A Study of CL-197 Capsules in Healthy Participants

April 23, 2024 updated by: HeNan Sincere Biotech Co., Ltd

A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of CL-197 Capsules Administered in Single Dose in Healthy Participants

The goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetic characteristics of CL-197 capsules in health conditions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this trial, 46 healthy participants will be enrolled, 6 healthy participants in 1mg group, 40 healthy participants distributed equally in other four groups: 10mg group, 30mg group, 60mg group and 100mg group, including thier respective placebo control groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • The Fifth Medical Center of Chinese PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy adult subjects, aged 18~45 (including boundary values), both male and female;
  2. Body mass index (BMI) should be in the range of 19.0-26.0 (including the boundary value) (BMI = weight (kg) / height 2 (m2)), the body weight of male subjects should be ≥ 50.0kg, and the body weight of female subjects should be ≥ 45.0kg;
  3. Those who have no family plan within 2 weeks before screening and within 3 months after the end of the trial and agree to use effective non-pharmacological contraception during the trial;
  4. Understand and sign the informed consent form voluntarily.

Exclusion Criteria:

  1. Allergic constitution, with a history of drug or food allergies, especially allergic to any ingredient in this product and excipients;
  2. Those with a history of hypoglycemia in the past;
  3. Pre-test medical history, physical examination, laboratory items and test-related examinations and abnormal tests have clinical significance, and the clinical research doctor judges to be unqualified;
  4. Those with a history of smoking in the 12 months before screening (the number of cigarettes per day≥ 5);
  5. Those who have a history of alcoholism in the 12 months before screening (drink ≥ 14 units of alcohol per week: 1 unit = 285mL of beer, or 25mL of spirits, or 150mL of wine) or positive alcohol breath test (test value>0mg/100mL) before enrollment;
  6. Those who have a history of drug abuse within 12 months before screening or who have tested positive for addictive substances before enrollment;
  7. Those who have undergone surgery within 3 months before screening, especially those who have undergone surgery that will affect drug absorption, distribution, metabolism, and excretion, or those who plan to undergo surgery during the study;
  8. Any drugs that interact with investigational drugs, such as potent CYP3A inhibitors (such as clarithromycin, indinavir, itraconazole, etc.), have been used within 30 days before screening;
  9. Have a previous history of cardiovascular, hepatic, renal, lung, digestive tract, nerve and other diseases, especially any surgical condition or condition that may affect the absorption, distribution, metabolism and excretion of drugs, or any surgical condition or condition that may pose a hazard to the subjects participating in the trial;
  10. Those who have a febrile illness within 3 days before screening;
  11. Those who have participated in other clinical trials within 3 months before screening;
  12. Those who have a history of taking any prescription drugs, over-the-counter drugs, Chinese herbal medicines, and health products within 14 days before screening;
  13. Those who consumed excessive tea, coffee and/or beverages rich in caffeine, xanthine and alcohol (more than 8 cups, 1 cup = 250mL) every day within 3 months before screening;
  14. Those who have lost blood or donated blood ≥ 200mL within 8 weeks before screening;
  15. Pregnant and lactating women;
  16. Those who cannot tolerate venipuncture blood collection and/or have a history of blood sickness and needle sickness;
  17. Those who have been vaccinated against the new coronavirus within 1 week before screening, or those who have received other vaccines within 3 months before screening;
  18. Those who are not considered suitable to enter this test by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1mg group
Single oral dose of 1 mg CL-197 capsules or CL-197 placebo
Drug: 1 mg CL-197 capsules
Single oral dose of 1 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast
Experimental: 10mg group
Single oral dose of 10 mg CL-197 capsules or CL-197 placebo
Drug: 10 mg CL-197 capsules or CL-197 placebo
Single oral dose of 10 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast
Experimental: 30mg group
Single oral dose of 30 mg CL-197 capsules or CL-197 placebo
Drug: 30 mg CL-197 capsules or CL-197 placebo
Single oral dose of 30 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast
Experimental: 60mg group
Single oral dose of 60 mg CL-197 capsules or CL-197 placebo
Drug: 60 mg CL-197 capsules or CL-197 placebo
Single oral dose of 60 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast
Experimental: 100mg group
Single oral dose of 100 mg CL-197 capsules or CL-197 placebo
Drug: 100 mg CL-197 capsules or CL-197 placebo
Single oral dose of 100 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Safety and Tolerability of CL-197 Capsules ：Incidence of Treatment-Emergent Adverse Events as Assessed by The NCI CTCAE V5.0 Grading Criteria
Time Frame: Up to 29 days post-dose
The degree of adverse events observed in the trial would be determined by the NCI CTCAE v5.0 grading criteria, and the adverse events related to the test drug (definitely related, likely to be related, and possibly related) would be terminated in the following cases, and the previous dose would be used as the MTD of the single-dose tolerance test.
Up to 29 days post-dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Peak Plasma Concentration (Cmax) of CL-197 Capsules
Time Frame: Up to 672 hours post-dose in 30mg group and 60 mg group; Up to 162 hours post-dose in other groups
The index components in human blood samples would be measured by LC-MS/MS, and the peak plasma concentration (Cmax) would be calculated.
Up to 672 hours post-dose in 30mg group and 60 mg group; Up to 162 hours post-dose in other groups
The Area Under the Plasma Concentration Versus Time Curve (AUC) of CL-197 Capsules
Time Frame: Up to 672 hours post-dose in 30mg group and 60 mg group; Up to 162 hours post-dose in other groups
The index components in human blood samples would be measured by LC-MS/MS, and the area under the plasma concentration versus time curve (AUC) would be calculated.
Up to 672 hours post-dose in 30mg group and 60 mg group; Up to 162 hours post-dose in other groups
The Elimination Half-Life (t1/2) of CL-197 Capsules
Time Frame: Up to 672 hours post-dose in 30mg group and 60 mg group; Up to 162 hours post-dose in other groups
The index components in human blood samples would be measured by LC-MS/MS, and the elimination half-life (t1/2) would be calculated.
Up to 672 hours post-dose in 30mg group and 60 mg group; Up to 162 hours post-dose in other groups
The Accumulate Urinary Drug Excretion (Ae) of CL-197 Capsules
Time Frame: Up to 672 hours post-dose in 30mg group and 60 mg group; Up to 162 hours post-dose in other groups
The index components in human urine samples would be measured by LC-MS/MS, and the accumulate urinary drug excretion (Ae) would be calculated.
Up to 672 hours post-dose in 30mg group and 60 mg group; Up to 162 hours post-dose in other groups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HeNan Sincere Biotech Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wang Fusheng, Medical Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR-CL-197-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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