HealthyPhase 1NCT07348133
Study of Food Effect on Pharmacokinetics of HMPL-523 Acetate Tablets
A Phase 1 study testing HMPL-523 in people with Healthy, run by Hutchmed at 1 site in China.
Trial summary
This is a single-center, open-label, randomized, three-period, six-sequence study to evaluate the effect of food (high-fat and low-fat) on the PK of HMPL-523. In this study, 18 healthy Chinese participants are planned to be enrolled, randomized in a ratio of 1:1:1:1:1:1 to one of 6 dosing sequences (see dosing… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- 18 participants
- Where
- 1 siteChina
- Study dates
- 11 Dec 2025to 6 Feb 2026
- 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
- Participants can communicate well with the investigator, voluntarily sign the ICF, and agree to comply with the requirements of the study protocol;
- Male and female healthy participants aged 18-45 years (inclusive);
- Body weight ≥ 45 kg (females), or ≥ 50 kg (males), body mass index (BMI) 19-26 kg/m2 (inclusive);
- Participants must commit to using highly effective contraception for both themselves and their sexual partners during the study, and for 180 days after the end of the last study dose, and must not engage in sperm donation, egg donation, or have birth plan.
Who cannot join
- Abnormal and clinically significant results of vital signs, physical examination, 12-lead ECG, chest X-ray (frontal and lateral), laboratory tests (including hematology, blood chemistry, urinalysis, etc.) or serum creatinine above the upper limit of normal at screening;
- Positive for any of the HBsAg, HCV antibody, HIV antibody, or Treponema pallidum antibody;
- History or current evidence of severe or chronic metabolic/endocrine, hepatic, renal, hematological, pulmonary, immunological, cardiovascular, gastrointestinal, genitourinary, neurological or psychiatric diseases;
- Prior history of hypertension;
- Prior history of severe gastrointestinal diseases such as dysphagia, active gastric ulcers, etc., resulting in inability to take oral medication or disorders in absorption of oral medication
- Prior history of gastrointestinal surgery, renal surgery, cholecystectomy, etc. that, in the judgment of the investigator, may affect drug absorption or excretion;
Show all 20Show fewer
- Prior history of drug allergy, or acute allergic rhinitis or food allergy within 2 weeks before screening, or allergy to the active ingredients or excipients of the study drug;
- Use of any prescription drugs and Chinese herbal medicines within 30 days prior to the first dose;
- Use of any over-the-counter drugs, vitamins, and health products within 14 days prior to the first dose;
- Consumption of more than 10 cigarettes per day within 3 months before screening, or those who cannot quit smoking during the study;
- Regular alcohol consumption within 6 months before screening, that is, those who drink more than 14 units of alcohol per week (1 unit = 360 mL of beer, or 45 mL of spirits with an alcohol content of 40%, or 150 mL of wine), or those who cannot abstain from alcohol during the study, or those who are positive for alcohol breath test;
- History of drug abuse or recreational use, or positive for urine drug abuse screen;
- Blood donation (including blood component donation) or blood loss ≥ 400 mL within 3 months prior to screening, use of blood products within 2 months prior to screening, blood donation (including component blood donation) or lost blood ≥ 200 mL within 1 month prior to screening, or a plan to donate blood or blood components during the study or within 1 month after the end of the study;
- Difficulty in blood collection, or a history of needle phobia or blood phobia, or intolerance to blood sampling via venipuncture, or poor evaluation of venous blood collection;
- Those who have participated in clinical trials of other drugs/medical devices and have taken study drugs within 3 months prior to screening;
- Those who have consumed foods, juices or drinks containing alcohol, grapefruit, Seville oranges and caffeine within 72 hours before the first dose, or cannot avoid them during the study;
- Those who have received live vaccines within 8 weeks prior to screening or have plans to be vaccinated during the clinical trial;
- Those who have special dietary requirements and cannot accept a standardized dietary arrangement;
- Pregnant or lactating females, or females with blood pregnancy test results above the upper limit of normal during the screening period, or females with unprotected sex within 2 weeks prior to dosing;
- The study participant, based on the judgment of the investigator, has any other diseases or conditions that may affect the normal completion of the study or the evaluation of study data, or other conditions that make him/her unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250014
About this study
Official title: An Open-Label, Randomized, Three-Period, Six-Sequence Phase I Study to Evaluate the Effect of Food on the Pharmacokinetics of HMPL-523 Acetate Tablets in Healthy Participants
This is a single-center, open-label, randomized, three-period, six-sequence study to evaluate the effect of food (high-fat and low-fat) on the PK of HMPL-523. In this study, 18 healthy Chinese participants are planned to be enrolled, randomized in a ratio of 1:1:1:1:1:1 to one of 6 dosing sequences (see dosing sequence table for details), and administered once per cycle for 3 cycles, with a washout period of at least 7 days. The study consists of a screening/baseline period, a dosing period (three cycles), and a follow-up period.
