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Phase 1b Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeated Doses of DB-020 in Patients Receiving Cisplatin

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Trial Profile

Phase 1b Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeated Doses of DB-020 in Patients Receiving Cisplatin

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 10 Jul 2024

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At a glance

  • Drugs Sodium thiosulfate (Primary)
  • Indications Chemotherapy-induced damage; Sensorineural hearing loss
  • Focus Adverse reactions; Proof of concept
  • Sponsors Decibel Therapeutics

Most Recent Events

  • 04 Jun 2024 Results assessing the safety and tolerability of repeated IT injections of DB-020 and compare CP-induced hearing changes with DB-020 vs placebo, presented at the 60th Annual Meeting of the American Society of Clinical Oncology.
  • 11 Aug 2023 According to a Decibel Therapeutics media release, company received FDA Breakthrough Therapy Designation for DB-020, a novel, proprietary formulation of sodium thiosulfate (STS), designed to protect against hearing loss in cancer patients receiving cisplatin chemotherapy.
  • 03 Jul 2023 Status changed from active, no longer recruiting to completed.

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