Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TJ003234 · 2 trials · 2 indications
Free of mechanical ventilation was defined as proportion of subjects who scores 1 to 5 in the following 8-category ordinal scale. 8, death; 7, ventilation in addition to extracorporeal membrane oxygen (ECMO), continuous renal replacement therapy (CRRT) or pressors; 6, intubation and mechanical ventilation; 5, non-invasive mechanical ventilation (NIV) or high-flow oxygen; 4, hospitalization with oxygen by mask or nasal prongs; 3. Hospitalization without oxygen supplementation; 2, limitation of activities, discharge from hospital; and 1, no limitation of activities, discharge from hospital.
Incidence of Adverse Events (AEs)
Determine Maximum Tolerated Dose of TJ003234
| Arm | Type | Description |
|---|---|---|
| TJ003234 Medium Dose | EXPERIMENTAL | - |
| TJ003234 Low Dose | EXPERIMENTAL | Part 1 only |
| Placebo | PLACEBO_COMPARATOR | - |
| TJ003234 High Dose | EXPERIMENTAL | Part 2 Phase 3 only |
| TJ003234 | EXPERIMENTAL | 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg via single IV infusion |
| Name | Type | Description |
|---|---|---|
| TJ003234 | DRUG | patients receive a single infusion |
| Placebo | DRUG | patients receive a single infusion |
Inclusion Criteria: * Age: 18 years or older (including 18 years); male or female * Laboratory-confirmed SARS-CoV-2 or COVID-19 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay. * Bilateral lung infection confirmed by imaging. * Severe disease th...
TJ003234 is an investigational anti-GM-CSF monoclonal antibody being studied for use in healthy adult subjects and in patients with severe Coronavirus Disease 2019 (COVID-19). It is being developed by I-Mab Biopharma (ticker: NBP) as a potential treatment for COVID-19.
TJ003234 targets GM-CSF, a cytokine involved in inflammation. By binding to GM-CSF, the antibody aims to modulate the immune response. It is being investigated for its potential role in treating severe COVID-19, where excessive inflammation can contribute to disease severity.
TJ003234 is being developed by I-Mab Biopharma, a biopharmaceutical company listed under the ticker NBP. The company is conducting clinical trials to evaluate the drug's safety and efficacy in healthy volunteers and in patients with severe COVID-19.
TJ003234 is in Phase 2 clinical development for severe COVID-19. A Phase 1 study in healthy adult subjects has been completed. The drug is investigational and has not been approved by regulatory authorities for any use.
TJ003234 has been studied in two completed clinical trials. NCT03794180 was a Phase 1 study in healthy adult subjects with 32 participants. NCT04341116 was a Phase 2 study in patients with severe COVID-19, enrolling 149 participants. Both trials were conducted in the United States.
Yes, TJ003234 is an anti-GM-CSF monoclonal antibody. It is designed to bind to and neutralize GM-CSF, a protein that promotes inflammation. This mechanism is being explored as a therapeutic approach for severe COVID-19, where uncontrolled inflammation can lead to lung damage.