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RI-001

Phase 2

Upper Respiratory Tract Infection | Monoclonal antibody | Infectious Disease |ADMA Biologics Inc|Last Updated: Apr 24, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

RI-001 · 1 trial · 2 indications

Phase 2 1
NCT00632463RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV IllnessUpper Respiratory Tract Infection
COMPLETED21 Analytics
PHASE2COMPLETED
RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness
Upper Respiratory Tract Infection
NCT0063246321
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Study Endpoints

Primary Endpoints

Circulating RI-001 Titer
Study day 18

The primary endpoint of this study was the mean fold titer increase from baseline to Day 18 in circulating serum anti-RSV neutralizing antibody following treatment with RI-001.

Secondary Endpoints

Incidence of RSV Progression From Symptomatic Upper Respiratory Tract Infection to Lower Respiratory Tract Infection.
Study day 33
The Number of Patients Achieving at Least a 4-fold Increase in Serum RSV Neutralizing Antibody Titers
18 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALDose regimen 1
2EXPERIMENTALDose regimen 2
3PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
RI-001BIOLOGICALDose 1
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Eligibility Criteria

Age Range2 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: 1. An IEC/IRB approved written informed consent signed and dated by the patient or by parent(s) or a legally acceptable representative. The consent form or a specific assent form, where required, will be signed and dated by minors. 2. Documented Bone Marrow Transplant (BMT)/Hema...

Countries:United StatesCanada
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Frequently asked questions about RI-001

What is RI-001 used for?

RI-001 is a monoclonal antibody being developed for the treatment of upper respiratory tract infection, specifically in immunosuppressed patients infected with respiratory syncytial virus (RSV) who are at risk of lower tract RSV illness. It is currently in Phase 2 clinical development.

What does RI-001 target?

RI-001 is a monoclonal antibody that targets respiratory syncytial virus (RSV). It is designed to neutralize the virus and is being studied in immunosuppressed patients with upper respiratory tract RSV infection who are at risk of developing lower respiratory tract illness.

Who makes RI-001?

RI-001 is being developed by ADMA Biologics Inc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ADMA. The company is conducting clinical trials to evaluate the safety and efficacy of this monoclonal antibody in patients with respiratory syncytial virus infection.

What phase is RI-001 in?

RI-001 is in Phase 2 clinical development. It is an investigational monoclonal antibody and has not yet been approved by regulatory authorities. A Phase 2 clinical trial has been completed to evaluate its use in immunosuppressed patients with respiratory syncytial virus infection.

What clinical trials is RI-001 in?

RI-001 has been studied in one clinical trial, identified as NCT00632463, titled 'RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness.' This Phase 2, randomized, double-blind, placebo-controlled trial enrolled 21 participants and was conducted in the United States and Canada.

Is RI-001 the same as a standard RSV treatment?

RI-001 is a monoclonal antibody specifically developed for respiratory syncytial virus (RSV) infection. It is not a standard treatment but an investigational therapy being evaluated in clinical trials. Its mechanism involves targeting RSV to prevent progression from upper to lower respiratory tract illness in immunosuppressed patients.