Healthy Adult SubjectPhase 1NCT07594847
A Study of HDM1002 Tablets on Cardiac Repolarization in Healthy Subjects
A Phase 1 study testing HDM1002 200 mg, HDM1002 400 mg and Moxifloxacin 400 mg in people with Healthy Adult Subject, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The aim of this trial is to evaluate the effect of a single oral dose of HDM1002 tablets on the QT/QTc interval in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subject
- What is being tested?
- HDM1002 200 mg, HDM1002 400 mg and Moxifloxacin 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 7 Mar 2026to 6 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- The subject has voluntarily signed a written informed consent form.
- Male or female; age between 18 and 45 years (inclusive).
- Subject's weight ≥50 kg, with a body mass index (BMI) between 19.0 and 28.0 kg/m2, inclusive. BMI = weight (kg) / height2 (m2).
- Medical history inquiry, physical examination, laboratory test items, and other trial-related tests at screening are all normal or show mild abnormalities with no clinical significance, and the subject is judged to be eligible by the clinical research physician.
- The subject is able to communicate well with the investigator and comply with the protocol requirements to complete the study.
Who cannot join
- History of or current neurological/psychiatric, respiratory, cardiovascular, gastrointestinal, hematological and lymphatic, endocrine, or musculoskeletal system diseases, hepatic or renal insufficiency, or any other disease or physiological condition that may affect the study results;
- Subjects with a personal or family history of medullary thyroid cancer (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2);
- History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening;
- History of a cholecystitis episode within 3 months prior to screening;
- History of allergy to HDM1002, moxifloxacin hydrochloride tablets, other fluoroquinolones or quinolones, or any of the excipients; or history of food allergy, or a specific allergy history (asthma, urticaria, eczema, etc.);
- Clinically significant major illness or undergone major surgery within 3 months prior to the trial;
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- Blood donation within 3 months, or plans to donate blood during this study, or transfusion or blood loss ≥200 mL within 4 weeks prior to the trial;
- Has consumed a special diet, engaged in strenuous exercise, or had other factors that affect drug absorption, distribution, metabolism, and excretion within 48 hours prior to dosing;
- Pregnant or lactating, or has a positive blood pregnancy test result;
- The investigator believes that the subject has any other condition that makes them unsuitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
PKUcare Luzhong Hospital
Zibo, Shangdong, 255400
Yan Gao, +86-0571-89918267, cxygaoyan@eastchinapharm.com
About this study
Official title: A Phase I, Single-center, Randomized, Double-blind, Placebo- and Positive-controlled, Four-period, Crossover Clinical Study to Evaluate the Effect of HDM1002 Tablets on Cardiac Repolarization in Healthy Subjects
The aim of this trial is to evaluate the effect of a single oral dose of HDM1002 tablets on the QT/QTc interval in healthy subjects.
- Conditions
- Healthy Adult Subject
- Being tested
- HDM1002 200 mg, HDM1002 400 mg, Placebo, Moxifloxacin 400 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDM1002 200 mgDrug
HDM1002 tablet, oral, 200 mg single dose
HDM1002 400 mgDrug
HDM1002 tablet, oral, 400 mg single dose
PlaceboDrug
Placebo tablet, oral, single dose
Moxifloxacin 400 mgDrug
Moxifloxacin tablet, oral, 400 mg single dose
| Study group | Role | What they receive |
|---|---|---|
| HDM1002 200 mg | Experimental | Not described Receives: Drug: HDM1002 200 mg |
| HDM1002 400 mg | Experimental | Not described Receives: Drug: HDM1002 400 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Moxifloxacin | Active comparator | Not described Receives: Drug: Moxifloxacin 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between HDM1002 Plasma Concentration and ΔΔQTc
HDM1002 plasma concentration in ng/mL measured by validated LC-MS/MS; ΔΔQTc in msec derived from Fridericia-corrected QT interval with baseline and placebo correction, using 12-lead ECG read centrally in a blinded manner.
