Healthy SubjectEarly Phase 1NCT05318820
A Clinical Study to Evaluate the Pharmacokinetics and Bioequivalence of HMPL-523 Tablets Produced by Two Different Manufacturers
A Early Phase 1 study testing HMPL-523 in people with Healthy Subject, run by Hutchison Medipharma Limited at 1 site in China.
Trial summary
This is a monocentric, randomized, open-label, single-dose, three-cycle, partial replicate clinical study designed to evaluate the pharmacokinetic profile and bioequivalence of HMPL-523 Tablets produced by two different manufacturers in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject
- What is being tested?
- HMPL-523
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 30 Sep 2022
- Phase
- Early 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects can communicate well with investigators, must be voluntary and sign the ICF, and agree to comply with the requirements in the study protocol;
- Healthy male and female subjects aged 18-55 years (inclusive);
- Weight ≥50 kg, Body Mass Index (BMI) between 19-26 kg/m2 (inclusive);
- Subjects with good health condition
- Subjects of childbearing potential must promise to use reliable contraceptive measures.
Who cannot join
- History or clinical characterization of clinically significant metabolic/endocrine, hepatic, renal, hematological, pulmonary, immune, cardiovascular, gastrointestinal, genitourinary, neurological, or psychiatric diseases within 3 months prior to the screening period and in the screening period (judged by investigators);
- creatinine clearance estimated using Cockcroft-Gault formula [(140-age) × body weight (kg) × gender correction factor] /[0.818×Scr (umol/L)] (male: 1.00, female: 0.85) < 80 mL/min;
- History of gastrointestinal surgery, kidney surgery, cholecystectomy and other surgeries that might affect drug absorption or excretion judged by the investigator;
- History of serious allergy (e.g., drug allergy) and acute allergic rhinitis or food allergy, in particular allergy to the active ingredient or excipient of study drug, within two weeks prior to screening;
- Previous history of hypertension;
- Systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg;
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- Female subjects who have a positive pregnancy test;
- Subjects who smoked >10 cigarettes per day within 3 months prior to screening, or are unable to quit smoking completely during the study;
- Subjects who drank on a regular basis within 6 months prior to the study, i.e., drinking more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine);
- Subjects with drug abuse (including but not limited to Morphine, 3,4-methylenedioxy-methamphetamine (MDMA), methamphetamine, tetrahydrocannabinolic acid, Ketamine, Cocaine or subjects whose urine drug abuse screen showed positive);
- Use of blood products within 2 months before screening; donation of blood (including blood component) or loss of blood ≥400 mL within 3 months prior to screening, ≥200 mL within 1 month prior to screening, or plan to donate blood or blood component during the study or within 1 month after end of the study;
- Subjects who have a fear of needles, hemophobia or whose venous blood is hard to collect;
- Positive test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody;
- Use of any prescription drug and Chinese herbal tonic within 30 days prior to the first dose;
- Use of any over-the-counter drug (including but not limited to vitamins, prophylactic treatments, plant health products, etc.) within 14 days prior to the first dose;
- Having participated in clinical trials for other drugs/medical devices within 3 months prior to screening;
- Having consumed foods, juices and beverages containing alcohol, grapefruit, bigarade and caffeine within 72 hours prior to the first dose;
- Subjects vaccinated with a live-attenuated vaccine within 8 weeks prior to screening or planning to get vaccinated during participation of this clinical trial;
- Previous history of serious gastrointestinal disease, such as dysphagia, active gastric ulcer, inability to take drugs orally or absorption disorder for oral drugs;
- Subjects who have special requirements for diet and cannot comply with uniform diet;
- Lactating female subjects;
- According to the investigator's judgment, the subjects had any other disease or status that might affect the normal completion of the study or the evaluation of the study data, or had any other condition that was not suitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Monocentric, Open-label, Randomized, Crossover Clinical Study to Evaluate the Pharmacokinetics and Bioequivalence of HMPL-523 Tablets Produced by Two Different Manufacturers in Healthy Chinese Subjects
This is a monocentric, randomized, open-label, single-dose, three-cycle, partial replicate clinical study designed to evaluate the pharmacokinetic profile and bioequivalence of HMPL-523 Tablets produced by two different manufacturers in healthy subjects.
Read the detailed description
This is a monocentric, randomized, open-label, single-dose, three-cycle, partial replicate clinical study designed to evaluate the pharmacokinetic profile and bioequivalence of HMPL-523 Tablets produced by two different manufacturers in healthy subjects. This study plans to enroll 39 healthy Chinese subjects who will be randomized (1:1:1) into one of three sequence groups (Test [T]/Reference[R]/R group, RTR group and RRT group) to receive a single dose in each cycle with a washout period of at least 7 days, where T is the test product [i.e., HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Limited.], and R is the reference product (i.e., HMPL-523 Tablets manufactured by WuXi STA).
