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DB-020

Phase 1

Ototoxicity | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Jul 6, 2023

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

Clinical trial landscape

DB-020 · 1 trial · 1 indication

Phase 1 1
NCT04262336Study to Evaluate Safety and Efficacy of DB-020 to Protect Hearing in Patients Receiving Cisplatin for Cancer TreatmentOtotoxicity
COMPLETED22 Analytics
PHASE1COMPLETED
Study to Evaluate Safety and Efficacy of DB-020 to Protect Hearing in Patients Receiving Cisplatin for Cancer Treatment
OtotoxicityUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of patients with treatment-emergent Adverse Events (TEAEs) and/or abnormal changes from baseline in clinical laboratory abnormalities and/or vital signs and/or ECG assessments
From screening/baseline (Day -28 to Day -2) or day of first dose of DB-020 (Cycle 1 Day 1) for up to 6 cycles (21 or 28 day cycles) through End of Treatment Visit (28 days after last dose of study drug), up to 196 Days after first dose of study drug

To investigate the safety and tolerability of DB-020 when given intratympanically to patients receiving cisplatin chemotherapy treatment

Secondary Endpoints

Incidence of Ototoxicity measured by American Speech-Language-Hearing Association (ASHA) criteria
Baseline (Day -5 to Day -1) for up to 6 cycles (21 or 28 day cycles) through End of Treatment Visit (28 days after last dose of study drug), up to 196 Days after first dose of study drug
Changes from Baseline in Pure Tone Threshold Values compared to End of Treatment [Changes in Hearing]
Baseline (Day -5 to Day -1) for up to 6 cycles (21 or 28 day cycles) through End of Treatment Visit (28 days after last dose of study drug), up to 196 Days after first dose of study drug
Changes from Baseline in Tinnitus Functional Index (TFI) Total Score compared to End of Treatment [Changes in Hearing]
Baseline (Day -5 to Day -1) for up to 6 cycles (21 or 28 day cycles) through End of Treatment Visit (28 days after last dose of study drug), up to 196 Days after first dose of study drug
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
DB-020 for Injection, 12%/placeboACTIVE_COMPARATORdosage
DB-020 for Injection, 25%/placeboACTIVE_COMPARATORdosage

Interventions

NameTypeDescription
DB-020DRUGInjectable sterile viscous solution of DB-020 and sodium hyaluronate in sterile water
PlaceboDRUGInjectable sterile viscous solution of sodium hyaluronate in sodium chloride
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Ability to communicate with medical team and staff, willingness to participate in the study, give written informed consent, comply with the study restrictions * Adults aged 18 years, inclusive, or older * Treatment for cancer with Intervenous cisplatin once every 21 or 28 days...

Countries:United StatesAustralia
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Frequently asked questions about DB-020

What is DB-020 used for?

DB-020 is an investigational small molecule being developed to protect hearing in patients receiving cisplatin for cancer treatment. It is intended to address ototoxicity, which is hearing damage caused by cisplatin chemotherapy. The drug is currently in Phase 1 clinical development.

Who is developing DB-020?

DB-020 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN. The company is conducting clinical research to evaluate the safety and efficacy of DB-020 in protecting hearing in patients undergoing cisplatin-based cancer treatment.

What phase is DB-020 in?

DB-020 is in Phase 1 clinical development. A Phase 1 clinical trial has been completed to evaluate the safety and efficacy of DB-020 in protecting hearing in patients receiving cisplatin for cancer treatment. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials has DB-020 been in?

DB-020 has been studied in one completed Phase 1 clinical trial, identified as NCT04262336. This trial evaluated the safety and efficacy of DB-020 to protect hearing in patients receiving cisplatin for cancer treatment. The study enrolled 22 participants and was conducted in the United States and Australia.

Is DB-020 the same as any other drug?

DB-020 is the primary name used for this investigational drug in clinical research. No alternative names have been reported in the context of its development by Regeneron Pharmaceuticals. The drug is being studied specifically for its potential to prevent cisplatin-induced hearing loss.