Read the detailed description
Screening Period/Baseline Period The trial participants will sign a written informed consent form on a voluntary basis prior to screening. Screening period/baseline period assessment will be completed within 14 days prior to the first dose. At screening/baseline, demographic data, medical history, medication history, allergy history, blood donation history, and participation in clinical trials should be collected, and physical examination, vital sign measurements, 12-lead ECG, infection markers, laboratory tests, pregnancy test , and chest X-ray will be performed.
Trial participants who pass the preliminary screening will be admitted to the study site 3 days prior to the first dose (i.e., 3 days prior to medication of Cycle 1), vital signs examination, urine drug abuse screening, alcohol breath screening will be performed on the day of admission, recent dietary and medication use will be inquired, and pregnancy test will be conducted (only for women of childbearing potential. If the screening examinations and baseline examinations will be conducted on the same day, they can be done once), and the inclusion and exclusion criteria will be further checked.
Only serious adverse events will be collected during screening/baseline period. Dosing Period (3 cycles) The day before the first administration, trial participants passing the screening will be given a randomization number according to the randomization scheme, and assigned to one of 6 dosing sequences in a ratio of 1:1:1:1:1:1. The dosing sequences include ABC, ACB, BAC, BCA, CAB and CBA, and the three dietary conditions are fasting (A), standard high-fat breakfast (B) and standard low-fat breakfast (C). Each participant will receive a single oral dose of HMPL-523 acetate tablets 300 mg (3 tablets × 100 mg) on Day 1 of each cycle in accordance with the dosing sequence. During the study, every effort should be made to ensure that the participant takes the medication according to the study protocol.
Administration Method Fasting (A): Participants will fast for at least 10 hours, have blank blood sample collected, and take the study drug with about 240 mL of water. Except for the water for drug administration mentioned above, water will be deprived from 1 hour pre-dose and 1 hour post-dose. Food will be deprived within 4 hours post-dose.
Standard high-fat breakfast (B) or standard low-fat breakfast (C): Participants will fast for at least 10 hours before the standard high-fat breakfast (B) or standard low-fat breakfast (C), start eating breakfast 30 minutes before dosing, and finish the meal within 25 minutes. After the meal, participants will have blank blood sample collected, and take the study drug with about 240 mL of water exactly 30 minutes from the start of the meal. Water will be deprived from 1 hour pre-dose to 1 hour post-dose, except for the beverages included in the prescribed breakfast and water taken with medication. Food will be deprived within 4 hours post-dose.
During hospitalization, the diet of the participants will be provided by the site. On the day of dosing in each cycle, lunch and dinner (both regular meals) will be served 4 hours and 10 hours after dosing, respectively; at other times, 3 meals will be provided according to the schedule arranged by the site.
The dosing period consists of three cycles, and the scheduled PK blood sampling time points for each participant in each cycle are as follows: within 0.5 hours pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 60,and 72 hours post-dose, with a total of 18 collections, and about 3 mL of venous blood will be collected each time. The 4-hour post-dose blood sample must be taken prior to lunch.
After the participants are admitted to the clinical study ward, the vital sign measurements will be performed 1 day pre-dose in each cycle and 3±1 hours post-dose on Day 1 of each cycle. Vital sign measurements, blood chemistry, and hematology will be performed on Day 4 of the each of Cycle 1 and Cycle 2. On Cycle 3 Day 4, the participants will be discharged after vital sign measurements, physical examination, laboratory tests, and 12-lead ECG examination are completed.
Strenuous exercise, alcohol, tobacco, tea, and caffeinated beverages should be avoided during the study. Seville oranges, grapefruits or beverages containing these fruits should be avoided during the study.
Follow-up Period Participants will be followed up to Day 12±2 after the last dose (the day of the last dose is defined as Day 1 of follow-up period). The investigator will collect all (adverse events) AEs and concomitant medications/therapies from the participants during this period through telephone calls (or other means such as text messages). If there are AEs ongoing at follow-up, follow-up will continue until the events return to normal level, abnormal and not clinically significant, baseline level, stable or lost to follow-up, or refusal to visit, etc.