The study includes three periods expected to last for 2 months: screening period, treatment period (for three cycles), and follow-up period
- Conditions
- Healthy Subject
- Being tested
- HMPL-523
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMPL-523Drug
This study plans to enroll 39 healthy Chinese subjects who will be randomized (1:1:1) into one of three sequence groups (Test [T]/Reference[R]/R group, RTR group and RRT group) to receive a single dose in each cycle with a washout period of at least 7 days, where T is the test product [i.e., HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Limited.], and R is the reference product (i.e., HMPL-523 Tablets manufactured by WuXi STA).
| Study group | Role | What they receive |
|---|---|---|
| HMPL-523-TRR | Experimental | Three cycle dose: TRR Test product: HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Co., Ltd.; Reference product: HMPL-523 Tablets manufactured by WuXi STA Receives: Drug: HMPL-523 |
| HMPL-523-RTR | Experimental | Three cycle dose:RTR Test product: HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Co., Ltd.; Reference product: HMPL-523 Tablets manufactured by WuXi STA Receives: Drug: HMPL-523 |
| HMPL-523-RRT | Experimental | Three cycle dose:RRT Test product: HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Co., Ltd.; Reference product: HMPL-523 Tablets manufactured by WuXi STA Receives: Drug: HMPL-523 |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum plasma concentration (Cmax)
To evaluate the pharmacokinetics and bioequivalence of HMPL- 523 Tablets 300 mg (100 mg/tablet×3) (produced by two different manufacturers) taken orally in a single dose after a standard meal in healthy Chinese subjects
Measured: through study completion, an average of 2 months
time to maximum plasma concentration (Tmax)
To evaluate the pharmacokinetics and bioequivalence of HMPL- 523 Tablets 300 mg (100 mg/tablet×3) (produced by two different manufacturers) taken orally in a single dose after a standard meal in healthy Chinese subjects
Measured: Time Frame: through study completion, an average of 2 months
terminal elimination half-life (t1/2)
To evaluate the pharmacokinetics and bioequivalence of HMPL- 523 Tablets 300 mg (100 mg/tablet×3) (produced by two different manufacturers) taken orally in a single dose after a standard meal in healthy Chinese subjects
Measured: through study completion, an average of 2 months
Area under plasma drug concentration-time curve (AUC0-t, AUC0-∞)
To evaluate the pharmacokinetics and bioequivalence of HMPL- 523 Tablets 300 mg (100 mg/tablet×3) (produced by two different manufacturers) taken orally in a single dose after a standard meal in healthy Chinese subjects
Measured: through study completion, an average of 2 months
Secondary outcomes (2)
Ratio between AUCs of two HMPL-523 Tablets
To compare the relative bioavailability of HMPL-523 Tablet 300 mg (100 mg/tablet ×3) produced by two different manufacturers
Measured: through study completion, an average of 2 months
safety information/AE,SAE
To observe the safety of HMPL-523 Tablet 300 mg (100 mg/tablet ×3) taken orally in a single dose after a standard meal in healthy Chinese subjects
Measured: through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start1 Jun 2022
- Primary completion31 Jul 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a monocentric, randomized, open-label, single-dose, three-cycle, partial replicate clinical study designed to evaluate the pharmacokinetic profile and bioequivalence of HMPL-523 Tablets produced by two different manufacturers in healthy subjects. This study plans to enroll 39 healthy Chinese subjects who will be randomized (1:1:1) into one of three sequence groups (Test \[T\]/Reference\[R\]/R group, RTR group and RRT group) to receive a single dose in each cycle with a washout period of at least 7 days, where T is the test product \[i.e., HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Limited.\], and R is the reference product (i.e., HMPL-523 Tablets manufactured by WuXi STA).
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchison Medipharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jingying Jia, Principal investigator, Xuhui Central Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318820
- Sponsor's protocol ID
- 2021-523-00CH1
- Status last verified
- Apr 2023
- First submitted
- 9 Mar 2022
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Monocentric, Open-label, Randomized, Crossover Clinical Study to Evaluate the Pharmacokinetics and Bioequivalence of HMPL-523 Tablets Produced by Two Different Manufacturers in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT05318820
- Acronym / sponsor ID
- 2021-523-00CH1
- Conditions
- Healthy Subject
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 8 Apr 2022 (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.
This is a monocentric, randomized, open-label, single-dose, three-cycle, partial replicate clinical study designed to evaluate the pharmacokinetic profile and bioequivalence of HMPL-523 Tablets produced by two different manufacturers in healthy subjects.
Detailed description
This is a monocentric, randomized, open-label, single-dose, three-cycle, partial replicate clinical study designed to evaluate the pharmacokinetic profile and bioequivalence of HMPL-523 Tablets produced by two different manufacturers in healthy subjects. This study plans to enroll 39 healthy Chinese subjects who will be randomized (1:1:1) into one of three sequence groups (Test [T]/Reference[R]/R group, RTR group and RRT group) to receive a single dose in each cycle with a washout period of at least 7 days, where T is the test product [i.e., HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Limited.], and R is the reference product (i.e., HMPL-523 Tablets manufactured by WuXi STA).
