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MRG-110

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03603431Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MRG-110 Following Intradermal Injection in Healthy VolunteersPHASE1 COMPLETED 42Apr 9, 2018Mar 13, 2019May 7, 20191 United States
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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 — 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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