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HRS-2129

Phase 1

Pain | Small molecule | Pain |Co-Diagnostics, Inc.|Last Updated: Mar 5, 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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment44
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06619392A Single Dose Escalation Trial of HRS-2129 in Healthy SubjectsPHASE1 COMPLETED 44 — — Oct 17, 2024Jan 20, 2025Mar 5, 20251 China
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Study Endpoints
Primary Endpoints
The incidence and severity of adverse events
from ICF signing date to day 28 since last dose
Secondary Endpoints
Pharmacokinetic parameter of HRS-2129: Cmax
0 hour to 216 hour after administration
Pharmacokinetic parameter of HRS-2129: AUC0-t
0 hour to 216 hour after administration
Pharmacokinetic parameter of HRS-2129: AUC0-inf
0 hour to 216 hour after administration
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment at dose level 1EXPERIMENTAL -
Treatment at dose level 2EXPERIMENTAL -
Treatment at dose level 3EXPERIMENTAL -
Treatment at dose level 4EXPERIMENTAL -
Treatment at dose level 5EXPERIMENTAL -
Interventions
NameTypeDescription
HRS-2129DRUGHRS-2129
HRS-2129 PlaceboDRUGHRS-2129 Placebo
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18 to 55 years old (inclusive); 2. Body weight: ≥ 50 kg for male and ≥ 45 kg for female, body mass index: 19.0 \~ 28.0 kg/m2 (inclusive); 3. Subject has no plan to give a birth, donate sperm or eggs from signing the informed consent form to 6 months after last dose; 4. F...

Countries:China
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