A Trial to Evaluate the Safety and PK Profile of HRS4800 in Healthy Subjects

April 27, 2021 updated by: Jiangsu HengRui Medicine Co., Ltd.

A Phase 1, Single Center, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, on the Pharmacokinetics of HRS4800 in Healthy Male Subjects

The study will be conducted to evaluate the safety and PK profile of HRS4800 tablets after single oral administration in different dose levels compared to placebo.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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.

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 (Anticipated)

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.
50

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 Contact Backup

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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Able to understand the purposes and risks of the trial and comply with all study procedures before entering the trial, and provide signed informed consent.
  2. Male aged between 18 years and 55 years at screening, inclusive.
  3. Total body weight ≥50 kg at screening, and body mass index (BMI) between 19.0 and 26.0 kg/m2, inclusive.
  4. Agree to take contraceptive measures and promise not to donate sperm since signing the informed consent form, to 3 months after the administration.
  5. No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry, coagulation function), and ECG, as determined by the investigator.

Exclusion Criteria:

  1. History of severe digestive system disease or having a digestive disease currently within 3 months of screening or before first dosing, and may affect drug absorption or have safety risks.
  2. Severe infections, injuries or surgeries within 3 months of screening or before first dosing, or plan to undergo any surgeries during the trial.
  3. ALT, AST, ALP or total bilirubin level exceeds the upper limit of normal (ULN) during screening/baseline visits.
  4. Subject's supine systolic BP is ≥140 mmHg or <90 mmHg; diastolic BP ≥90 mmHg or <60 mmHg at screening or before first dosing.
  5. Positive breath alcohol test after confirmation in a repeat test during screening/baseline visits.
  6. Positive drug screening tests,.
  7. Whole blood donation or loss of more than 200 mL of blood within 1 month prior to dosing; or blood donation or loss of more than 400 mL of blood within 3 months prior to dosing; or received blood within 2 months prior to dosing.
  8. History of allergy to the study drug or any component of it.

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: Triple

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.
Placebo Comparator: placebo
Drug: placebo
  1. Drug: placebo Low-dose group, single oral administration
  2. Drug: placebo Low-medium dose group, single oral administration
  3. Drug: placebo medium -dose group, single oral administration
  4. Drug: placebo Medium and high dose group, single oral administration
  5. Drug: placebo High-dose group, single oral administration
Experimental: HRS4800 tablets
Drug: HRS4800 tablets
  1. Drug: HRS4800 tablets Low-dose group, single oral administration
  2. Drug: HRS4800 tablets Low-medium dose group, single oral administration
  3. Drug: HRS4800 tablets medium -dose group, single oral administration
  4. Drug: HRS4800 tablets Medium and high dose group, single oral administration
  5. Drug: HRS4800 tablets High-dose group, single oral administration

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
Time Frame
Proportion of Participants with Adverse Events (AEs)
Time Frame: 1-21 days
1-21 days
Proportion of Participants with Hematology, Clinical Chemistry, Urinalysis Laboratory Abnormalities
Time Frame: 1-21 days
1-21 days
Proportion of Participants with 12-lead electrocardiograms (ECG) Abnormalities
Time Frame: 1-21 days
1-21 days
Proportion of Participants with Vital Sign and Physical Examinations Abnormalities
Time Frame: 1-21 days
1-21 days

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
Time Frame
Maximum Observed Plasma Concentration (Cmax) of HRS4800,
Time Frame: 1-6 days
1-6 days
Time to Attain Maximum Observed Plasma Concentration (Tmax) of HRS4800,
Time Frame: 1-6 days
1-6 days
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC[last]) of HRS4800,
Time Frame: 1-6 days
1-6 days
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of HRS4800
Time Frame: 1-6 days
1-6 days
Apparent Terminal Elimination Half-Life (t1/2) of HRS4800,
Time Frame: 1-6 days
1-6 days
Elimination Rate Constant (λz, or kel) of HRS4800,
Time Frame: 1-6 days
1-6 days
Apparent Volume of Distribution (VZ/F) During Terminal Phase of HRS4800
Time Frame: 1-6 days
1-6 days
Total HRS4800 of Cumulative Amount Excreted in Urine (Aeu)
Time Frame: 1-6 days
1-6 days
Total HRS4800 of Fraction of Dose Excreted in Urine (feu)
Time Frame: 1-6 days
1-6 days

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.
Jiangsu HengRui Medicine Co., Ltd.

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 (Anticipated)

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.
May 3, 2021

Primary Completion (Anticipated)

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.
September 3, 2021

Study Completion (Anticipated)

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.
September 24, 2021

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).
April 19, 2021

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.
April 27, 2021

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.
April 28, 2021

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 28, 2021

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 27, 2021

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, 2021

More Information

Terms related to this study

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.
  • HRS4800-101

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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