Hypoglycaemia associated with congenital hyperinsulinism MedDRA version: 19.0 Level: LLT Classification code 10020644 Term: Hyperinsulinism NOS System Organ Class: 100000004861 MedDRA version: 19.0 Level: LLT Classification code 10022484 Term: Insulin hypoglycaemia System Organ Class: 100000004861
Conditions
Interventions
Product Name: XOMA 358
Product Code: XOMA 358
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: imunoglobulin G 2 (IgG2)
C
Sponsors
XOMA (US) LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provide written informed consent and, as applicable, assent, before any study-specific procedures are performed 2. Aged at least 12 years at Screening 3. An established clinical diagnosis, with or without a genetic diagnosis, of congenital hyperinsulinism 4. Duration of glucose levels =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Any out-of-range laboratory value at Screening that has not been reviewed, approved, and documented as not clinically significant by the Investigator, with the exception of liver function tests for total bilirubin, ALT, AST, and ALP, which must be within 1.5X the upper limit of normal (UNL) for the reference range 2. During confinement, use of any agent, such as diazoxide, octreotide, chronic systemic glucocorticoids, or ß agonists, that may affect glucose metabolism. Such agents will be washed out after checking-in to the in-patient research facility and before dosing. Topical, inhaled, and intranasal corticosteroids at doses that are unlikely to affect glucose homeostasis and corticosteroids for ophthalmic use are permitted. 3. Body Mass Index = 35 kg/m2 4. History of malignancy within 3 years before Screening other than carcinoma in situ of the cervix or adequately treated nonmetastatic squamous or basal cell carcinoma of the skin 5. History of seropositivity for HIV antibody, hepatitis B, or hepatitis C antibody 6. Major general surgery within 3 months before Screening or anticipated during the study period 7. Known allergy or sensitivity to XOMA 358 or any component of the study drug 8. Treatment with an investigational drug or device within 30 days or 5 half-lives of the investigational drug before Day 1, whichever is longer. Participation in registries and purely diagnostic studies is allowed. 9. Female subjects who are pregnant, planning to become pregnant during the course of the study, have recently delivered (within 3 months before Screening), or are breast- feeding 10. Male subjects who are planning a pregnancy with a female partner during the course of the study or within 4 months after administration of study drug 11. Any organ condition, concomitant disease (eg, psychiatric illness, severe alcoholism, or drug abuse, cardiac, hepatic, or kidney disease), or other abnormality that itself, or the treatment of which, could interfere with the conduct of the study (eg, may affect absorption, distribution, metabolism, or elimination of the study drug) or that, in the opinion of the Investigator and/or Sponsor’s medical monitor, would pose an unacceptable risk to the subject in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and clinical pharmacology of a single dose of XOMA 358 in subjects with hypoglycaemia associated with congenital hyperinsulinism.;Secondary Objective: Not applicable;Primary end point(s): Effect on Glucose (Glucose AUC24, average time per day of blood glucose < 70 mg/dL);Timepoint(s) of evaluation of this end point: Measured at various time points (see schedule of events) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of hypoglycemic events per day with glucose < 70 mg/dL, <60 mg/dL, and <50 mg/dL Fasting and postprandial glucose, insulin, C-peptide, ketones, free fatty acids; Time to hypoglycaemia; Frequency of hypoglycemia events (<60 mg/dL) Concomitant treatment/medications used during rescue ;Timepoint(s) of evaluation of this end point: Measured at various time points (see schedule of events) | — |
Countries
United Kingdom, United States
Contacts
Public ContactBioDesk
Clinical Networks Services (UK) Ltd
Outcome results
None listed