Evaluate the Safety and Pharmacokinetics of Ricolinostat

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05193851

Enrollment

Registered

2022-01-18

Start date

2022-01-12

Completion date

2023-01-06

Last updated

2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Nervous System Diseases

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.

Interventions

DRUGricolinostat

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026