Recent Updates
Recently added Catalysts

MRG-201

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02603224Safety, Tolerability and Pharmacokinetic Study of MRG-201 in Healthy VolunteersPHASE1 COMPLETED 54Nov 1, 2015Apr 1, 2017Jul 6, 20171 Canada
Unlock Drug Trial Details
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
Unlock Study Endpoints
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.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 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
Unlock Eligibility Criteria