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AGG-523

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jul 29, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

Clinical trial landscape

AGG-523 · 4 trials · 3 indications

Phase 1 4
NCT00454298Study Evaluating AGG-523 in Subjects With Severe Osteoarthritis Requiring Total Knee ReplacementOsteoarthritis
COMPLETED2 Analytics
NCT00427687Study Evaluating AGG-523 in Subjects With OsteoarthritisOsteoarthritis
COMPLETED- Analytics
NCT00434785A Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 in Healthy Japanese MalesHealthy
COMPLETED- Analytics
NCT00380900Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses in HealthyHealthy Subjects
COMPLETED- Analytics
PHASE1COMPLETED
Study Evaluating AGG-523 in Subjects With Severe Osteoarthritis Requiring Total Knee Replacement
OsteoarthritisUnlock trial analytics
PHASE1COMPLETED
Study Evaluating AGG-523 in Subjects With Osteoarthritis
OsteoarthritisUnlock trial analytics
PHASE1COMPLETED
A Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 in Healthy Japanese Males
HealthyUnlock trial analytics
PHASE1COMPLETED
Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses in Healthy
Healthy SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

Using parts of the knee joint and the surrounding fluid that is taken out at the time of knee replacement, measure 1) the activity of aggrecansase (an enzyme that breaks down cartilage) and 2) the amount of study drug using lab tests.
4 weeks
The effect of AGG-523 on biomarkers related to osteoarthritis.
To assess the safety and PK profile
Assess the safety of multiple doses of AGG-523 administered to subjects.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AACTIVE_COMPARATORAGG-523 1800 mg QD PO (12 capsules) for 28 days
BACTIVE_COMPARATORAGG-523 900 mg BID PO (12 capsules) for 28 days
CPLACEBO_COMPARATORPlacebo QD PO (12 capsules) for 28 days
DPLACEBO_COMPARATORPlacebo BID PO (12 capsules) for 28 days

Interventions

NameTypeDescription
AGG-523 (Aggrecanase Inhibitor)DRUG -
AGG-523DRUG -
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Eligibility Criteria

Age Range55 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Generally healthy, men or women, at least 55 years old * Osteoarthritis of the knee requiring total knee replacement surgery Exclusion Criteria: * Other types of arthritis, like rheumatoid arthritis * Recent major surgery (in past 3 months) * Recent knee injections (in past ...

Countries:United StatesJapan
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Frequently asked questions about AGG-523

What is AGG-523 used for?

AGG-523 is an investigational small molecule being studied for use in osteoarthritis. It has been evaluated in Phase 1 clinical trials involving healthy subjects and patients with osteoarthritis, including those with severe osteoarthritis requiring total knee replacement.

Who makes AGG-523?

AGG-523 is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE on the New York Stock Exchange.

What phase is AGG-523 in?

AGG-523 is in Phase 1 clinical development. It has completed multiple Phase 1 trials, but it is not approved by the FDA and remains an investigational drug.

What clinical trials is AGG-523 in?

AGG-523 has been studied in several completed Phase 1 trials, including NCT00380900, NCT00427687, NCT00434785, and NCT00454298. These trials evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy subjects and patients with osteoarthritis.

Is AGG-523 the same as any other drug?

No alternative names for AGG-523 have been disclosed. It is identified solely by the code name AGG-523 in clinical trial registrations.