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MRG-201

Phase 1

Healthy Volunteers | Small molecule | Other |CASI Pharmaceuticals, Inc.|Last Updated: Jul 6, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

MRG-201 · 1 trial · 1 indication

Phase 1 1
NCT02603224Safety, Tolerability and Pharmacokinetic Study of MRG-201 in Healthy VolunteersHealthy Volunteers
COMPLETED54 Analytics
PHASE1COMPLETED
Safety, Tolerability and Pharmacokinetic Study of MRG-201 in Healthy Volunteers
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Study Endpoints

Primary Endpoints

Safety and tolerability of MRG-201 based on vital signs, physical examination, clinical laboratory tests, ECG, and incidence and severity of adverse events
Up to 43 days

Secondary Endpoints

Area under the plasma concentration vs. time curve (AUC) of MRG-201 following single and repeat doses
Up to 17 days
Peak plasma concentration (Cmax) of MRG-201 following single and repeat doses
Up to 17 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MRG-201EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
MRG-201DRUGIntradermal injection of single ascending doses and multiple ascending doses in healthy volunteers.
PlaceboDRUGIntradermal injection of placebo at a second site in healthy volunteers. Each subject will serve as their own control.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males between 18 and 45 years of age inclusive * Body Mass Index (BMI) 18-35 kg/m\^2 inclusive * Must have 2 regions on the lower back/upper buttocks free of striae, scars, tattoos or other skin pathologies * If engaged in sexual relations with a female of child-bearin...

Countries:Canada
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Frequently asked questions about MRG-201

What is MRG-201?

MRG-201 is an investigational small molecule being developed by CASI Pharmaceuticals, Inc. It is currently in Phase 1 clinical development. The drug has been studied in a completed clinical trial involving healthy volunteers to assess its safety, tolerability, and pharmacokinetics.

What is MRG-201 used for?

MRG-201 is being studied for use in healthy volunteers, as part of early-phase clinical development. The completed Phase 1 trial focused on evaluating the drug's safety, tolerability, and pharmacokinetic profile in this population. Its therapeutic use in specific diseases has not been established.

Who makes MRG-201?

MRG-201 is being developed by CASI Pharmaceuticals, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol CASI. CASI is responsible for the clinical development of this investigational small molecule drug.

What phase is MRG-201 in?

MRG-201 is in Phase 1 clinical development. The drug has completed one Phase 1 trial, which was a randomized, double-blind, placebo-controlled study in healthy volunteers. As an investigational drug, it is not yet approved and remains in clinical development.

What clinical trials is MRG-201 in?

MRG-201 has been studied in one completed clinical trial, identified as NCT02603224. This Phase 1 study, titled 'Safety, Tolerability and Pharmacokinetic Study of MRG-201 in Healthy Volunteers,' enrolled 54 male participants in Canada. The trial was randomized, double-blind, and placebo-controlled.

Is MRG-201 FDA approved?

MRG-201 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug has completed a Phase 1 trial in healthy volunteers, but it has not yet received regulatory approval for any indication.