Evaluate the Safety and Pharmacokinetics of Ricolinostat

NCT05193851 | Completed Phase 1 FDA Drug

• 1 other identifier: BCRG-CN-102
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peripheral Nervous System Diseases

Outcome Measures

Primary Outcomes (1)

• safety of dosed subjects

  monitor AEs

  about one week

Study Arms (1)

healthy subjects

EXPERIMENTAL

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

Drug: ricolinostat

Interventions

ricolinostat DRUG

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.

healthy subjects

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male or female subjects aged 18 to 55 years;
• 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;
• 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.
• 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;
• Able to complete the study according to the protocol requirements.

You may not qualify if:

• Allergic to ricolinostat (including excipients) and other similar drugs;
• 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;
• 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;
• 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;
• 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;

Sponsors & Collaborators

• Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Bethune First Hospital Of Jilin University

Changchun, China

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

ricolinostat

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Xiaojiao Li

  China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: January 18, 2022
• Study Start: January 12, 2022
• Primary Completion: January 30, 2022
• Study Completion: January 6, 2023
• Last Updated: April 3, 2023

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)