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Drug Omega 3

Phase 1

Hypertriglyceridemia | Small molecule | Metabolic |Matinas Biopharma Holdings, Inc.|Last Updated: Oct 12, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

Drug Omega 3 · 1 trial · 1 indication

Phase 1 1
NCT02310022A PK and PD Study of Two Formulations of Omega-3 One Gram CapsulesHypertriglyceridemia
COMPLETED48 Analytics
PHASE1COMPLETED
A PK and PD Study of Two Formulations of Omega-3 One Gram Capsules
HypertriglyceridemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioavailability comparison after single and multiple doses over a 24 hour period at day 1 and day 14
14 Days

Area under the plasma concentration curve versus time curve (AUC0-tau) versus time curve (AUC0-tau) for both treatments measured over the 24 hour period on day 1 and day 14 \[ Time Frame: 14 days \]

Secondary Endpoints

Comparison of baseline changes of triglycerides and other related lipid protein parameter levels over 14 days
14 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Drug Omega 3EXPERIMENTAL4g (4 capsules) once a day, administered with food Other name MAT9001
Drug Omega 3 ComparatorACTIVE_COMPARATOR4g (4 capsules) once a day, administered with food Other name Omega 3 Active Comparator

Interventions

NameTypeDescription
Drug Omega 3DRUG4 g (4 capsules) once a day, administered with food
Drug Omega-3 ComparatorDRUG4 g (4 capsules) once a day, administered with food
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Subjects must fulfil all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified: 1. Adult male or female subject, 18-70 years of age, inclusive. 2. Light- or non-smoking, male and female subjects, 18 to 70 years of age. Not...

Countries:Canada
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Frequently asked questions about Drug Omega 3

What is Drug Omega 3 used for?

Drug Omega 3 is an investigational small molecule being developed for hypertriglyceridemia, a condition characterized by elevated levels of triglycerides in the blood. It is currently in Phase 1 clinical development.

Who makes Drug Omega 3?

Drug Omega 3 is being developed by Matinas Biopharma Holdings, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol MTNB.

What phase is Drug Omega 3 in?

Drug Omega 3 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study has been completed.

What clinical trials is Drug Omega 3 in?

Drug Omega 3 has one completed Phase 1 clinical trial, identified as NCT02310022, titled 'A PK and PD Study of Two Formulations of Omega-3 One Gram Capsules'. This trial enrolled 48 participants with hypertriglyceridemia in Canada.

Is Drug Omega 3 the same as omega-3?

Drug Omega 3 is a formulation of omega-3, specifically designed as one gram capsules. The clinical trial compared two formulations of these omega-3 capsules in patients with hypertriglyceridemia.