Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GC5107 · 2 trials · 2 indications
AEs that occur during or within 1 hour, 24 hours, and 72 hours following each infusion during 12 months of the study period
The incidence of acute serious bacterial infections (aSBIs) meeting FDA guidance criteria, which includes bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscesses, and osteomyelitis/septic arthritis. Efficacy data is evaluated by comparing the frequency of acute serious bacterial infections per subject per year according to the FDA guideline of an upper one-sided 99% confidence limit \< 1.0 per subject per year.
The proportion of infusions with temporally associated adverse events occurring during or within 72 hours following infusion, whether or not they were thought to be related to GC5107
| Arm | Type | Description |
|---|---|---|
| GC5107 | EXPERIMENTAL | Immune Globulin Intravenous (Human), 10% Liquid |
| Name | Type | Description |
|---|---|---|
| GC5107 | BIOLOGICAL | Intravenously infused at a dose of 300 - 900 mg per kg (of body weight) every 21 or 28 days for 12 months |
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...
GC5107 is an investigational immune globulin intravenous (human) product being studied for the treatment of primary humoral immunodeficiency, a type of primary immune deficiency. It is intended to replace missing antibodies in patients with immunologic deficiency syndromes, helping to prevent infections.
GC5107 is being developed by Atlantic International Corp., a company traded under the ticker symbol ATLN. The company is conducting clinical trials to evaluate the safety and efficacy of this monoclonal antibody product in patients with primary immune deficiency.
GC5107 is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. Two Phase 3 trials have been conducted or are ongoing to assess its use in primary humoral immunodeficiency.
GC5107 has been studied in two Phase 3 trials. NCT02783482, completed, enrolled 49 subjects with primary humoral immunodeficiency in the United States and Canada. NCT04565015, active but not recruiting, is enrolling 24 pediatric subjects in the United States, Bosnia and Herzegovina, and Serbia.
GC5107 is an immune globulin intravenous (human) product, which provides passive immunity by delivering antibodies directly into the bloodstream. It is designed to supplement the deficient antibody levels in patients with primary humoral immunodeficiency, helping their immune system fight off infections.
GC5107 is a specific immune globulin intravenous (human) product developed by Atlantic International Corp. It is being studied specifically for primary humoral immunodeficiency. No alternative names for GC5107 have been disclosed in the clinical trial information.