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PAT-1251

Phase 1

Healthy | Small molecule | Other |Damora Therapeutics, Inc.|Last Updated: Nov 30, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment78

FDA Designations

No designations recorded

Clinical trial landscape

PAT-1251 · 1 trial · 1 indication

Phase 1 1
NCT02852551Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of PAT-1251 in Healthy Adult SubjectsHealthy
COMPLETED78 Analytics
PHASE1COMPLETED
Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of PAT-1251 in Healthy Adult Subjects
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Study Endpoints

Primary Endpoints

Incidence of Treatment-Emergent Adverse Events
one to seven days

Determination of adverse events will include assessment of vital signs, ECG, clinical laboratory and physical examination

Secondary Endpoints

Maximum Observed Plasma Concentration (Cmax)
one to seven days
Area Under the Plasma Concentration Versus Time Curve (AUC)
one to seven days
Time to Maximum Observed Plasma Concentration (Tmax)
one to seven days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
PAT-1251 Single DoseEXPERIMENTALOral solution of PAT-1251, 150 - 4000 mg administered once
Placebo Single DosePLACEBO_COMPARATORMatching placebo solution administered once
PAT-1251 Multiple DoseEXPERIMENTALOral tablet(s) of PAT-1251 up to 2000 mg administered daily for 7 days
Placebo Multiple DoseEXPERIMENTALMatching placebo tablets administered daily for 7 days

Interventions

NameTypeDescription
PAT-1251DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive * body weight of 50 to 100 kg, inclusive * subjects must be in good health Exclusion Criteria: * male subjects who do not agree, or whose partners of childbearing potential do not agree, to use appropriate contrace...

Countries:United Kingdom
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Frequently asked questions about PAT-1251

What is PAT-1251 used for?

PAT-1251 is an investigational small molecule being studied for use in healthy adult subjects. It is currently in Phase 1 clinical development, with a completed trial evaluating its safety, tolerability, and pharmacokinetics in healthy volunteers.

Who makes PAT-1251?

PAT-1251 is being developed by Damora Therapeutics, Inc., a biopharmaceutical company. The company's stock trades under the ticker symbol DMRA.

What phase is PAT-1251 in?

PAT-1251 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial has been completed, and the drug remains in early-stage clinical testing.

What clinical trials is PAT-1251 in?

PAT-1251 has one completed clinical trial, NCT02852551, titled 'Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of PAT-1251 in Healthy Adult Subjects.' This Phase 1 study enrolled 78 participants in the United Kingdom.

Is PAT-1251 being studied in healthy volunteers?

Yes, PAT-1251 is being studied in healthy volunteers. The completed Phase 1 trial NCT02852551 enrolled healthy adult subjects aged 18 years and older, with a placebo-controlled, double-blind, randomized design.