- Conditions
- Healthy
- Being tested
- HMPL-523
- Keywords
- HMPL-523
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMPL-523Drug
The 3 cycles of each sequence consist of 3 dietary conditions, i.e., fasting (A), standard high-fat breakfast (B), and standard low-fat breakfast (C). Participants will receive a single oral dose of HMPL-523 acetate tablets 300 mg on Day 1 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| ABC | Experimental | The 3 cycles of each sequence consist of 3 dietary conditions, i.e., fasting (A), standard high-fat breakfast (B), and standard low-fat breakfast (C). Participants will receive a single oral dose of HMPL-523 acetate tablets 300 mg on Day 1 of each cycle. Receives: Drug: HMPL-523 |
| ACB | Experimental | The 3 cycles of each sequence consist of 3 dietary conditions, i.e., fasting (A), standard high-fat breakfast (B), and standard low-fat breakfast (C). Participants will receive a single oral dose of HMPL-523 acetate tablets 300 mg on Day 1 of each cycle. Receives: Drug: HMPL-523 |
| BAC | Experimental | The 3 cycles of each sequence consist of 3 dietary conditions, i.e., fasting (A), standard high-fat breakfast (B), and standard low-fat breakfast (C). Participants will receive a single oral dose of HMPL-523 acetate tablets 300 mg on Day 1 of each cycle. Receives: Drug: HMPL-523 |
| BCA | Experimental | The 3 cycles of each sequence consist of 3 dietary conditions, i.e., fasting (A), standard high-fat breakfast (B), and standard low-fat breakfast (C). Participants will receive a single oral dose of HMPL-523 acetate tablets 300 mg on Day 1 of each cycle. Receives: Drug: HMPL-523 |
| CAB | Experimental | The 3 cycles of each sequence consist of 3 dietary conditions, i.e., fasting (A), standard high-fat breakfast (B), and standard low-fat breakfast (C). Participants will receive a single oral dose of HMPL-523 acetate tablets 300 mg on Day 1 of each cycle. Receives: Drug: HMPL-523 |
| CBA | Experimental | The 3 cycles of each sequence consist of 3 dietary conditions, i.e., fasting (A), standard high-fat breakfast (B), and standard low-fat breakfast (C). Participants will receive a single oral dose of HMPL-523 acetate tablets 300 mg on Day 1 of each cycle. Receives: Drug: HMPL-523 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t
Area under the plasma concentration-time curve from time zero to the last time point t where the concentration could be accurately determined
Measured: up to one months
AUC0-∞
Area under the plasma concentration-time curve from time 0 to infinity
Measured: up to one months
Cmax
Maximum plasma concentration
Measured: up to one months
Tmax
Other PK parameters of HMPL-523, such as time to Cmax
Measured: up to one months
t1/2
Other PK parameters of HMPL-523, such as terminal elimination half-life
Measured: up to one months
Secondary outcomes (2)
Adverse events rate
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: up to one months
Laboratory tests
Number of participants with abnormal laboratory tests results
Measured: up to one months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start11 Dec 2025
- Primary completion12 Jan 2026
- Study completion6 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by HutchmedThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a single-center, open-label, randomized, three-period, six-sequence study. There are 3 cycles of dosing, and participants will be randomized to 1 of the 6 dosing sequences (ABC, ACB, BAC, BCA, CAB, or CBA). The 3 cycles of each sequence consist of 3 dietary conditions, i.e., fasting (A), standard high-fat breakfast (B), and standard low-fat breakfast (C). Participants will receive a single oral dose of HMPL-523 acetate tablets 300 mg on Day 1 of each cycle.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Zhao, Doctor, Principal investigator, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348133
- Sponsor's protocol ID
- 2025-523-00CH2
- Status last verified
- Feb 2026
- First submitted
- 26 Nov 2025
- Last updated
- 12 Feb 2026
- 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 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Three-Period, Six-Sequence Phase I Study to Evaluate the Effect of Food on the Pharmacokinetics of HMPL-523 Acetate Tablets in Healthy Participants
- ClinicalTrials.gov ID
- NCT07348133
- Acronym / sponsor ID
- 2025-523-00CH2
- Conditions
- Healthy
- Keywords
- HMPL-523
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- HutchmedIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 6 Feb 2026 (actual)
- First posted
- 16 Jan 2026 (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 single-center, open-label, randomized, three-period, six-sequence study to evaluate the effect of food (high-fat and low-fat) on the PK of HMPL-523. In this study, 18 healthy Chinese participants are planned to be enrolled, randomized in a ratio of 1:1:1:1:1:1 to one of 6 dosing sequences (see dosing sequence table for details), and administered once per cycle for 3 cycles, with a washout period of at least 7 days. The study consists of a screening/baseline period, a dosing period (three cycles), and a follow-up period.
