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RSV604

Phase 1

Healthy | Small molecule | Other |Novartis AG|Last Updated: Nov 2, 2011

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

Clinical trial landscape

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 used for?

RSV604 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in Phase 1 clinical development. The only completed trial evaluated its safety, tolerability, and pharmacokinetics after single and multiple intravenous doses in healthy subjects.

Who makes RSV604?

RSV604 is being developed by Novartis AG, which trades under the ticker NVS. The company sponsored a Phase 1 study of the drug in healthy volunteers in the United Kingdom.

What phase is RSV604 in?

RSV604 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed.

What clinical trials is RSV604 in?

RSV604 has one completed clinical trial, NCT00416442, titled 'Safety, Tolerability and Pharmacokinetic Study of Single and Multiple Intravenous Doses of RSV604 in Healthy Subjects.' This Phase 1 study enrolled 48 participants in the United Kingdom and was completed.

Is RSV604 FDA approved?

RSV604 is not FDA approved. It is an investigational drug in Phase 1 clinical development. The only completed trial was a Phase 1 study in healthy volunteers, and no approval has been granted.