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SAD448

Phase 1

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

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

Clinical trial landscape

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 Hypertension
NCT0050336080
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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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Competitive Landscape -Ocular Hypertension 8 trials

CompanyTickerTrialsLead PhaseDrugs
SpyGlass Pharma, Inc.SGP4PHASE3Bimatoprost System, Timolol, 0.5%
Amneal Pharmaceuticals, Inc. Class AAMRX2PHASE3Test- Bimatoprost 0.01%, Reference- LUMIGAN
AbbVie, Inc.ABBV1PHASE1AGN-193408
Glaukos CorpGKOS1 - Travoprost
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Frequently asked questions about SAD448

What is SAD448 used for?

SAD448 is an investigational small molecule being developed for the treatment of ocular hypertension, a condition characterized by elevated pressure inside the eye. It is being studied in the ophthalmology therapeutic area. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes SAD448?

SAD448 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical research to evaluate the safety, tolerability, and efficacy of this investigational drug for ocular hypertension.

What phase is SAD448 in?

SAD448 is in Phase 1 clinical development. A Phase 1 trial has been completed, which was designed to assess the tolerability, safety, and efficacy of the drug in subjects with ocular hypertension. The drug remains investigational and is not yet approved for commercial use.

What clinical trials is SAD448 in?

SAD448 has one completed clinical trial registered under NCT00503360, titled "Tolerability, Safety and Efficacy of SAD448 in Subjects With Ocular Hypertension." This Phase 1 study enrolled 80 participants in Australia, included adults aged 18 years and older, and was randomized and double-blind.

How does SAD448 work?

The specific molecular target or mechanism of action for SAD448 has not been disclosed in available information. It is classified as a small molecule drug being investigated for its potential to treat ocular hypertension, but the precise biological pathway through which it exerts its effects has not been publicly detailed.