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SRN-001

Phase 1

Idiopathic Pulmonary Fibrosis | Small molecule | Respiratory |cbdMD, Inc.|Last Updated: Nov 4, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

SRN-001 · 1 trial · 1 indication

Phase 1 1
NCT05984992The First-in-human Study of SRN-001 in Healthy ParticipantsIdiopathic Pulmonary Fibrosis
COMPLETED25 Analytics
PHASE1COMPLETED
The First-in-human Study of SRN-001 in Healthy Participants
Idiopathic Pulmonary FibrosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with treatment-emergent adverse events(TEAEs)
Up to 4 weeks
Number of participants with serious adverse events(SAEs)
Up to 4 weeks

Secondary Endpoints

Cmax
Up to 168 hours post-dose
Clast
Up to 168 hours post-dose
Tlast
Up to 168 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SRN-001EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
SRN-001DRUGsiRNA therapeutics, Self Assembled Micelle inhibitory RNA platform utilized
PlaceboDRUG0.9% Sodium Chloride(Normal saline)
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Age 18-70 * BMI ≥18.0 kg/㎡ and ≤35 kg/㎡ * 12-lead triplicate electrocardiogram (ECG) readings within normal limits or with no clinically significant abnormalities * systolic blood pressure ≥ 90 mmHg and ≤160 mmHg; a diastolic blood pressure ≥ 50 mmHg and ≤95 mmHg; pulse ≥ 45 b...

Countries:Australia
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Frequently asked questions about SRN-001

What is SRN-001 used for?

SRN-001 is an investigational small molecule being developed for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a chronic and progressive lung disease. It is currently in clinical development and has not been approved by regulatory authorities.

Who makes SRN-001?

SRN-001 is being developed by cbdMD, Inc., a company publicly traded under the ticker symbol YCBD on the NYSE American exchange. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.

What phase is SRN-001 in?

SRN-001 is in Phase 1 clinical development. A first-in-human study has been completed, and the drug remains investigational. It has not received regulatory approval and is still undergoing clinical evaluation for safety and tolerability.

What clinical trials is SRN-001 in?

SRN-001 has one completed Phase 1 clinical trial, identified as NCT05984992, titled 'The First-in-human Study of SRN-001 in Healthy Participants.' This randomized, double-blind, placebo-controlled study enrolled 25 participants in Australia and included healthy volunteers aged 18 years and older.

Is SRN-001 the same as any other drug?

No alternative names for SRN-001 have been disclosed. It is identified solely by its developmental code name SRN-001 in clinical trial registries and company communications.