Healthy SubjectsPhase 1NCT05072535
A Study to Evaluate Relative Bioavailability and Food-Effect of HA121-28 Tablet B in Healthy Subjects
A Phase 1 study testing HA121-28 tablet B and HA121-28 tablet A in people with Healthy Subjects, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- HA121-28 tablet B and HA121-28 tablet A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2021to 3 Mar 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects aged 18 to 45 years (inclusive);
- 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);
- 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;
- 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;
- Be willing to sign an informed consent form (ICF) and complete the whole trial process according to the study protocol.
Who cannot join
- 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;
- Inability to swallow oral medications or presence of diseases that affect the safety evaluation and absorption, distribution, metabolism, or excretion of study medication;
- 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;
- 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);
- Major surgery within 6 months prior to screening or planned surgery during the trial, including cosmetic, dental and oral surgery;
- Subjects who had received the Novel Coronavirus vaccine within 1 month prior to screening;
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- Clinically significant ECG abnormalities: QTcF interval ≥450 ms (males) or 470 ms (females), or history of prolonged QTcF interval;
- 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;
- Use of any prescription, over-the-counter (OTC), herbal medicine, nutritional supplements or health care products within 14 days prior to screening;
- 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;
- 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;
- Presence or history of drug abuse within 1 year prior to screening, or positive urine test for drug abuse at screening;
- 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;
- History of needles or blood fainting, or have difficulty in blood collection;
- 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;
- Pregnant or lactating females;
- Currently participating in other clinical studies, or participated in any clinical study and intake of study medication within 3 months prior to screening;
- Not suitable for this study as judged by the investigator for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Subjects
- Being tested
- HA121-28 tablet B, HA121-28 tablet A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HA121-28 tablet BDrug
HA121-28 tablet B 200 mg
HA121-28 tablet ADrug
HA121-28 tablet A 200 mg
| Study group | Role | What they receive |
|---|---|---|
| Part 1-Group A | Experimental | 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. Receives: Drug: HA121-28 tablet B; Drug: HA121-28 tablet A |
| Part 1-Group B | Experimental | 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. Receives: Drug: HA121-28 tablet B; Drug: HA121-28 tablet A |
| Part 2-Group C | Experimental | 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. Receives: Drug: HA121-28 tablet B |
| Part 2-Group D | Experimental | 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. Receives: Drug: HA121-28 tablet B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of HA121-28 in plasma: Area under the concentration-time Curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf).
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)
Measured: 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).
AUC0-last(unit: ng*h/mL)=Area under the plasma concentration time-curve from zero to the last measured concentration
Measured: predose (0)~288 hours post-dose.
Pharmacokinetics (PK) of HA121-28 in plasma: Maximum concentration (Cmax)
Cmax（ng/mL)=Maximum concentration
Measured: predose (0)~288 hours post-dose.
Secondary outcomes (4)
Number of participants with Adverse Events (AEs)
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.
Measured: up to Day 51.
Number of participants with laboratory value abnormalities and/or adverse events (AEs) .
Number of participants with potentially clinically significant laboratory values.
Measured: up to Day 51.
Number of participants with vital sign abnormalities and/or adverse events (AEs) .
Number of participants with potentially clinically significant vital sign values.
Measured: up to Day 51.
Number of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs) .
Number of participants with potentially clinically significant electrocardiogram (ECG) values.
Measured: up to Day 51 .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start8 Oct 2021
- Primary completion19 Dec 2021
- Study completion3 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072535
- Sponsor's protocol ID
- HA122-CSP-005
- Status last verified
- Nov 2021
- First submitted
- 28 Sep 2021
- Last updated
- 14 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05072535
- Acronym / sponsor ID
- HA122-CSP-005
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 19 Dec 2021 (actual)
- Study completion
- 3 Mar 2022 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1-Group A | Experimental | Drug: HA121-28 tablet B, Drug: HA121-28 tablet ASubjects 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. |
| Part 1-Group B | Experimental | Drug: HA121-28 tablet B, Drug: HA121-28 tablet ASubjects 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. |
| Part 2-Group C | Experimental | Drug: HA121-28 tablet BSubjects 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. |
| Part 2-Group D | Experimental | Drug: HA121-28 tablet BSubjects 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female subjects aged 18 to 45 years (inclusive);
- 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);
- 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;
- 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;
- Be willing to sign an informed consent form (ICF) and complete the whole trial process according to the study protocol.
Key exclusion criteria (18 listed)
- 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;
- Inability to swallow oral medications or presence of diseases that affect the safety evaluation and absorption, distribution, metabolism, or excretion of study medication;
- 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;
- 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);
- Major surgery within 6 months prior to screening or planned surgery during the trial, including cosmetic, dental and oral surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HA121-28 tablet BHA121-28 tablet B 200 mg | Drug | Part 1-Group A, Part 1-Group B, Part 2-Group C, Part 2-Group D |
| HA121-28 tablet AHA121-28 tablet A 200 mg | Drug | Part 1-Group A, Part 1-Group B |
Primary outcome
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)
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
Pharmacokinetics (PK) of HA121-28 in plasma: Maximum concentration (Cmax)
Time frame: predose (0)~288 hours post-dose.
Cmax（ng/mL)=Maximum concentration
4 secondary outcomes
Number of participants with Adverse Events (AEs)
Time frame: 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 vital sign abnormalities and/or adverse events (AEs) .
Time frame: up to Day 51.
Number of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs) .
Time frame: up to Day 51 .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HA121-28 tablet B and HA121-28 tablet A in people with Healthy Subjects, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.