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TT301

Phase 1

Traumatic Brain Injury | Small molecule | Neurology |Opko Health Inc.|Last Updated: Jun 6, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

TT301 · 1 trial · 1 indication

Phase 1 1
NCT01357421Effects of TT301 on Cytokine Levels Post Endotoxin ChallengeTraumatic Brain Injury
COMPLETED18 Analytics
PHASE1COMPLETED
Effects of TT301 on Cytokine Levels Post Endotoxin Challenge
Traumatic Brain InjuryUnlock trial analytics

Study Endpoints

Primary Endpoints

Cytokine levels post LPS challenge
Measured up to 12h post-LPS
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TT301EXPERIMENTALInvestigational drug TT301
PlaceboPLACEBO_COMPARATORNormal saline

Interventions

NameTypeDescription
TT301DRUGSingle iv dose of TT301
PlaceboDRUGSingle iv dose of 0.9% sodium chloride for injection USP
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Eligibility Criteria

Age Range18 Years to 40 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male * 18 to 40 years, inclusive * 55 - 95 kg, inclusive Exclusion Criteria: * Evidence of any clinically significant disease * History of cancer * History of syncope or severe vasovagal events * Antibiotic treatment within 60 days of Day 1 * Surgical procedure within 60 day...

Countries:United States
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Frequently asked questions about TT301

What is TT301 used for?

TT301 is an investigational small molecule being developed for traumatic brain injury. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied for its effects on cytokine levels following an endotoxin challenge in healthy volunteers.

Who makes TT301?

TT301 is being developed by Opko Health Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol OPK. The drug is currently in Phase 1 clinical development for traumatic brain injury.

What phase is TT301 in?

TT301 is in Phase 1 clinical development. It has completed one Phase 1 trial, which was a randomized, double-blind, placebo-controlled study. The drug is investigational and has not been approved by the FDA.

What clinical trials is TT301 in?

TT301 has one completed clinical trial, NCT01357421, titled 'Effects of TT301 on Cytokine Levels Post Endotoxin Challenge.' This Phase 1 study enrolled 18 healthy male volunteers in the United States and was placebo-controlled.

How does TT301 work?

TT301 is a small molecule being studied for traumatic brain injury. The completed Phase 1 trial evaluated its effects on cytokine levels following an endotoxin challenge, suggesting it may modulate inflammatory responses. However, its specific molecular target has not been disclosed.