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ND-L02-s0201

Phase 1

Fibrosis | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Aug 7, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

ND-L02-s0201 · 3 trials · 3 indications

Phase 1 3
NCT03241264A Study of Safety, Tolerability, and the Effects Two ND-L02-s0201 Have on the BodyFibrosis
COMPLETED12 Analytics
NCT02227459Phase 1b/2, Open Label, Repeat Dose, Dose Escalation Study of ND-L02-s0201 Injection in Subjects With Moderate to Extensive Fibrosis (METAVIR F3-4)Moderate to Extensive Hepatic Fibrosis (METAVIR F3-4)
COMPLETED25 Analytics
NCT01858935A Phase 1, Randomized, Double-Blind, Placebo-Controlled Escalating Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ND-L02-s0201 Injection in Normal Healthy SubjectsHealthy
COMPLETED56 Analytics
PHASE1COMPLETED
A Study of Safety, Tolerability, and the Effects Two ND-L02-s0201 Have on the Body
Fibrosis
NCT0324126412
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PHASE1COMPLETED
Phase 1b/2, Open Label, Repeat Dose, Dose Escalation Study of ND-L02-s0201 Injection in Subjects With Moderate to Extensive Fibrosis (METAVIR F3-4)
Moderate to Extensive Hepatic Fibrosis (METAVIR F3-4)
NCT0222745925
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PHASE1COMPLETED
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Escalating Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ND-L02-s0201 Injection in Normal Healthy Subjects
Healthy
NCT0185893556
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Study Endpoints

Primary Endpoints

Maximum plasma concentration (Cmax)
Up to 28 days
Time to maximum plasma concentration (Tmax)
Up to 28 days
Area under the plasma concentration-time curve from time 0 to the last available observable concentration (AUC0-t)
Up to 28 days
Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞)
Up to 28 days
Area under the first moment of the plasma concentration-time curve from time zero to infinity (AUMC0-inf)
Up to 28 days
Apparent first-order terminal elimination rate constant (Kel)
Up to 28 days
Volume of distribution during the elimination phase after IV administration (Vz)
Up to 28 days
Apparent volume of distribution at steady-state (Vss)
Up to 28 days
Total plasma clearance of drug after IV administration (CL/F)
Up to 28 days
Apparent first-order terminal elimination half-life (T1/2)
Up to 28 days
Number of participants with serious and non-serious adverse events
After treatment for 5 consecutive weeks and follow-up through week 24
Incidence, nature, and severity of adverse events and abnormal clinical laboratory tests
After single-ascending doses

Secondary Endpoints

Incidence of adverse events (AEs)
Up to 28 days
Incidence of serious adverse events (SAEs)
Up to 28 days
Incidence of discontinuations of study drug due to toxicity
Up to 28 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Module AEXPERIMENTALLyophilized Formulation
Module BEXPERIMENTALFrozen Formulation
Experimental: Arm AEXPERIMENTALOnce a week dosing
Experimental: Arm BEXPERIMENTALTwice a week dosing
ND-L02-s0201 Injection 0.03 mg/kgEXPERIMENTAL -
ND-L02-s0201 Injection 0.1 mg/kgEXPERIMENTAL -
ND-L02-s0201 Injection 0.2 mg/kgEXPERIMENTAL -
ND-L02-s0201 Injection 0.4 mg/kgEXPERIMENTAL -
ND-L02-s0201 Injection 0.5 mg/kgEXPERIMENTAL -
ND-L02-s0201 Injection 0.6 mg/kgEXPERIMENTAL -
ND-L02-s0201 Injection 0.8 mg/kgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
ND-L02-s0201DRUGSpecified dose on specified day
ND-L02-s0201 InjectionDRUG -
PlaceboDRUGSingle IV infusion.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Subject is in good health, as determined by the Investigator * Subject consumes an average of no more than 2 alcoholic drinks per day within the 6 months before administration of study drug * Subject has serum calcium and parathyroid hormone (intact) within the limits of the n...

Countries:United StatesBulgaria
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Competitive Landscape -Cystic Fibrosis 17 trials (matched to "Fibrosis")

CompanyTickerTrialsLead PhaseDrugs
Vertex Pharmaceuticals IncorporatedVRTX8PHASE3VX-121/TEZ/D-IVA
Sionna Therapeutics, Inc.SION2PHASE2SION-719
BiomX Inc.PHGE1PHASE2BX004
4D Molecular Therapeutics, Inc.FDMT1PHASE24D-710
Arcturus Therapeutics Holdings, Inc.ARCT1PHASE2ARCT-032
Krystal Biotech, Inc.KRYS1PHASE1KB407
Illumina, Inc.ILMN1 - Undisclosed
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Frequently asked questions about ND-L02-s0201

What is ND-L02-s0201 used for?

ND-L02-s0201 is an investigational small molecule being studied for the treatment of fibrosis, including moderate to extensive hepatic fibrosis (METAVIR F3-4). It has also been evaluated in healthy subjects. The drug is in Phase 1 clinical development and is not approved by the FDA.

Who makes ND-L02-s0201?

ND-L02-s0201 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The drug is currently in Phase 1 clinical trials for fibrosis and related conditions.

What phase is ND-L02-s0201 in?

ND-L02-s0201 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed for healthy subjects and for patients with moderate to extensive hepatic fibrosis.

What clinical trials is ND-L02-s0201 in?

ND-L02-s0201 has been studied in three completed Phase 1 trials. NCT01858935 evaluated safety and pharmacokinetics in healthy subjects. NCT02227459 assessed repeat dosing in patients with METAVIR F3-4 fibrosis. NCT03241264 examined safety and tolerability in subjects with fibrosis.

Is ND-L02-s0201 the same as any other drug?

No alternative names for ND-L02-s0201 have been reported. The drug is identified solely by its code name ND-L02-s0201 in clinical trial registries and development records.