Evaluate the Safety and Pharmacokinetics of Ricolinostat

Peripheral Nervous System Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05193851
• Other study ID #: BCRG-CN-102
• Status: Completed
• Phase: Phase 1
• Start date: January 12, 2022
• Est. completion date: January 6, 2023

Study information

• Verified date: December 2021
• Source: Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 6, 2023
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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;

Related Conditions & MeSH terms

• Nervous System Diseases
• Peripheral Nervous System Diseases

Intervention

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.

Locations

Country	Name	City	State
China	Bethune First Hospital Of Jilin University	Changchun

Sponsors (1)

Lead Sponsor	Collaborator
Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety of dosed subjects	monitor AEs	about one week