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XOMA 358 single

Phase 2

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

Target and mechanism

ModalitySmall molecule

Also known as XOMA 358 single dose level A

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

XOMA 358 single · 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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