Chinese Healthy VolunteersPhase 1NCT07566572
A Study of BGM0504 Tablets in Healthy Chinese Subjects
A Phase 1 study testing BGM0504 tablets in people with Chinese Healthy Volunteers, run by BrightGene Bio-Medical Technology Co., Ltd. at 1 site in China.
Trial summary
A randomized, open-label, multiple-dose study to evaluate the effects of high-fat meals and different administration conditions (including water intake and fasting time) on the pharmacokinetics of BGM0504 tablets at a dose of 20mg in healthy Chinese participants and to assess its safety and tolerability. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chinese Healthy Volunteers
- What is being tested?
- BGM0504 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2026to 31 Aug 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ○ Between the ages of 18 and 55 years (inclusive) at the time of screening, both male and female;
- weight ≥ 50 kg, and body mass index (BMI): 24.0 kg/m² ≤ BMI < 30 kg/m²（BMI = weight/height²）;
- (Medical Inquiry) Have a stable body weight (<5% self-reported change during the previous 12 weeks) before screening.
- Participants should be willing to take effective contraceptive measures from the date of signing the informed consent form until 3 months after the last administration, and have no plans for sperm or egg donation.
- Participants who were determined to be generally healthy by the investigator based on their past medical history, physical examination, vital signs, laboratory tests and electrocardiogram examinations.
Who cannot join
- ● (Medical Inquiry) Individuals with a history of severe drug allergies (especially known or suspected allergies to the components and excipients of BGM0504 tablets) or those with severe specific allergic diseases/diseases history or severe allergic constitution;
- (Medical Inquiry) Individuals who have previously suffered from or currently have major diseases in the nervous system, cardiovascular system, digestive system, respiratory system, urinary system, endocrine system, blood system or immune system, and are judged by the investigator to be unsuitable to participate in this trial;
- (Examination) Any laboratory test results judged by the investigator as abnormal and of clinical significance;
- (Medical Inquiry/Examination) Individuals who previously had obvious gastrointestinal diseases or related symptoms (such as nausea, vomiting, heartburn sensation or diarrhea), affected gastric emptying (such as pyloric stenosis), or had undergone any gastrointestinal surgery (except for intestinal polyp resection and appendectomy), or had acute diarrhea, constipation within the 7 days before randomization; Diarrhea is defined as watery stools and/or daily defecation ≥ 3 times. Constipation is defined as the inability to achieve at least one defecation per day;
- (Medical Inquiry/Examination) During the screening, individuals with acute cholecystitis, chronic cholecystitis; or those with symptomatic or treatable gallstones at the time of screening; or those with symptomatic or treatable gallbladder polyps at the time of screening;
- (Medical Inquiry) Individuals previously diagnosed with thyroid C-cell carcinoma, MEN (Multiple Endocrine Adenoma Disease) type 2A or 2B, or with a related family history;
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- (Medical Inquiry) Individuals previously diagnosed with acute or chronic pancreatitis, or pancreatic injury;
- (Medical Inquiry/Query) Individuals who used any prescription drugs or over-the-counter drugs (including chemical drugs, vitamin drugs, herbal drugs, etc.) within 2 weeks before screening;
- (Examination) Individuals with any positive results for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody during the screening period;
- (Examination) At the screening/baseline, 12-lead electrocardiogram shows a heart rate of < 50 beats per minute or > 100 beats per minute, second or third degree atrioventricular conduction block, long QT syndrome or for women QTcF > 470 ms or for men > 450 ms or other electrocardiogram abnormalities judged by the investigator as requiring drug intervention;
- (Medical Inquiry) Individuals with a history of fainting during blood transfusion or needle phobia;
- (Medical Inquiry) Individuals who have taken drugs or had drug abuse history within 6 months before screening;
- (Medical Inquiry) Individuals who smoked more than 10 cigarettes per day on average (including nicotine replacement products) within 3 months before screening, or who could not prohibit smoking throughout the trial stay;
- (Medical Inquiry) Individuals who frequently drank alcohol within the 3 months before screening, that is, with an average daily alcohol intake of more than 2 units (1 unit = 17.7 mL ethanol, that is, 1 unit = 357 mL alcohol for 5% beer or 43 mL alcohol for 40% liquor or 147 mL alcohol for 12% wine) or who could not abstain from alcohol throughout the trial stay;
- (Medical Inquiry) Individuals who donated blood or lost more than 400 mL of blood within 3 months before screening or plan to donate blood during or after the trial;
- (Medical Inquiry/Query) Individuals who participated in drug or medical device clinical trials and received trial drugs (except for placebo) or medical device interventions within 3 months before screening;
- (Medical Inquiry) Individuals who received any vaccine or plan to receive a vaccine during screening;
- (Medical Inquiry/Examination) Female participants who are pregnant or lactating, or those with positive pregnancy test results during the screening period;
- (Examination) Individuals with positive urine drug or alcohol breath screening at the baseline period;
- Individuals determined by the investigator to be unsuitable to participate in this study or who withdrew from the study for personal reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Multiple-dose Phase I Clinical Study to Evaluate the Effect of a High-fat Meal and Different Dosing Conditions on the Pharmacokinetics of BGM0504 Tablets in Healthy Chinese Participants.
