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CompletedNCT05193851Updated Apr 3, 2023

Evaluate the Safety and Pharmacokinetics of Ricolinostat

A Phase 1 interventional study of ricolinostat in Peripheral Nervous System Diseases, sponsored by Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-03.

Sponsored by Beijing 3E-Regenacy Pharmaceuticals Co., Ltd. · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Jan 2022, 4 years 8 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Peripheral Nervous System Diseases
03

In context

Peripheral Nervous System Diseases

1,006 studies on the registry are indexed under Peripheral Nervous System Diseases; 179 are open to participants now.

This study's enrollment of 12 is below the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.

Browse Peripheral Nervous System Diseases studies →

Lead sponsor

Beijing 3E-Regenacy Pharmaceuticals Co., Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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;
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    healthy subjects

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

    Drug: ricolinostat

Interventions

  • 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.

06

What researchers measure

Primary outcomes

  1. safety of dosed subjects

    monitor AEs

    Time frame: about one week

07

Study locations

1 site
  • Bethune First Hospital Of Jilin University
    Changchun, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2022 to primary completion in Jan 2022, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 8, 2021
First posted
Jan 18, 2022
StartActual
Jan 12, 2022
Primary completionActual
Jan 30, 2022
CompletionActual
Jan 6, 2023
Last update
Apr 3, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05193851
Lead sponsor
Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
Jan 18, 2022
Start date
Jan 12, 2022
Primary completion
Jan 30, 2022
Completion
Jan 6, 2023
Last update
Apr 3, 2023

Study contacts

Xiaojiao Li
principal investigator · China

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Ricolinostat

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