Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
UB-421 · 2 trials · 1 indication
Numbers and incidence of TEAEs that are ≥ Grade 2 and study treatment related, TEAEs (any grades) by maximum severity, TEAEs by relationship to study treatment, SAEs, TEAEs leading to death, and TEAEs leading to discontinuation of study treatment will be tabulated by dose cohort and will be summarized by system organ class and preferred term for study period (Treatment or Follow-up). The "Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events" will be used in this study for all AE severity grading, except skin abnormalities, which will be evaluated according to Common Terminology Criteria for Adverse Events (CTCAE).
| Arm | Type | Description |
|---|---|---|
| cohort 1 | EXPERIMENTAL | Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly |
| cohort 2 | EXPERIMENTAL | Subjects will receive 8 doses of the UB-421 by intravenous infusion at 25 mg/kg weekly |
| Cohort A | EXPERIMENTAL | receive 4 weekly fixed doses of UB-421 SC at 250 mg |
| Cohort B | EXPERIMENTAL | receive 4 weekly fixed doses of UB-421 SC at 500 mg |
| Cohort C | EXPERIMENTAL | receive 4 weekly fixed doses of UB-421 SC at 700 mg |
| Name | Type | Description |
|---|---|---|
| UB-421 | DRUG | The UB-421 (dB4C7 mAb) will be supplied at a concentration of 10 mg/mL (100 mg in 10 mL vial). Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly (Cohort 1, 8 weeks) or 25 mg/kg bi-weekly (Cohort 2, 16 weeks). |
| UB-421 SC(dB4C7C22-6 mAb) | BIOLOGICAL | The UB-421 SC (dB4C7C22-6 mAb) will be supplied at a concentration of 125 mg/mL after reconstitution. Subjects will receive weekly UB-421 SC injections during the 4-week Treatment Period. |
Inclusion Criteria: * HIV-1 sero-positive * Aged 20 years or older * Have received HAART treatment * CD4+ T cell count ≧ 350 cells/mm3 * HIV-1 plasma RNA level remains below the limit of * Were not breastfeeding for women * Subjects with a negative serum pregnancy test result at screening visit for...
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UB-421 is an investigational monoclonal antibody being studied for the treatment of HIV-1 Infection. It is in Phase 2 clinical development and has been evaluated in clinical trials enrolling adults with HIV-1. The drug is not approved and remains under investigation for this infectious disease indication.
UB-421 is a monoclonal antibody, a type of biologic drug that binds to a specific target involved in the immune response. As an antibody-based therapy, it is designed to interact with components of the immune system to exert its antiviral activity against HIV-1. The exact molecular target has not been disclosed.
UB-421 is being developed by United Therapeutics Corporation, a publicly traded company listed on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical trials to evaluate the safety and efficacy of UB-421 in patients with HIV-1 Infection.
UB-421 is in Phase 2 clinical development for HIV-1 Infection. It has completed two clinical trials, including a Phase 2 study and a Phase 1 study. The drug is investigational and has not received FDA approval, as it is still being evaluated in clinical trials.
UB-421 has been studied in two completed clinical trials. NCT02369146 was a Phase 2 study evaluating the safety and efficacy of UB-421 monotherapy in HIV-infected adults in Taiwan. NCT04620304 was a Phase 1 study of a subcutaneous formulation in treatment-naive HIV-1 infected patients. Both trials enrolled adults aged 20 years and older.
UB-421 is a distinct investigational monoclonal antibody developed by United Therapeutics Corporation. It is not known to be the same as any other approved or investigational drug. Its unique mechanism and development program differentiate it from other HIV-1 therapies.