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Lisofylline

Phase 1

Healthy | Small molecule | Metabolic |cbdMD, Inc.|Last Updated: Jul 29, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

Lisofylline · 1 trial · 2 indications

Phase 1 1
NCT00896077Subcutaneous Administration of Lisofylline to Healthy Normal Subjects and Subjects With Type 1 DiabetesHealthy
COMPLETED8 Analytics
PHASE1COMPLETED
Subcutaneous Administration of Lisofylline to Healthy Normal Subjects and Subjects With Type 1 Diabetes
Healthy
NCT008960778
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Study Endpoints

Primary Endpoints

Safety (based on AEs, vital signs assessments, resting 12-lead ECG evaluations, physical examination findings and clinical laboratory test results)
LSF Plasma levels: D1-2, 7-8; T 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24 h; D2, 8; T 5, 10, 15, 30 min and 1, 2, 3, 4, 6, 8, 10, 12, 16 h post inf. Cytokine, chemokine, insulin, free fatty acid STAT4 phosphorylation in monocytes: D1-2, 7-8

Secondary Endpoints

Pharmacokinetic (PK) parameters will include AUC0-t, AUC0-inf, Cmax, Tmax, t1/2, kel, CL, Vdss and F
LSF Plasma levels: D1-2, 7-8; T 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24 h; D2, 8; T 5, 10, 15, 30 min and 1, 2, 3, 4, 6, 8, 10, 12, 16 h post inf. Cytokine, chemokine, insulin, free fatty acid STAT4 phosphorylation in monocytes: D1-2, 7-8
Pharmacodynamic (PD) assessments (blood will be collected for determination of serum cytokine, chemokine, insulin and FFA levels at time points noted previously)
LSF Plasma levels: D1-2, 7-8; T 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24 h; D2, 8; T 5, 10, 15, 30 min and 1, 2, 3, 4, 6, 8, 10, 12, 16 h post inf. Cytokine, chemokine, insulin, free fatty acid STAT4 phosphorylation in monocytes: D1-2, 7-8
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
SubcutaneousACTIVE_COMPARATORSubcutaneous administration of LSF
IVACTIVE_COMPARATORIV administration arm

Interventions

NameTypeDescription
LisofyllineDRUGLisofylline via i.v. administration vs Lisofylline vs s.c. administration
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects who meet all of the following criteria are eligible for participation in the healthy subject cohort of the study: 1. Ability to understand and provide written informed consent; 2. Ability to complete the study in compliance with the protocol; 3. Healthy male or...

Countries:United States
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Frequently asked questions about Lisofylline

What is Lisofylline?

Lisofylline is a small molecule being developed by cbdMD, Inc. (YCBD) as a potential treatment for metabolic conditions. It is currently in Phase 1 clinical development. The drug has been studied in a completed Phase 1 trial involving healthy subjects and individuals with Type 1 diabetes.

What is Lisofylline used for?

Lisofylline is being investigated for use in metabolic conditions, specifically studied in the context of Type 1 diabetes. A completed Phase 1 trial evaluated subcutaneous administration of Lisofylline in healthy normal subjects and subjects with Type 1 diabetes.

Who makes Lisofylline?

Lisofylline is being developed by cbdMD, Inc., a company traded under the ticker symbol YCBD. The company is conducting clinical research on this small molecule for metabolic indications.

What phase is Lisofylline in?

Lisofylline is in Phase 1 clinical development. It has completed one Phase 1 trial, which was a randomized, active-controlled study with 8 participants. The trial is no longer active, and no ongoing trials are currently listed for this drug.

What clinical trials is Lisofylline in?

Lisofylline has been studied in one completed clinical trial, identified as NCT00896077. This Phase 1 trial examined subcutaneous administration of Lisofylline in healthy subjects and individuals with Type 1 diabetes. The trial was conducted in the United States and enrolled 8 participants.