Detailed description
Screening Period/Baseline Period The trial participants will sign a written informed consent form on a voluntary basis prior to screening. Screening period/baseline period assessment will be completed within 14 days prior to the first dose. At screening/baseline, demographic data, medical history, medication history, allergy history, blood donation history, and participation in clinical trials should be collected, and physical examination, vital sign measurements, 12-lead ECG, infection markers, laboratory tests, pregnancy test , and chest X-ray will be performed.
Trial participants who pass the preliminary screening will be admitted to the study site 3 days prior to the first dose (i.e., 3 days prior to medication of Cycle 1), vital signs examination, urine drug abuse screening, alcohol breath screening will be performed on the day of admission, recent dietary and medication use will be inquired, and pregnancy test will be conducted (only for women of childbearing potential. If the screening examinations and baseline examinations will be conducted on the same day, they can be done once), and the inclusion and exclusion criteria will be further checked.
Only serious adverse events will be collected during screening/baseline period. Dosing Period (3 cycles) The day before the first administration, trial participants passing the screening will be given a randomization number according to the randomization scheme, and assigned to one of 6 dosing sequences in a ratio of 1:1:1:1:1:1. The dosing sequences include ABC, ACB, BAC, BCA, CAB and CBA, and the three dietary conditions are fasting (A), standard high-fat breakfast (B) and standard low-fat breakfast (C). Each participant will receive a single oral dose of HMPL-523 acetate tablets 300 mg (3 tablets × 100 mg) on Day 1 of each cycle in accordance with the dosing sequence. During the study, every effort should be made to ensure that the participant takes the medication according to the study protocol.
Administration Method Fasting (A): Participants will fast for at least 10 hours, have blank blood sample collected, and take the study drug with about 240 mL of water. Except for the water for drug administration mentioned above, water will be deprived from 1 hour pre-dose and 1 hour post-dose. Food will be deprived within 4 hours post-dose.
Standard high-fat breakfast (B) or standard low-fat breakfast (C): Participants will fast for at least 10 hours before the standard high-fat breakfast (B) or standard low-fat breakfast (C), start eating breakfast 30 minutes before dosing, and finish the meal within 25 minutes. After the meal, participants will have blank blood sample collected, and take the study drug with about 240 mL of water exactly 30 minutes from the start of the meal. Water will be deprived from 1 hour pre-dose to 1 hour post-dose, except for the beverages included in the prescribed breakfast and water taken with medication. Food will be deprived within 4 hours post-dose.
During hospitalization, the diet of the participants will be provided by the site. On the day of dosing in each cycle, lunch and dinner (both regular meals) will be served 4 hours and 10 hours after dosing, respectively; at other times, 3 meals will be provided according to the schedule arranged by the site.
The dosing period consists of three cycles, and the scheduled PK blood sampling time points for each participant in each cycle are as follows: within 0.5 hours pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 60,and 72 hours post-dose, with a total of 18 collections, and about 3 mL of venous blood will be collected each time. The 4-hour post-dose blood sample must be taken prior to lunch.
After the participants are admitted to the clinical study ward, the vital sign measurements will be performed 1 day pre-dose in each cycle and 3±1 hours post-dose on Day 1 of each cycle. Vital sign measurements, blood chemistry, and hematology will be performed on Day 4 of the each of Cycle 1 and Cycle 2. On Cycle 3 Day 4, the participants will be discharged after vital sign measurements, physical examination, laboratory tests, and 12-lead ECG examination are completed.
Strenuous exercise, alcohol, tobacco, tea, and caffeinated beverages should be avoided during the study. Seville oranges, grapefruits or beverages containing these fruits should be avoided during the study.
Follow-up Period Participants will be followed up to Day 12±2 after the last dose (the day of the last dose is defined as Day 1 of follow-up period). The investigator will collect all (adverse events) AEs and concomitant medications/therapies from the participants during this period through telephone calls (or other means such as text messages). If there are AEs ongoing at follow-up, follow-up will continue until the events return to normal level, abnormal and not clinically significant, baseline level, stable or lost to follow-up, or refusal to visit, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- This is a single-center, open-label, randomized, three-period, six-sequence study. There are 3 cycles of dosing, and participants will be randomized to 1 of the 6 dosing sequences (ABC, ACB, BAC, BCA, CAB, or CBA). The 3 cycles of each sequence consist of 3 dietary conditions, i.e., fasting (A), standard high-fat breakfast (B), and standard low-fat breakfast (C). Participants will receive a single oral dose of HMPL-523 acetate tablets 300 mg on Day 1 of each cycle.
