Evaluate the Safety and Pharmacokinetics of Ricolinostat

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

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

Study Overview

• Status: Completed
• Conditions: Peripheral Nervous System Diseases
• Intervention / Treatment: Drug: ricolinostat

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Changchun, China
    • Bethune First Hospital Of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Only patients who meet all of the following inclusion criteria can be enrolled in this study:

  1. Healthy adult male or female subjects aged 18 to 55 years;
  2. Body mass index of 19 - 26 kg/m2 (including the boundary value); the weight of male subjects should not be lower than 50 kg, and the weight of female subjects should not be lower than 45 kg;
  3. Subjects have no pregnancy plan and voluntarily take effective contraceptive measures during the study to 3 months after the last dose and have no sperm or egg donation plan.
  4. Subjects who fully understand the objective, nature, method and possible adverse reactions of the study, volunteer to be subjects and sign the informed consent form;
  5. Able to complete the study according to the protocol requirements.

Exclusion Criteria:

• Subjects who meet any of the following exclusion criteria are excluded:

  1. Allergic to ricolinostat (including excipients) and other similar drugs;
  2. Have had a history of drug abuse in the past five years or have used drugs three months before screening, or who have positive result for drug abuse screening at screening;
  3. Smokers (people who smoked tobacco products in the past 3 months), or habitual use of nicotine-containing products, or those who are tested positive for nicotine at screening;
  4. Drinking more than 14 units of alcohol per week within 6 months before screening (1 unit of alcohol = 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) or have taken alcoholic products 48 hours before dosing, or tested positive for alcohol breath test;
  5. Diseases or factors judged by the investigator to be abnormal and clinically significant, including but not limited to neurological, mental, cardiovascular, blood, liver, kidney, gastrointestinal, respiratory, metabolic, endocrine, immune, skeletal system diseases or other factors;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: healthy subjects; 12 healthy Chinese adult subjects, both male and female, are treated with ricolinostat

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety of dosed subjects	monitor AEs	about one week

Collaborators and Investigators

• Sponsor: Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.
• Investigators: Principal Investigator: Xiaojiao Li, China

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Actual): January 30, 2022
• Study Completion (Actual): January 6, 2023

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neuromuscular Diseases; Peripheral Nervous System Diseases; Nervous System Diseases; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Histone Deacetylase Inhibitors; Ricolinostat
• Other Study ID Numbers: BCRG-CN-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No