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DB-020 · 1 trial · 1 indication
To investigate the safety and tolerability of DB-020 when given intratympanically to patients receiving cisplatin chemotherapy treatment
| Arm | Type | Description |
|---|---|---|
| DB-020 for Injection, 12%/placebo | ACTIVE_COMPARATOR | dosage |
| DB-020 for Injection, 25%/placebo | ACTIVE_COMPARATOR | dosage |
| Name | Type | Description |
|---|---|---|
| DB-020 | DRUG | Injectable sterile viscous solution of DB-020 and sodium hyaluronate in sterile water |
| Placebo | DRUG | Injectable sterile viscous solution of sodium hyaluronate in sodium chloride |
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...
DB-020 is being developed to protect hearing in patients who are receiving cisplatin for cancer treatment, a condition known as ototoxicity. It is a small molecule therapeutic candidate studied specifically in adults undergoing cisplatin chemotherapy, with the goal of reducing hearing damage associated with that treatment.
DB-020 is being developed by Regeneron Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker REGN. Regeneron is the sponsor of the clinical program evaluating DB-020 for the prevention of hearing loss in patients treated with cisplatin.
DB-020 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program has completed one trial, and no trials are currently active.
DB-020 has been evaluated in the Phase 1 trial NCT04262336, titled "Study to Evaluate Safety and Efficacy of DB-020 to Protect Hearing in Patients Receiving Cisplatin for Cancer Treatment." The trial enrolled 22 participants across the United States and Australia and has been completed.
The Phase 1 trial NCT04262336 was a randomized, double-blind study with an active control arm. It enrolled 22 adults aged 18 years and older, included both sexes, and did not use healthy volunteers. Participants were patients receiving cisplatin for cancer treatment.