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XOMA 358 single dose level A

Phase 2

Hypoglycemia | Small molecule | Metabolic |XOMA Royalty Corporation|Last Updated: May 21, 2021

Success Probability

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

XOMA 358 single dose level A · 1 trial · 1 indication

Phase 2 1
NCT02772718An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass SurgeryHypoglycemia
COMPLETED20 Analytics
PHASE2COMPLETED
An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery
Hypoglycemia
NCT0277271820
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Study Endpoints

Primary Endpoints

Single dose Part 1 and Multiple dose Part 2 - Incidence of treatment-emergent adverse events -
42 days

Safety assessed by treatment-emergent adverse events

Single dose Part 1 - Change from baseline in glucose levels
Baseline and 22 days

Glucose measured using a continuous glucose monitor

Single dose Part 1 - Blood glucose levels
Daily through Day 11 and at Day 22

Assessment of blood glucose with a bedside meter at multiple time points specified in the protocol

Multiple dose Part 2 - Change from baseline of duration of glucose by CGM at various levels as specified in the protocol
28 days

Glucose measured by continuous glucose monitoring every 5 min

Multiple dose Part 2 - Change from baseline of number of episodes and percent of episodes of hypoglycemia per day with glucose by CGM at various levels as defined in the protocol
28 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1 - single doseEXPERIMENTALCohorts A, B, and C
Part 2 - multiple dosesEXPERIMENTALCohort 1

Interventions

NameTypeDescription
XOMA 358 single dose level ADRUGXOMA 358 single dose level A administered by intravenous infusion
XOMA 358 single dose level BDRUGXOMA 358 single dose level B administered by an intravenous infusion
XOMA 358 single dose level CDRUGXOMA 358 single dose level C administered by an intravenous infusion
XOMA 358 multiple dose level 1DRUGXOMA 358 multiple dose level 1 administered by an intravenous infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Aged at least 18 years of age * Body Mass Index \< 35 kg/m2 at baseline, unless discussed with Medical Monitor and patients with higher body mass index do not have significant medical co-morbidities that would confound ability to assess safety and efficacy of study drug. * Rec...

Countries:United States
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Frequently asked questions about XOMA 358 single dose level A

What is XOMA 358 single dose level A used for?

XOMA 358 single dose level A is an investigational small molecule being developed for the treatment of hypoglycemia, specifically in patients who experience hypoglycemia after gastric bypass surgery. It is currently in Phase 2 clinical development and has been studied in a completed clinical trial.

Who makes XOMA 358 single dose level A?

XOMA 358 single dose level A is being developed by XOMA Royalty Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol XOMA. The company is conducting clinical research on this investigational therapy for hypoglycemia.

What phase is XOMA 358 single dose level A in?

XOMA 358 single dose level A is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy for treating hypoglycemia.

What clinical trials is XOMA 358 single dose level A in?

XOMA 358 single dose level A has been studied in one completed clinical trial, identified as NCT02772718. This was an open-label, Phase 2 study titled 'An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery,' which enrolled 20 participants in the United States.

Is XOMA 358 single dose level A the same as XOMA 358?

Yes, XOMA 358 single dose level A is a specific dose level of the drug XOMA 358. The clinical trial NCT02772718 evaluated XOMA 358 in patients with hypoglycemia after gastric bypass surgery, and the single dose level A refers to one of the doses tested in that study.