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SAD448

Phase 1

Ocular Hypertension | Small molecule | Ophthalmology |Novartis AG|Trials Updated: Apr 24, 2008

SAD448 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2007

SAD448 target and mechanism

Molecular targetCNR1, CNR2
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

SAD448 clinical trials

SAD448 · 1 trial · 1 indication

Phase 1 1
NCT00503360Tolerability, Safety and Efficacy of SAD448 in Subjects With Ocular HypertensionOcular Hypertension
COMPLETED80 Analytics
PHASE1COMPLETED
Tolerability, Safety and Efficacy of SAD448 in Subjects With Ocular Hypertension
Ocular HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, ECGs and vital signs from baseline up to 24 hours post-dosing.

Secondary Endpoints

Change in ocular hypertension from baseline up to 24 hours post-dosing. Systemic exposure to SAD448 following the administration of two doses.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
SAD448DRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Key inclusion criteria: * Males and females, 18 - 65 years of age, with ocular hypertension * Females must be post-menopausal or surgically sterile Key exclusion criteria: * Diagnosis of glaucoma in either eye * A history of or current eye conditions or medical problems that would prohibit the us...

Countries:Australia
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Frequently asked questions about SAD448

What is SAD448?

SAD448 is an investigational small molecule developed by Novartis AG for ocular hypertension, a condition of elevated pressure inside the eye. It was studied as a Phase 1 candidate in a single completed clinical trial. SAD448 has not been approved by the FDA and remains in clinical development.

What is SAD448 used for?

SAD448 was developed for the treatment of ocular hypertension, a condition in which pressure within the eye is elevated. Its only recorded clinical study enrolled adults with ocular hypertension. The drug is investigational and has not been approved for any use.

What does SAD448 target?

SAD448 targets the cannabinoid receptors CNR1 and CNR2. It acts as an agonist at these receptors, meaning it activates them. Both receptors are part of the endocannabinoid system. This target profile was the basis for its development as a small molecule for ocular hypertension.

Who makes SAD448?

SAD448 is developed by Novartis AG, the Swiss pharmaceutical company whose shares trade under the ticker NVS. Novartis sponsored the Phase 1 study of SAD448 in ocular hypertension. No other developer or partner is associated with the asset.

What phase is SAD448 in?

SAD448 is in Phase 1 development. Its only recorded clinical trial, NCT00503360, was a Phase 1 study that has been completed. The drug is investigational and has not received FDA approval. No active trials of SAD448 are currently listed.

What clinical trials is SAD448 in?

SAD448 has been studied in one clinical trial, NCT00503360, titled Tolerability, Safety and Efficacy of SAD448 in Subjects With Ocular Hypertension. The Phase 1 trial was randomized, double blind, and enrolled 80 participants in Australia. It is completed, and no active trials are listed.