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SHR0302

Phase 1

Graft-versus-host Disease | Small molecule | Immunology |Co-Diagnostics, Inc.|Last Updated: Dec 8, 2023

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05856058To Assess SHR0302 Oral Solutions and Tablets in Healthy Subjects Clinical Studies of Relative BioavailabilityPHASE1 COMPLETED 16May 29, 2023Oct 9, 2023Dec 8, 20231 China
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Study Endpoints
Primary Endpoints
SHR0302 and its main Pk parameter, AUC0-t
day 1 to 8
SHR0302 and its main Pk parameter, AUC0-inf
day 1 to 8
SHR0302 and its main Pk parameter, Cmax
day 1 to 8
Relative bioavailability (F%) value between SHR0302 oral solution and SHR0302 tablet: F% = AUC0-t (oral solution) / AUC0-t (tablet) ×100%
day 1 to 8
Secondary Endpoints
SHR0302 and its main Pk parameter, Tmax (SHR0302 only)
day 1 to 8
SHR0302 and its main Pk parameter, t1/2 (SHR0302 only)
day 1 to 8
SHR0302 and its main Pk parameter, CL/F (SHR0302 only)
day 1 to 8
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Treatment group ARM 1EXPERIMENTALSHR0302 tablets, then SHR0302 oral solution
Treatment group ARM 2EXPERIMENTALSHR0302 oral solution, then SHR0302 tablets
Interventions
NameTypeDescription
SHR0302DRUGSHR0302 oral solution 1 time, SHR0302 tablets 1 time
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Eligibility Criteria
Age Range18 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Voluntarily sign the informed consent form before the start of the activities related to the trial, and be able to understand the procedures and methods of the trial, and be willing to strictly abide by the clinical trial protocol to complete the trial; 2. Age 18\~45 years ol...

Countries:China
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