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MRG-110

Phase 1

Undisclosed | Small molecule | Other |CASI Pharmaceuticals, Inc.|Trials Updated: May 7, 2019

MRG-110 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2001

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

MRG-110 clinical trials

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
Healthy VolunteerUnlock trial analytics

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?

MRG-110 is an investigational small molecule developed by CASI Pharmaceuticals, Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers in the United States. The specific disease indications for MRG-110 have not been disclosed.

Who is developing MRG-110?

MRG-110 is being developed by CASI Pharmaceuticals, Inc., which trades under the ticker CASI. The company sponsored the Phase 1 study of MRG-110 conducted in the United States.

What phase is MRG-110 in?

MRG-110 is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The study enrolled 42 healthy volunteers and evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics.

What clinical trials is MRG-110 in?

MRG-110 has been evaluated in one completed Phase 1 trial, NCT03603431, titled Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MRG-110 Following Intradermal Injection in Healthy Volunteers. The trial enrolled 42 participants in the United States and was randomized, double-blind, and placebo-controlled.

What did the MRG-110 Phase 1 trial study?

The Phase 1 trial NCT03603431 assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of MRG-110 after intradermal injection in healthy volunteers. It enrolled 42 participants aged 19 years and older, used a randomized, double-blind, placebo-controlled design, and has been completed.