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CG001419

Phase 1

Healthy Volunteer Study | Small molecule | Pain |Pulmatrix, Inc.|Last Updated: Feb 20, 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 Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06636500A Phase 1 Study of CG001419 Administered Orally in Healthy SubjectsPHASE1 COMPLETED 72 — — Jan 22, 2025Dec 5, 2025Feb 20, 20261 Australia
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Study Endpoints
Primary Endpoints
To evaluate the safety and tolerability of single and multiple ascending oral doses of CG001419 in healthy subjects
Up to 7 days of dosing

Safety and tolerability based on adverse events (AEs)

Secondary Endpoints
To further characterize the PK of CG001419 in healthy subjects
Up to 7 days of dosing
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
CG001419EXPERIMENTALPart A: Single ascending dose cohorts; food effect cohort; Part B: Multiple ascending dose cohorts
PlaceboPLACEBO_COMPARATORPart A: Single ascending dose cohorts; Part B: Multiple ascending dose cohorts
Interventions
NameTypeDescription
CG001419DRUGOral doses
PlaceboDRUGOral doses
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Cis-male and cis-female subjects must be 18-65 years, inclusive, at the time of signing the informed consent form (ICF). * Subjects who are in good general health according to the judgment of the investigator per local guidance, eg, with no clinically relevant abnormalities ba...

Countries:Australia
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