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NOV-205

Phase 2

Hepatitis C | Small molecule | Infectious Disease |Cellectar Biosciences, Inc.|Last Updated: Jul 25, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

NOV-205 · 2 trials · 1 indication

Phase 2 1Phase 1 1
NCT01058512A Trial of NOV-205 in Hepatitis C Patients Who Failed Standard TherapyHepatitis C
COMPLETED22 Analytics
PHASE2COMPLETED
A Trial of NOV-205 in Hepatitis C Patients Who Failed Standard Therapy
Hepatitis CUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate changes in viral load
16 months
To evaluate changes in serum ALT and AST levels
16 months
To evaluate the durability of any changes in viral load and serum ALT and AST
16 months
To establish the safety profile of NOV-205
16 months
To evaluate the pharmacokinetic profile of different dosing regimens of NOV-205.
To establish the safety profile of NOV-205 in comparison to that of placebo.
To compare changes in viral load after treatment with NOV-205 or placebo (as evidenced by a quantitative reduction of >0.5 log10 in serum HCV RNA levels by quantitative analysis as compared to the average of the screening and baseline values).
To evaluate the impact of NOV-205 on serum ALT and AST levels in comparison to that of placebo.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SingleEXPERIMENTALsingle-arm study

Interventions

NameTypeDescription
NOV-205DRUGThere will be 4 treatment Groups with 10 patients in each group: * Group A: 30 mg NOV-205 daily subcutaneous administration for 49 days * Group B: 30 mg NOV-205 daily subcutaneous administration for 98 days * Group C: 60 mg NOV-205 daily subcutaneous administration for 49 days * Group D: 60 mg NOV-205 daily subcutaneous administration for 98 days
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * A serum HCV RNA level of \>100,000 IU/ml using a quantitative, branched-chain-DNA (bDNA)-based assay (lower limit of quantitation = \~650 IU/ml) or other equally sensitive quantitative methods. * Infection with genotype 1 HCV * Documented failure to respond to treatment (defin...

Countries:United States
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Competitive Landscape -Hepatitis C 11 trials

Frequently asked questions about NOV-205

What is NOV-205 used for?

NOV-205 is an investigational small molecule being developed for the treatment of Hepatitis C. It is intended for patients who have failed standard therapy. The drug is currently in clinical development and has not been approved by regulatory authorities.

Who makes NOV-205?

NOV-205 is being developed by Cellectar Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CLRB. The company is conducting clinical trials to evaluate the safety and efficacy of NOV-205 in patients with Hepatitis C.

What phase is NOV-205 in?

NOV-205 is in Phase 2 clinical development. It has completed a Phase 1 study and a Phase 2 study, both in patients with Hepatitis C who failed standard therapy. The drug remains investigational and is not yet approved for commercial use.

What clinical trials is NOV-205 in?

NOV-205 has been studied in two completed clinical trials. NCT00372983 was a Phase 1 safety and pharmacokinetics study in 30 patients with chronic Hepatitis C who failed standard therapy. NCT01058512 was a Phase 2 trial in 22 Hepatitis C patients in the United States who failed standard therapy.

Is NOV-205 the same as other drugs?

NOV-205 is the primary name for this investigational drug. No alternative names have been reported for this asset. It is a small molecule being evaluated specifically for Hepatitis C, distinct from other antiviral agents in the same therapeutic area.