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UB-421 Q2W

Phase 2

HIV-1 Infection | Monoclonal antibody | Infectious Disease |United Therapeutics Corporation|Last Updated: May 13, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedNO_TREATMENT_CONTROLLED
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

UB-421 Q2W · 1 trial · 1 indication

Phase 2 1
NCT03743376The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 PatientsHIV-1 Infection
COMPLETED31 Analytics
PHASE2COMPLETED
The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients
HIV-1 InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

treatment related TEAEs
48Weeks

the incidence of Grade 3 drug-related treatment-emergent adverse events

Secondary Endpoints

the change of immune profiles
16Weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Standard ARTNO_INTERVENTIONSubjects will receive standard ART for 48 weeks
UB-421(25mg/kg) Q2W add-on treatmentEXPERIMENTALUB-421(25 mg/kg) Q2W plus standard ART for 48 weeks
UB-421(25mg/kg) Q4W add-on treatmentEXPERIMENTALUB-421(25 mg/kg) Q4W plus standard ART for 48 weeks

Interventions

NameTypeDescription
UB-421(25 mg/kg) Q2WBIOLOGICALMonoclonal antibody by IV infusion plus standard ART
UB-421(25 mg/kg) Q4WBIOLOGICALMonoclonal antibody by IV infusion plus standard ART
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Eligibility Criteria

Age Range20 Years to 100 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. HIV-1 sero-positive 2. Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg. 3. HIV-1 plasma RNA level below 50 RNA copies/mL . Exclusion Criteria: 1. Subjects with active systemic infections, except for HIV-1, that the Investigator feels the infections may conf...

Countries:Taiwan
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Frequently asked questions about UB-421 Q2W

What is UB-421 Q2W used for?

UB-421 Q2W is a monoclonal antibody being developed for the treatment of HIV-1 infection. It is currently in Phase 2 clinical development and is being studied for its potential to achieve a functional cure in patients with HIV-1 who have stabilized on antiretroviral therapy.

Who makes UB-421 Q2W?

UB-421 Q2W 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 drug's safety and efficacy in patients with HIV-1 infection.

What phase is UB-421 Q2W in?

UB-421 Q2W is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 clinical trial has been completed to evaluate its potential in treating HIV-1 infection.

What clinical trials is UB-421 Q2W in?

UB-421 Q2W has been studied in one completed Phase 2 clinical trial with the identifier NCT03743376. This trial, titled 'The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients,' enrolled 31 participants with HIV-1 infection in Taiwan and evaluated the drug's potential for achieving a functional cure.

Is UB-421 Q2W the same as UB-421?

UB-421 Q2W is a specific dosing regimen of the monoclonal antibody UB-421, administered every two weeks. The drug is being developed by United Therapeutics Corporation for the treatment of HIV-1 infection and is currently in Phase 2 clinical development.