Measured: From the base line ECG (Day -1) to end of the period, up to 48 hours post-dose
Secondary outcomes (2)
Categorical outliers for QTc, HR, PR, and QRS
QTc, PR, and QRS expressed as msec, HR expressed as beats per minute
Measured: From the base line ECG (Day -1) to end of the period, up to 48 hours post-dose
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Measured: 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start7 Mar 2026
- Primary completion25 Sep 2026 (estimated)
- Study completion6 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult SubjectStudies of the same condition, open and under way.
- More trials run by Hangzhou Zhongmei Huadong Pharmaceutical 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594847
- Sponsor's protocol ID
- HDM1002-110
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-center, Randomized, Double-blind, Placebo- and Positive-controlled, Four-period, Crossover Clinical Study to Evaluate the Effect of HDM1002 Tablets on Cardiac Repolarization in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07594847
- Acronym / sponsor ID
- HDM1002-110
- Conditions
- Healthy Adult Subject
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Mar 2026 (actual)
- Primary completion
- 25 Sep 2026 (estimated)
- Study completion
- 6 Nov 2026 (estimated)
- First posted
- 19 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.
The aim of this trial is to evaluate the effect of a single oral dose of HDM1002 tablets on the QT/QTc interval in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HDM1002 200 mg | Experimental | Drug: HDM1002 200 mg |
| HDM1002 400 mg | Experimental | Drug: HDM1002 400 mg |
| Placebo | Placebo comparator | Drug: Placebo |
| Moxifloxacin | Active comparator | Drug: Moxifloxacin 400 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The subject has voluntarily signed a written informed consent form.
- Male or female; age between 18 and 45 years (inclusive).
- Subject's weight ≥50 kg, with a body mass index (BMI) between 19.0 and 28.0 kg/m2, inclusive. BMI = weight (kg) / height2 (m2).
- Medical history inquiry, physical examination, laboratory test items, and other trial-related tests at screening are all normal or show mild abnormalities with no clinical significance, and the subject is judged to be eligible by the clinical research physician.
- The subject is able to communicate well with the investigator and comply with the protocol requirements to complete the study.
Key exclusion criteria (10 listed)
- History of or current neurological/psychiatric, respiratory, cardiovascular, gastrointestinal, hematological and lymphatic, endocrine, or musculoskeletal system diseases, hepatic or renal insufficiency, or any other disease or physiological condition that may affect the study results;
- Subjects with a personal or family history of medullary thyroid cancer (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2);
- History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening;
- History of a cholecystitis episode within 3 months prior to screening;
- History of allergy to HDM1002, moxifloxacin hydrochloride tablets, other fluoroquinolones or quinolones, or any of the excipients; or history of food allergy, or a specific allergy history (asthma, urticaria, eczema, etc.);
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 |
|---|---|---|
| HDM1002 200 mgHDM1002 tablet, oral, 200 mg single dose | Drug | HDM1002 200 mg |
| HDM1002 400 mgHDM1002 tablet, oral, 400 mg single dose | Drug | HDM1002 400 mg |
| PlaceboPlacebo tablet, oral, single dose | Drug | Placebo |
| Moxifloxacin 400 mgMoxifloxacin tablet, oral, 400 mg single dose | Drug | Moxifloxacin |
Primary outcome
Correlation between HDM1002 Plasma Concentration and ΔΔQTc
Time frame: From the base line ECG (Day -1) to end of the period, up to 48 hours post-dose
HDM1002 plasma concentration in ng/mL measured by validated LC-MS/MS; ΔΔQTc in msec derived from Fridericia-corrected QT interval with baseline and placebo correction, using 12-lead ECG read centrally in a blinded manner.
2 secondary outcomes
Categorical outliers for QTc, HR, PR, and QRS
Time frame: From the base line ECG (Day -1) to end of the period, up to 48 hours post-dose
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 25 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- 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.
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 HDM1002 200 mg, HDM1002 400 mg and Moxifloxacin 400 mg in people with Healthy Adult Subject, run by Hangzhou Zhongmei Huadong Pharmaceutical 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 10 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: looking for participants now, as of the sponsor's last update on 19 May 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between HDM1002 Plasma Concentration and ΔΔQTc (time frame: From the base line ECG (Day -1) to end of the period, up to 48 hours post-dose). 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 19 May 2026.