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HRS-7535

Phase 1

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Co-Diagnostics, Inc.|Last Updated: Apr 29, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06422039Bioavailability and Food Effects of HRS-7535 Tablets With Different Formulating Processes in Healthy SubjectsPHASE1 COMPLETED 24 — — May 23, 2024Aug 6, 2024Apr 29, 20261 China
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Study Endpoints
Primary Endpoints
PK parameters：Cmax
0 hour to 72 hours after the last dosing
PK parameters：AUC0-t
0 hour to 72 hours after the last dosing
PK parameters：AUC0-∞
0 hour to 72 hours after the last dosing
Relative bioavailability of HRS-7535 (D) tablets compared to HRS-7535 (C) tablets following a high-fat meal
0 hour to 72 hours after the last dosing
Relative bioavailability of HRS-7535 (D) tablets under both fasting and fed (high fat meal) status
0 hour to 72 hours after the last dosing
Secondary Endpoints
PK parameters：Tmax
0 hour to 72 hours after the last dosing
PK parameters： t1/2
0 hour to 72 hours after the last dosing
PK parameters： CL/F
0 hour to 72 hours after the last dosing
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment group AEXPERIMENTAL -
Treatment group BEXPERIMENTAL -
Treatment group CEXPERIMENTAL -
Interventions
NameTypeDescription
HRS-7535(D) TabletsDRUGOne HRS-7535(D) Tablet is administered to healthy subjects.
HRS-7535(C) TabletsDRUGTwo HRS-7535(C) Tablets is administered to healthy subjects.
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Able and willing to provide a written informed consent; 2. Male or female aged 18-45 at screening (both inclusive); 3. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI) : 18-30 kg/m2 (including both ends of the value); 4. Subjects (including male subjects)...

Countries:China
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