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RSV604

Phase 1

Undisclosed | Small molecule | Other |Novartis AG|Trials Updated: Nov 2, 2011

RSV604 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Dec 2006

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

RSV604 clinical trials

RSV604 · 1 trial · 1 indication

Phase 1 1
NCT00416442Safety, Tolerability and Pharmacokinetic Study of Single and Multiple Intravenous Doses of RSV604 in Healthy Subjects.Healthy
COMPLETED48 Analytics
PHASE1COMPLETED
Safety, Tolerability and Pharmacokinetic Study of Single and Multiple Intravenous Doses of RSV604 in Healthy Subjects.
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Study Endpoints

Primary Endpoints

Safety and tolerability of single and multiple intravenous doses of RSV604 as measured by vital signs, electrocardiographs (ECGs), adverse events, clinical laboratory evaluations.
Tolerability of single and multiple intravenous doses of RSV604, RSV604 as measured by vital signs, ECGs, adverse events, clinical laboratory evaluations

Secondary Endpoints

Pharmacokinetics of single-dose RSV604 intravenous formulation administered orally and intravenously
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
RSV604DRUG -
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female subjects, 18-50 years of age, in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. * Vital signs within the following parameters: oral body temperature between 35...

Countries:United Kingdom
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Frequently asked questions about RSV604

What is RSV604?

RSV604 is an investigational small molecule drug developed by Novartis AG. It was studied in a Phase 1 clinical trial evaluating its safety, tolerability, and pharmacokinetics in healthy adult subjects. RSV604 has not been approved by the FDA and remains in early-stage clinical development.

Who makes RSV604?

RSV604 is developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the Phase 1 clinical trial of RSV604 conducted in the United Kingdom. The drug is an investigational small molecule and has not received regulatory approval.

What phase is RSV604 in?

RSV604 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug has not been approved by the FDA and remains investigational.

What clinical trials is RSV604 in?

RSV604 has been studied in one completed Phase 1 clinical trial, NCT00416442, titled Safety, Tolerability and Pharmacokinetic Study of Single and Multiple Intravenous Doses of RSV604 in Healthy Subjects. The trial enrolled 48 healthy adult participants in the United Kingdom and is now completed.

What was the design of the RSV604 Phase 1 trial?

The Phase 1 trial NCT00416442 was a randomized, double-blind study of single and multiple intravenous doses of RSV604 in 48 healthy adult subjects. It was conducted in the United Kingdom and has been completed. The trial evaluated safety, tolerability, and pharmacokinetics.