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HSK39004

Phase 1

Healthy Volunteers | Small molecule | Other |Co-Diagnostics, Inc.|Last Updated: May 14, 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
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06971198Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HSK39004 Dry Powder InhalationPHASE1 COMPLETED 26 — — Feb 10, 2025May 6, 2025May 14, 20251 China
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Study Endpoints
Primary Endpoints
adverse events
From the enrollment of the subjects to 72 hours after the last administration
Secondary Endpoints
AUC
from 0 to 72 hours after administration
Cmax
from 0 to 72 hours after administration
t1/2
from 0 to 72 hours after administration
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
HSK39004EXPERIMENTAL -
PlaceboPLACEBO_COMPARATORPlacebo group
Interventions
NameTypeDescription
HSK39004DRUG0.75\~4mg
PlaceboDRUG0.75\~4mg
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Voluntarily sign the informed consent form, understand the trialprocedures, and be willing to comply with all trial procedures andrestrictions; 2. 18 years to 45 years (inclusive), male and female; 3. Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Body mass in...

Countries:China
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