NCT05193851

Evaluate the Safety and Pharmacokinetics of Ricolinostat

A Phase I Clinical Study Evaluating the Safety and Pharmacokinetics of Ricolinostat in Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Beijing 3E-Regenacy Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is an open-label, phase I clinical study to evaluate the safety and pharmacokinetics of ricolinostat in healthy Chinese adult subjects.

Detailed description

This study is an open-label, phase I clinical study to evaluate the safety and pharmacokinetics of ricolinostat in healthy Chinese adult subjects. 12 subjects are planned to be enrolled, both male and female, and all will receive the investigational drug.

Conditions

• Peripheral Nervous System Diseases

Interventions

Type	Name	Description
DRUG	ricolinostat	This study is an open-label, single-dose phase I clinical study to evaluate the safety and pharmacokinetics of ricolinostat in healthy Chinese adult subjects. 12 subjects are planned to be enrolled, both male and female, and all will receive the investigational drug. This study includes the screening period, baseline period, dosing/observation period, discharge and follow-up period.

Timeline

• Start date: 2022-01-12
• Primary completion: 2022-01-30
• Completion: 2023-01-06
• First posted: 2022-01-18
• Last updated: 2023-04-03

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study