Trials / Completed
CompletedNCT02604485
A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism
A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism (HI)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- XOMA (US) LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and clinical pharmacology of a single dose pharmacokinetics and pharmacodynamics of XOMA 358 in subjects with hypoglycemia associated with congenital hyperinsulinism.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cohort 1 | XOMA 358 single dose level A administered by an intravenous infusion |
| DRUG | Cohort 2 | XOMA 358 single dose level B administered by an intravenous infusion |
| DRUG | Cohort 3 | XOMA 358 single dose level C administered by an intravenous infusion |
| DRUG | Cohort 4 | XOMA 358 single dose level D administered by an intravenous infusion |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2017-01-01
- Completion
- 2017-01-01
- First posted
- 2015-11-13
- Last updated
- 2017-02-06
Locations
2 sites across 2 countries: United States, United Kingdom
Source: ClinicalTrials.gov record NCT02604485. Inclusion in this directory is not an endorsement.