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MRG-110

Phase 1

Healthy Volunteer | Small molecule | Other |CASI Pharmaceuticals, Inc.|Last Updated: May 7, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

MRG-110 · 1 trial · 1 indication

Phase 1 1
NCT03603431Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MRG-110 Following Intradermal Injection in Healthy VolunteersHealthy Volunteer
COMPLETED42 Analytics
PHASE1COMPLETED
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MRG-110 Following Intradermal Injection in Healthy Volunteers
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Study Endpoints

Primary Endpoints

Number of participants with treatment-related adverse events as assessed by CTCAE v4.03.
Up to Day 55

Secondary Endpoints

Area under the plasma concentration vs. time curve (AUC) of MRG-110 following single and repeat doses.
Up to Day 45
Peak plasma concentration (Cmax) of MRG-110 following single and repeat doses
Up to Day 45
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single Ascending Dose - MRG-110EXPERIMENTALIntradermal injection of MRG-110 at two wound sites and intradermal injection of placebo at two other wound sites
Single Ascending Dose - PlaceboPLACEBO_COMPARATORIntradermal injection of placebo at four wound sites
Multiple Ascending Dose - MRG-110EXPERIMENTALIntradermal injection of MRG-110 at two wound sites and intradermal injection of placebo at two other wound sites
Multiple Ascending Dose - PlaceboPLACEBO_COMPARATORIntradermal injection of placebo at four wound sites

Interventions

NameTypeDescription
MRG-110DRUGSingle ascending doses of MRG-110
PlaceboDRUGSingle doses of placebo
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Eligibility Criteria

Age Range19 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Normal healthy volunteers. * Females must be of non-childbearing potential. * If engaged in sexual relations with a female of child-bearing potential, males must be surgically sterile or must be willing to use a highly effective method of contraception throughout their stu...

Countries:United States
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Frequently asked questions about MRG-110

What is MRG-110 used for?

MRG-110 is an investigational small molecule being studied for use in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its safety, tolerability, pharmacokinetics, and pharmacodynamics following intradermal injection.

Who makes MRG-110?

MRG-110 is being developed by CASI Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol CASI. The company is conducting clinical research on this investigational small molecule in the United States.

What phase is MRG-110 in?

MRG-110 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, involving 42 healthy volunteers in the United States.

What clinical trials is MRG-110 in?

MRG-110 has one completed clinical trial, identified as NCT03603431. This Phase 1 study assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of MRG-110 following intradermal injection in healthy volunteers. The trial was randomized, double-blind, and placebo-controlled.

Is MRG-110 the same as any other drug?

No alternative names for MRG-110 have been reported. It is identified solely by the code name MRG-110 in clinical trial records and is being developed as a distinct investigational small molecule by CASI Pharmaceuticals.