Clinical trial NCT05193851: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Peripheral Nervous System Diseases
Lead sponsor: Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-01-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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;

Primary outcomes:
measure: safety of dosed subjects
timeFrame: about one week
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: Bethune First Hospital Of Jilin University
Study officials:
affiliation: China
name: Xiaojiao Li
role: PRINCIPAL_INVESTIGATOR
References: