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SHR-4597

Phase 1

Healthy Subjects | Small molecule | Respiratory |Co-Diagnostics, Inc.|Last Updated: Mar 6, 2026

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 Enrollment62
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06385964A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-4597 Inhalation in Healthy Subjects and Asthmatic PatientsPHASE1 COMPLETED 62May 7, 2024Feb 19, 2025Mar 6, 20261 China
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Study Endpoints
Primary Endpoints
Incidence and severity of inhalant adverse events after 4 days of single inhalation of SHR4597 in healthy subjects
4 days for healthy subjects
Incidence and severity of inhalant adverse events after 16 days of multiple inhalation of SHR4597 in asthmatic patients,
16 days for asthmatic patients.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SHR-4597EXPERIMENTAL -
SHR-4597 PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
SHR-4597DRUGSHR-4597 by dry powder inhalation
PlaceboDRUGPlacebo by dry powder inhalation
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: \- Healthy subjects: * Understand the specific procedures of the trial, voluntarily participate in this trial, and sign the informed consent form in writing. * Aged between 18 and 55 years old (inclusive of boundary values). * Male subjects with a weight of ≥ 50 kg and female ...

Countries:China
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