A randomized, open-label, multiple-dose study to evaluate the effects of high-fat meals and different administration conditions (including water intake and fasting time) on the pharmacokinetics of BGM0504 tablets at a dose of 20mg in healthy Chinese participants and to assess its safety and tolerability.
- Conditions
- Chinese Healthy Volunteers
- Being tested
- BGM0504 tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGM0504 tabletsDrug
Administered p.o.
| Study group | Role | What they receive |
|---|---|---|
| BGM0504 tablets | Experimental | Oral administration once daily Receives: Drug: BGM0504 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK) endpoint： AUC0-tau,ss
Measured: 4 weeks
PK endpoint：Cmax,ss
Measured: 4 weeks
PK endpoint：t1/2,ss
Measured: 4 weeks
Secondary outcomes (5)
Pharmacodynamics (PD) endpoint：Changes in fasting blood glucose
Measured: 6 weeks
PD endpoint：waist circumference before and after administration
Measured: 6 weeks
PD endpoint：body weight before and after administration
Measured: 6 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 6 weeks
Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start26 Mar 2026
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chinese Healthy VolunteersStudies 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
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrightGene Bio-Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566572
- Sponsor's protocol ID
- BGM0504-CPK-102
- Status last verified
- Oct 2026
- First submitted
- 22 Apr 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple-dose Phase I Clinical Study to Evaluate the Effect of a High-fat Meal and Different Dosing Conditions on the Pharmacokinetics of BGM0504 Tablets in Healthy Chinese Participants.
- ClinicalTrials.gov ID
- NCT07566572
- Acronym / sponsor ID
- BGM0504-CPK-102
- Conditions
- Chinese Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- BrightGene Bio-Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 5 May 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.
A randomized, open-label, multiple-dose study to evaluate the effects of high-fat meals and different administration conditions (including water intake and fasting time) on the pharmacokinetics of BGM0504 tablets at a dose of 20mg in healthy Chinese participants and to assess its safety and tolerability.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BGM0504 tablets | Experimental | Drug: BGM0504 tabletsOral administration once daily |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ○ Between the ages of 18 and 55 years (inclusive) at the time of screening, both male and female;
Key exclusion criteria (20 listed)
- ● (Medical Inquiry) Individuals with a history of severe drug allergies (especially known or suspected allergies to the components and excipients of BGM0504 tablets) or those with severe specific allergic diseases/diseases history or severe allergic constitution;
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 |
|---|---|---|
| BGM0504 tabletsAdministered p.o. | Drug | BGM0504 tablets |
Primary outcome
Pharmacokinetic (PK) endpoint： AUC0-tau,ss
Time frame: 4 weeks
PK endpoint：Cmax,ss
Time frame: 4 weeks
PK endpoint：t1/2,ss
Time frame: 4 weeks
5 secondary outcomes
Pharmacodynamics (PD) endpoint：Changes in fasting blood glucose
Time frame: 6 weeks
PD endpoint：waist circumference before and after administration
Time frame: 6 weeks
PD endpoint：body weight before and after administration
Time frame: 6 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 6 weeks
Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0
Time frame: 6 weeks
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 13 Oct 2026.
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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 BGM0504 tablets in people with Chinese Healthy Volunteers, run by BrightGene Bio-Medical 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 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 13 Oct 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?
Pharmacokinetic (PK) endpoint： AUC0-tau,ss (time frame: 4 weeks). 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 13 Oct 2026.