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SHR-4658 .

Phase 1

Heart Failure | Small molecule | Cardiovascular |Co-Diagnostics, Inc.|Last Updated: Nov 17, 2025

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_CONTROLLED
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07230145A Trial of SHR-4658 in Healthy Volunteers or Volunteers With Elevated Blood PressurePHASE1 NOT YET_RECRUITING 48Nov 1, 2025Jul 1, 2026Nov 17, 20251 China
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Study Endpoints
Primary Endpoints
Adverse events (AEs)
Approximately 16 weeks.
Secondary Endpoints
Area under the concentration-time curve from time 0 to the last time point (AUC0-last)
Approximately 16 weeks.
Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Approximately 16 weeks.
Maximum observed concentration (Cmax)
Approximately 16 weeks.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SHR-4658 GroupEXPERIMENTAL -
SHR-4658 Placebo GroupPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
SHR-4658 Injection.DRUGSHR-4658 injection.
SHR-4658 Placebo InjectionDRUGSHR-4658 placebo injection.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Able and willing to provide a written informed consent. 2. Blood pressure as defined in the protocol. 3. Male or female,aged 18 to 55 years (inclusive). 4. Meet the weight standard. Exclusion Criteria: 1. Known history or current clinically significant disease. 2. Protocol-...

Countries:China
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