NCT05229042

A Study to Investigate the Safety and Efficacy of Ricolinostat

An Exploratory Study to Investigate the Safety and Efficacy of Ricolinostat for Chemotherapy-Induced Peripheral Neuropathy (CIPN)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Beijing 3E-Regenacy Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blind, placebo-controlled study during which patients will receive ricolinostat or placebo.

Detailed description

This is a double-blind, placebo-controlled study during which patients will receive ricolinostat or placebo. Prior to randomization, patients will participate in the Screening and Baseline assessment period to ensure that they meet study inclusion/exclusion criteria. Following the Screening and Baseline assessment period, patients who meet entry criteria will be randomized in a 2:1 ratio to receive either ricolinostat or placebo.

Conditions

• Peripheral Nervous System Diseases

Interventions

Type	Name	Description
DRUG	Ricolinostat	Oral

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-11-10
• Completion: 2023-11-10
• First posted: 2022-02-08
• Last updated: 2023-12-04

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study