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CG001419

Phase 1

Healthy Volunteer Study | Small molecule | Pain |Pulmatrix, Inc.|Last Updated: Feb 20, 2026

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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment72
FDA Designations
No designations recorded
Clinical trial landscape

CG001419 · 2 trials · 6 indications

Phase 1 2
NCT06636500A Phase 1 Study of CG001419 Administered Orally in Healthy SubjectsHealthy Volunteer Study
COMPLETED72 Analytics
NCT07394374A Phase 1/2 Study of CG001419 Tablets in Adult Subjects With Locally Advanced or Metastatic Solid Tumours Harbouring NTRK Gene AbnormalitiesSolid Tumors Harboring NTRK Fusion
RECRUITING42 Analytics
PHASE1COMPLETED
A Phase 1 Study of CG001419 Administered Orally in Healthy Subjects
Healthy Volunteer Study
NCT0663650072
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PHASE1RECRUITING
A Phase 1/2 Study of CG001419 Tablets in Adult Subjects With Locally Advanced or Metastatic Solid Tumours Harbouring NTRK Gene Abnormalities
Solid Tumors Harboring NTRK Fusion
NCT0739437442
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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)

Phase 1: Maximum Tolerated Dose (MTD)
After the first treatment cycle（each cycle is 28 days）, DLT assessment

Defined as the highest dose level at which no more than 1/6 of the subjects experience dose-limiting toxicity(DLT) during the DLT assessment period.

Phase 1: Recommended Phase 2 Dose (RP2D)
Approximately 3 years

Defined as the optimal Phase II dosing regimen explored and selected based on the comprehensive evaluation of the drug's safety, tolerability, pharmacokinetic profile, and efficacy.

Phase1: Incidence of Adverse Events [Safety and Tolerability]
Approximately 3 years

According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, evaluate the safety and tolerability of CG001419 at different doses in the treatment of advanced solid tumors.

Phase 2: Overall response rate (ORR)
The entire test cycle, approximately 8 years.

The proportion of subjects whose best overall response is Complete Response(CR) or Partial Response(PR) in the study assessed by Independent Central Review(IRC) according to Response Evaluation Criteria in Solid Tumors(RECIST) v1.1.

Secondary Endpoints
To further characterize the PK of CG001419 in healthy subjects
Up to 7 days of dosing
Objective Response Rate (ORR)
The entire test cycle, approximately 8 years.
Disease Control Rate（DCR）
The entire test cycle, approximately 8 years.
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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
200 mg QDEXPERIMENTALCG001419
200 mg BIDEXPERIMENTALCG001419
400 mg QDEXPERIMENTALCG001419
800 mg QDEXPERIMENTALCG001419
600 mg QDEXPERIMENTALCG001419
1200 mg QDEXPERIMENTALCG001419
1600 mg QDEXPERIMENTALCG001419
Interventions
NameTypeDescription
CG001419DRUGOral doses
PlaceboDRUGOral doses
CG001419 tabletsDRUGFor QD administration, a single dose was given each morning. For BID administration, two doses were given 12 hours apart, one in the morning and one in the evening. Treatment Schedule:Repeated dosing was administered in 28-day treatment cycles.
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Eligibility Criteria
Age Range18 Years to 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:AustraliaChina
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07394374studyFirstPostDate: changed