The study includes three periods expected to last for 2 months: screening period, treatment period (for three cycles), and follow-up period
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a monocentric, randomized, open-label, single-dose, three-cycle, partial replicate clinical study designed to evaluate the pharmacokinetic profile and bioequivalence of HMPL-523 Tablets produced by two different manufacturers in healthy subjects. This study plans to enroll 39 healthy Chinese subjects who will be randomized (1:1:1) into one of three sequence groups (Test [T]/Reference[R]/R group, RTR group and RRT group) to receive a single dose in each cycle with a washout period of at least 7 days, where T is the test product [i.e., HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Limited.], and R is the reference product (i.e., HMPL-523 Tablets manufactured by WuXi STA).
| Arm | Type | Receives |
|---|---|---|
| HMPL-523-TRR | Experimental | Drug: HMPL-523Three cycle dose: TRR Test product: HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Co., Ltd.; Reference product: HMPL-523 Tablets manufactured by WuXi STA |
| HMPL-523-RTR | Experimental | Drug: HMPL-523Three cycle dose:RTR Test product: HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Co., Ltd.; Reference product: HMPL-523 Tablets manufactured by WuXi STA |
| HMPL-523-RRT | Experimental | Drug: HMPL-523Three cycle dose:RRT Test product: HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Co., Ltd.; Reference product: HMPL-523 Tablets manufactured by WuXi STA |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects can communicate well with investigators, must be voluntary and sign the ICF, and agree to comply with the requirements in the study protocol;
- Healthy male and female subjects aged 18-55 years (inclusive);
- Weight ≥50 kg, Body Mass Index (BMI) between 19-26 kg/m2 (inclusive);
- Subjects with good health condition
- Subjects of childbearing potential must promise to use reliable contraceptive measures.
Key exclusion criteria (22 listed)
- History or clinical characterization of clinically significant metabolic/endocrine, hepatic, renal, hematological, pulmonary, immune, cardiovascular, gastrointestinal, genitourinary, neurological, or psychiatric diseases within 3 months prior to the screening period and in the screening period (judged by investigators);
- creatinine clearance estimated using Cockcroft-Gault formula [(140-age) × body weight (kg) × gender correction factor] /[0.818×Scr (umol/L)] (male: 1.00, female: 0.85) < 80 mL/min;
- History of gastrointestinal surgery, kidney surgery, cholecystectomy and other surgeries that might affect drug absorption or excretion judged by the investigator;
- History of serious allergy (e.g., drug allergy) and acute allergic rhinitis or food allergy, in particular allergy to the active ingredient or excipient of study drug, within two weeks prior to screening;
- Previous history of hypertension;
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 |
|---|---|---|
| HMPL-523This study plans to enroll 39 healthy Chinese subjects who will be randomized (1:1:1) into one of three sequence groups (Test [T]/Reference[R]/R group, RTR group and RRT group) to receive a single dose in each cycle with a washout period of at least 7 days, where T is the test product [i.e., HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Limited.], and R is the reference product (i.e., HMPL-523 Tablets manufactured by WuXi STA). | Drug | HMPL-523-RRT, HMPL-523-RTR, HMPL-523-TRR |
Primary outcome
maximum plasma concentration (Cmax)
Time frame: through study completion, an average of 2 months
To evaluate the pharmacokinetics and bioequivalence of HMPL- 523 Tablets 300 mg (100 mg/tablet×3) (produced by two different manufacturers) taken orally in a single dose after a standard meal in healthy Chinese subjects
time to maximum plasma concentration (Tmax)
Time frame: Time Frame: through study completion, an average of 2 months
To evaluate the pharmacokinetics and bioequivalence of HMPL- 523 Tablets 300 mg (100 mg/tablet×3) (produced by two different manufacturers) taken orally in a single dose after a standard meal in healthy Chinese subjects
terminal elimination half-life (t1/2)
Time frame: through study completion, an average of 2 months
To evaluate the pharmacokinetics and bioequivalence of HMPL- 523 Tablets 300 mg (100 mg/tablet×3) (produced by two different manufacturers) taken orally in a single dose after a standard meal in healthy Chinese subjects
Area under plasma drug concentration-time curve (AUC0-t, AUC0-∞)
Time frame: through study completion, an average of 2 months
To evaluate the pharmacokinetics and bioequivalence of HMPL- 523 Tablets 300 mg (100 mg/tablet×3) (produced by two different manufacturers) taken orally in a single dose after a standard meal in healthy Chinese subjects
2 secondary outcomes
Ratio between AUCs of two HMPL-523 Tablets
Time frame: through study completion, an average of 2 months
safety information/AE,SAE
Time frame: through study completion, an average of 2 months
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 25 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Jingying Jia principal investigator
Xuhui Central Hospital, Shanghai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing HMPL-523 in people with Healthy Subject, run by Hutchison Medipharma Limited 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 22 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 25 Apr 2023. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
maximum plasma concentration (Cmax) (time frame: through study completion, an average of 2 months). The study lists 4 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 25 Apr 2023.