Back to resultsEvaluate the Safety and Pharmacokinetics of Ricolinostat
Primary Purpose
Peripheral Nervous System Diseases
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ricolinostat
Sponsored by
About this trial
This is an interventional other trial for Peripheral Nervous System Diseases
Eligibility Criteria
Inclusion Criteria:
Only patients who meet all of the following inclusion criteria can be enrolled in this study:
- 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.
Exclusion Criteria:
Subjects who meet any of the following exclusion criteria are excluded:
- 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;
Sites / Locations
- Bethune First Hospital Of Jilin University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
healthy subjects
Arm Description
12 healthy Chinese adult subjects, both male and female, are treated with ricolinostat
Outcomes
Primary Outcome Measures
safety of dosed subjects
monitor AEs
Secondary Outcome Measures
Full Information
NCT ID
NCT05193851
First Posted
December 8, 2021
Last Updated
March 30, 2023
Sponsor
Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05193851
Brief Title
Evaluate the Safety and Pharmacokinetics of Ricolinostat
Official Title
A Phase I Clinical Study Evaluating the Safety and Pharmacokinetics of Ricolinostat in Chinese Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 12, 2022 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
January 6, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Nervous System Diseases
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
healthy subjects
Arm Type
Experimental
Arm Description
12 healthy Chinese adult subjects, both male and female, are treated with ricolinostat
Intervention Type
Drug
Intervention Name(s)
ricolinostat
Intervention Description
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.
Primary Outcome Measure Information:
Title
safety of dosed subjects
Description
monitor AEs
Time Frame
about one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Only patients who meet all of the following inclusion criteria can be enrolled in this study:
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.
Exclusion Criteria:
Subjects who meet any of the following exclusion criteria are excluded:
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaojiao Li
Organizational Affiliation
China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bethune First Hospital Of Jilin University
City
Changchun
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluate the Safety and Pharmacokinetics of Ricolinostat
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