count < 100 × 10³/µL b. White blood cells < 3.5 × 10³/µL c. Neutrophils < 1.5 × 10³/µL d. Hemoglobin levels < 8 g/dL 17. Persistent hepatic impairment defined by 2 of the following laboratory tests meeting the criteria below. Repeat tests done within 2 weeks apart must confirm the results. e. Total bilirubin =2 × the upper limit of normal (ULN), or f. Aspartate aminotransferase (AST) =5 × ULN, or g. 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. Any history of using the native GLP-2 or GLP-2 analog 20. Subject deemed by the Principal Investigator to be inappropriate for participation in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objectives: 1) To assess safety and tolerability of HM15912 after multiple subcutaneous (SC) doses for 24 weeks 2) To assess the pharmacokinetic (PK) profile of HM15912 ;Secondary Objective: To assess the pharmacodynamic (PD) profile of HM15912;Primary end point(s): 1) Primary endpoints to "assessment of safety and tolerability of HM15912 after multiple subcutaneous (SC) doses for 24 weeks: • Incidence of adverse events (AEs) • Incidence of injection site reactions • Incidence of clinical laboratory abnormalities • Clinically significant findings on physical examination • Changes from baseline in vital signs and 12-lead electrocardiogram (ECG) parameters 2) Primary endpoints to "assessment of the pharmacokinetic (PK) profile of HM15912": • Maximum serum concentration (Cmax) • Time to maximum serum concentration (tmax) • Elimination half-life (t1/2) • Volume of distribution (Vd/F) • Clearance (CL/F) • Area under the concentration-time curve from time zero to the last observable concentration (AUClast), AUC from time zero over the dosing interval at the 1st and 6th dosing, respectively (AUCtau and AUCtau,ss), and AUC extrapolated to infinity (AUC0-8);Timepoint(s) of evaluation of this end point: Throughout trial treatment/follow-up period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in weekly parenteral nutrition/intravenous fluid (PN/IV) volume from baseline to Week 25 Note: The baseline PN/IV volume (L/week) is the average of actual PN/IV volume received during the last 2 weeks of the Stabilization period. ;Timepoint(s) of evaluation of this end point: For time-point(s) see section E.5.2. | — |
Countries
Belgium, Denmark, France, Germany, Korea, Republic of, Poland, United States
Contacts
Public ContactChief Medical Officer's Office
Hanmi Pharmaceutical Co., Ltd.
Outcome results
None listed