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GC5107

Phase 3

Primary Immune Deficiency | Monoclonal antibody | Other |Atlantic International Corp.|Last Updated: Jul 25, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04565015Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral ImmunodeficiencyPHASE3 ACTIVE NOT_RECRUITING 24 — — Dec 21, 2020Nov 1, 2026Jul 25, 20258 United States, Bosnia and Herzegovina +1
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Study Endpoints
Primary Endpoints
The Pharmacokinetic (PK) Plasma concentration-time curve of total IgG
before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Half-life of total IgG
before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Area under the curve of total IgG
before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Volume of distribution of total IgG
before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Maximum concentration of total IgG
before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Minimum concentration of total IgG
before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Time of maximum concentration of total IgG
before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Clearance of total IgG
before and after 5th infusion (12 or 16 weeks)
Trough serum total IgG levels before each infusion of GC5107 in all subjects and the interval between infusions
12 months
The proportion of infusions with temporally associated adverse events (AEs) that occur during or within 1 hour, 24 hours, and 72 hours following an infusion of investigational product
12 months

AEs that occur during or within 1 hour, 24 hours, and 72 hours following each infusion during 12 months of the study period

Secondary Endpoints
The Pharmacokinetic (PK) Maximum concentration of IgG subclasses
before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Minimum concentration of IgG subclasses
before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Half-life of IgG subclasses
before and after 5th infusion (12 or 16 weeks)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GC5107EXPERIMENTALImmune Globulin Intravenous (Human), 10% Liquid
Interventions
NameTypeDescription
GC5107BIOLOGICALIntravenously infused at a dose of 300 - 900 mg per kg (of body weight) every 21 or 28 days for 12 months
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Eligibility Criteria
Age Range2 Years — 16 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Subject must be ≥ 2 to \< 17 years of age, at the time of signing the informed consent * Pediatric subject has a confirmed and documented clinical diagnosis of Primary Humoral Immunodeficiency, including hypogammaglobulinemia or agammaglobulinemia * Subject who has received 30...

Countries:United StatesBosnia and HerzegovinaSerbia
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT04565015studyFirstPostDate: changed