Recent Updates
Recently added Catalysts

ND-L02-s0201

Phase 1

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

ND-L02-s0201 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2017

ND-L02-s0201 target and mechanism

ModalitySmall molecule

Also known as ND-L02-s0201 Injection

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment37

FDA Designations

No designations recorded

ND-L02-s0201 clinical trials

ND-L02-s0201 · 2 trials · 2 indications

Phase 1 2
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
PHASE1COMPLETED
A Study of Safety, Tolerability, and the Effects Two ND-L02-s0201 Have on the Body
FibrosisUnlock trial analytics
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)Unlock trial analytics

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

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
Unlock Study Endpoints

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

Interventions

NameTypeDescription
ND-L02-s0201DRUGSpecified dose on specified day
ND-L02-s0201 InjectionDRUG -
Unlock Study Design Details

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
Unlock Eligibility Criteria

Competitive Landscape -Cystic Fibrosis 20 trials (matched to "Fibrosis")

Frequently asked questions about ND-L02-s0201

What is ND-L02-s0201?

ND-L02-s0201 is an investigational small molecule developed by Bristol-Myers Squibb Company (ticker BMY). It has been studied in clinical trials for fibrosis, including moderate to extensive hepatic fibrosis classified as METAVIR F3-4. It is not an approved therapy and remains in clinical development.

What is ND-L02-s0201 used for?

ND-L02-s0201 has been studied for the treatment of fibrosis, specifically moderate to extensive hepatic fibrosis scored as METAVIR F3-4. The clinical program evaluated its safety, tolerability, and effects in the body. It is investigational and has not been established as a treatment for any condition.

Who makes ND-L02-s0201?

ND-L02-s0201 is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company sponsored the clinical studies of the asset, including a Phase 1 study in healthy volunteers and a Phase 1b/2 study in patients with moderate to extensive hepatic fibrosis.

What phase is ND-L02-s0201 in?

ND-L02-s0201 is in Phase 1 development. Its clinical program includes a completed Phase 1 study and a completed Phase 1b/2 study. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is ND-L02-s0201 in?

ND-L02-s0201 has been evaluated in two completed trials: NCT03241264, a Phase 1 study of safety, tolerability, and effects on the body in 12 healthy volunteers, and NCT02227459, a Phase 1b/2 open label, repeat dose, dose escalation study in 25 subjects with moderate to extensive hepatic fibrosis (METAVIR F3-4) conducted in the United States and Bulgaria.

Is ND-L02-s0201 the same as ND-L02-s0201 Injection?

Yes. ND-L02-s0201 Injection is another name for ND-L02-s0201. The trial listing for NCT02227459 refers to the asset as ND-L02-s0201 Injection, while other study records use the shorter name ND-L02-s0201. Both refer to the same investigational small molecule developed by Bristol-Myers Squibb.