| Arm | Type | Receives |
|---|---|---|
| ABC | Experimental | Drug: HMPL-523The 3 cycles of each sequence consist of 3 dietary conditions, i.e., fasting (A), standard high-fat breakfast (B), and standard low-fat breakfast (C). Participants will receive a single oral dose of HMPL-523 acetate tablets 300 mg on Day 1 of each cycle. |
| ACB | Experimental | Drug: HMPL-523The 3 cycles of each sequence consist of 3 dietary conditions, i.e., fasting (A), standard high-fat breakfast (B), and standard low-fat breakfast (C). Participants will receive a single oral dose of HMPL-523 acetate tablets 300 mg on Day 1 of each cycle. |
| BAC | Experimental | Drug: HMPL-523The 3 cycles of each sequence consist of 3 dietary conditions, i.e., fasting (A), standard high-fat breakfast (B), and standard low-fat breakfast (C). Participants will receive a single oral dose of HMPL-523 acetate tablets 300 mg on Day 1 of each cycle. |
| BCA | Experimental | Drug: HMPL-523The 3 cycles of each sequence consist of 3 dietary conditions, i.e., fasting (A), standard high-fat breakfast (B), and standard low-fat breakfast (C). Participants will receive a single oral dose of HMPL-523 acetate tablets 300 mg on Day 1 of each cycle. |
| CAB | Experimental | Drug: HMPL-523The 3 cycles of each sequence consist of 3 dietary conditions, i.e., fasting (A), standard high-fat breakfast (B), and standard low-fat breakfast (C). Participants will receive a single oral dose of HMPL-523 acetate tablets 300 mg on Day 1 of each cycle. |
| CBA | Experimental | Drug: HMPL-523The 3 cycles of each sequence consist of 3 dietary conditions, i.e., fasting (A), standard high-fat breakfast (B), and standard low-fat breakfast (C). Participants will receive a single oral dose of HMPL-523 acetate tablets 300 mg on Day 1 of each cycle. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants can communicate well with the investigator, voluntarily sign the ICF, and agree to comply with the requirements of the study protocol;
- Male and female healthy participants aged 18-45 years (inclusive);
- Body weight ≥ 45 kg (females), or ≥ 50 kg (males), body mass index (BMI) 19-26 kg/m2 (inclusive);
- Participants must commit to using highly effective contraception for both themselves and their sexual partners during the study, and for 180 days after the end of the last study dose, and must not engage in sperm donation, egg donation, or have birth plan.
Key exclusion criteria (20 listed)
- Abnormal and clinically significant results of vital signs, physical examination, 12-lead ECG, chest X-ray (frontal and lateral), laboratory tests (including hematology, blood chemistry, urinalysis, etc.) or serum creatinine above the upper limit of normal at screening;
- Positive for any of the HBsAg, HCV antibody, HIV antibody, or Treponema pallidum antibody;
- History or current evidence of severe or chronic metabolic/endocrine, hepatic, renal, hematological, pulmonary, immunological, cardiovascular, gastrointestinal, genitourinary, neurological or psychiatric diseases;
- Prior history of hypertension;
- Prior history of severe gastrointestinal diseases such as dysphagia, active gastric ulcers, etc., resulting in inability to take oral medication or disorders in absorption of oral medication
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-523The 3 cycles of each sequence consist of 3 dietary conditions, i.e., fasting (A), standard high-fat breakfast (B), and standard low-fat breakfast (C). Participants will receive a single oral dose of HMPL-523 acetate tablets 300 mg on Day 1 of each cycle. | Drug | ABC, ACB, BAC, BCA, CAB, CBA |
Primary outcome
AUC0-t
Time frame: up to one months
Area under the plasma concentration-time curve from time zero to the last time point t where the concentration could be accurately determined
AUC0-∞
Time frame: up to one months
Area under the plasma concentration-time curve from time 0 to infinity
Cmax
Time frame: up to one months
Maximum plasma concentration
Tmax
Time frame: up to one months
Other PK parameters of HMPL-523, such as time to Cmax
t1/2
Time frame: up to one months
Other PK parameters of HMPL-523, such as terminal elimination half-life
2 secondary outcomes
Adverse events rate
Time frame: up to one months
Laboratory tests
Time frame: up to one 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 12 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Wei Zhao, Doctor principal investigator
Shandong First Medical University
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 HMPL-523 in people with Healthy, run by Hutchmed 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 4 inclusion and 20 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 12 Feb 2026. 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?
AUC0-t (time frame: up to one months). The study lists 5 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 12 Feb 2026.