A Study to Evaluate Relative Bioavailability and Food-Effect of HA121-28 Tablet B in Healthy Subjects

March 11, 2022 updated by: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

A Single-dose, Randomized, Open-label, Two-period Crossover, Phase I Study to Evaluate Relative Bioavailability and Food-Effect of HA121-28 Tablet B in Healthy Subjects

The study will be divided into 2 parts. The first part is a relative bioavailability study of HA121-28 tablet A and HA121-28 tablet B, and the second part is a food effect study of HA121-28 tablet B. Both Parts are single-dose, randomized, open-label, two-period crossover study to evaluate relative bioavailability HA121-28 tablet B in healthy subjects and the effect of food on pharmacokinetic profile of HA121-28 tablet B, respectively.

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.

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.
40

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 Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital，Sichuan University

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 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female subjects aged 18 to 45 years (inclusive);
  2. Body weight ≥ 50.0 kg (males) or 45.0 kg (females), body mass index (BMI) ranging from 18.0 to 26 kg/m^2 (inclusive);
  3. Subjects who have normal or abnormal results without clinical significance after medical history, vital signs, 12-lead ECG, physical examination, laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, etc.) and other tests;
  4. Subjects and their partners must take reliable non-hormonal contraceptive measures (such as condoms, non-drug intrauterine device, etc.) from signing informed consent until 6 months after study completion (except those who have taken permanent contraceptive measures, such as bilateral tubal ligation, vasectomy, etc.) and have no sperm or egg donation plan;
  5. Be willing to sign an informed consent form (ICF) and complete the whole trial process according to the study protocol.

Exclusion Criteria:

  1. Subjects with a previous history of allergy to 1 or more drugs or previous known other severe allergic reactions, including clear hypersensitivity to HA121-28 or equivalent and any excipients in this study, any food component;
  2. Inability to swallow oral medications or presence of diseases that affect the safety evaluation and absorption, distribution, metabolism, or excretion of study medication;
  3. Subjects with a clear history of neurological, or psychiatric disorder, or a history of serious cardiovascular, liver and kidney, endocrine, respiratory, blood, digestive and immune diseases, or a history of malignant tumour;
  4. History of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained cardiac arrhythmias, torsional ventricular tachycardia, ventricular tachycardia, QT prolongation syndrome or with symptoms of QT prolongation syndrome and family history (indicated by genetic proof or cardiac sudden death in a close relative at a young age);
  5. Major surgery within 6 months prior to screening or planned surgery during the trial, including cosmetic, dental and oral surgery;
  6. Subjects who had received the Novel Coronavirus vaccine within 1 month prior to screening;
  7. Clinically significant ECG abnormalities: QTcF interval ≥450 ms (males) or 470 ms (females), or history of prolonged QTcF interval;
  8. Any positive result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus antibody (HIV) or treponema pallidum antibody at screening;
  9. Use of any prescription, over-the-counter (OTC), herbal medicine, nutritional supplements or health care products within 14 days prior to screening;
  10. Regular consume of alcohol more than 14 units per week (One unit is equivalent to 285 mL beer, 25 mL spirits or 150 mL wine) within 4 weeks prior to screening, or a positive breath alcohol test at screening;
  11. Subjects who smoke with an average of more than 5 cigarettes a day within 6 months prior to screening and unable to abstain during the study period;
  12. Presence or history of drug abuse within 1 year prior to screening, or positive urine test for drug abuse at screening;
  13. Habitual consumption of excessive drink or food containing caffeine or xanthine, such as coffee (>1100 mL per day), tea (>2200 mL per day), Cola (>2200 mL per day), energy drinks (>1100 mL per day), chocolate (> 510 g per day) within 4 weeks prior to screening, and subjects with special dietary requirements, not following the uniform diet;
  14. History of needles or blood fainting, or have difficulty in blood collection;
  15. Blood loss or donation more than 200 mL, or received blood transfusion within 4 weeks prior to screening, or plan on blood donation during the study period or within 1 month after the study;
  16. Pregnant or lactating females;
  17. Currently participating in other clinical studies, or participated in any clinical study and intake of study medication within 3 months prior to screening;
  18. Not suitable for this study as judged by the investigator for any other reason.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

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: Part 1-Group A
Subjects will receive 200 mg HA121-28 tablet A on Day 1 of the first cycle, followed by tablet B on Day 36 of the second cycle, in the fasted state.
Drug: HA121-28 tablet B
HA121-28 tablet B 200 mg
Drug: HA121-28 tablet A
HA121-28 tablet A 200 mg
Experimental: Part 1-Group B
Subjects will receive 200 mg HA121-28 tablet B on Day 1 of the first cycle, followed by tablet A on Day 36 of the second cycle, in the fasted state.
Drug: HA121-28 tablet B
HA121-28 tablet B 200 mg
Drug: HA121-28 tablet A
HA121-28 tablet A 200 mg
Experimental: Part 2-Group C
Subjects will receive 200 mg HA121-28 tablet B on Day1 of the first cycle in fasted state, followed by tablet B on Day 36 of the second cycle in the fed state.
Drug: HA121-28 tablet B
HA121-28 tablet B 200 mg
Experimental: Part 2-Group D
Subjects will receive 200 mg HA121-28 tablet B on Day 1 of the first cycle in the fed state, followed by tablet B on Day 36 of the second cycle in fasted state.
Drug: HA121-28 tablet B
HA121-28 tablet B 200 mg

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
Pharmacokinetics (PK) of HA121-28 in plasma: Area under the concentration-time Curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf).
Time Frame: predose (0)~288 hours post-dose
AUCinf (unit: ng*h/mL)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf)
predose (0)~288 hours post-dose
Pharmacokinetics (PK) of HA121-28 in plasma: Area under the concentration-time curve (AUC) from the time of dosing to the last measurable concentration (AUClast).
Time Frame: predose (0)~288 hours post-dose.
AUC0-last(unit: ng*h/mL)=Area under the plasma concentration time-curve from zero to the last measured concentration
predose (0)~288 hours post-dose.
Pharmacokinetics (PK) of HA121-28 in plasma: Maximum concentration (Cmax)
Time Frame: predose (0)~288 hours post-dose.
Cmax（ng/mL)=Maximum concentration
predose (0)~288 hours 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
Number of participants with Adverse Events (AEs)
Time Frame: up to Day 51.
An AE is any untoward medical occurrence in a participant administered an IP, whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP. This includes events related to the comparator and events related to the (study) procedures.
up to Day 51.
Number of participants with laboratory value abnormalities and/or adverse events (AEs) .
Time Frame: up to Day 51.
Number of participants with potentially clinically significant laboratory values.
up to Day 51.
Number of participants with vital sign abnormalities and/or adverse events (AEs) .
Time Frame: up to Day 51.
Number of participants with potentially clinically significant vital sign values.
up to Day 51.
Number of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs) .
Time Frame: up to Day 51 .
Number of participants with potentially clinically significant electrocardiogram (ECG) values.
up to Day 51 .

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.
CSPC ZhongQi Pharmaceutical Technology 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 (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.
October 8, 2021

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.
December 19, 2021

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.
March 3, 2022

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).
September 28, 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.
October 8, 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.
October 11, 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.
March 14, 2022

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.
March 11, 2022

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.
November 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.
  • HA122-CSP-005

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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