Healthy Adult SubjectPhase 1NCT06608329
A Relative Bioavailability and Food Effect Study of HDM1002 in Healthy Subjects
A Phase 1 study testing HDM1002 in people with Healthy Adult Subject, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The main purpose of this study is to evaluate the effect of formulation on relative bioavailability of HDM1002, and the food effect on pharmacokinetics of HDM1002. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- Oct 2024to Dec 2024
- 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
- According to the medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination results during the screening period, the investigator considers the subject to be in good general health.
- Age range of 18-45 years old (including range), no limit to gender.
- Male subject weighed ≥50.0 kg, female subject weighed ≥45.0 kg, and a body mass index (BMI) within the range of 19.0 - 30.0 kg/m2 (including cut-off values).
- Female subject of childbearing potentiaafter last dose, who have no childbearing plans and agrl during signature ICF to 30 days after last dose and male subject during signature ICF to 90 days ee to use highly effective contraception and consent not to donate sperm and oocyte during this period.
Who cannot join
- Subject has a history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin≥50 ng/L during the screening period.
- History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
- History of acute cholecystitis attack within 3 months prior to screening.
- Subject judged by investigator has dysphagia, diseases or conditions that affect gastric emptying, or affect the absorption of gastrointestinal nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.
- History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period.
- During screening period, any abnormalities in physical examination, electrocardiogram, laboratory tests, and vital signs which are of clinically significant .
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- Taken or planned to take any drug that effect liver enzyme or transporter activity within 28 days prior to taking the investigational drug.
- History of clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening or at the time of admission.
- Presence of clinically significant ECG results judged by the investigator at screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Crossover Study to Evaluate Relative Bioavailability, and Food Effect of HDM1002 in Healthy Subjects
The main purpose of this study is to evaluate the effect of formulation on relative bioavailability of HDM1002, and the food effect on pharmacokinetics of HDM1002.
- Conditions
- Healthy Adult Subject
- Being tested
- HDM1002
- Keywords
- HDM1002 tablet, Glucagon-Like Peptide-1 Receptor Agonists
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDM1002Drug
Single dose, administered orally. The study is a randomized, open-label, single dose, 3-period, 3 sequence, crossover design.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Period 1: Subjects received HDM1002 table (200 mg×1）in fasted state; Period 2: Subjects received HDM1002 tables (100 mg×2）in fasted state; Period 3: Subjects received HDM1002 table (200 mg×1）in fed state. Receives: Drug: HDM1002 |
| Cohort 2 | Experimental | Period 1: Subjects received HDM1002 tables (100 mg×2）in fasted state; Period 2: Subjects received HDM1002 table (200 mg×1）in fed state; Period 3: Subjects received HDM1002 table (200 mg×1）in fasted state. Receives: Drug: HDM1002 |
| Cohort 3 | Experimental | Period 1: Subjects received HDM1002 table (200 mg×1）in fed state; Period 2: Subjects received HDM1002 table (200 mg×1）in fasted state; Period 3: Subjects received HDM1002 tables (100 mg×2）in fasted state. Receives: Drug: HDM1002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC[0-∞]
Area under the curve from time 0 hour to ∞
Measured: Day1-Day17
AUC[0-t]
Area under the curve from time 0 to t hour
Measured: Day1-Day17
Cmax
Maximum observed concentration
Measured: Day1-Day17
Tmax
Time to maximum plasma concentration
Measured: Day1-Day17
t1/2
Half life
Measured: Day1-Day17
CL/F
Apparent Clearance
Measured: Day1-Day17
Vz/F
Apparent volume of distribution
Measured: Day1-Day17
F
Relative Bioavailability
Measured: Day1-Day17
Secondary outcomes (1)
Adverse events (AEs)
Number of subjects reporting AEs
Measured: Day1-Day17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (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
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608329
- Sponsor's protocol ID
- HDM1002-108
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 23 Sep 2024
- 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 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Crossover Study to Evaluate Relative Bioavailability, and Food Effect of HDM1002 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06608329
- Acronym / sponsor ID
- HDM1002-108
- Conditions
- Healthy Adult Subject
- Keywords
- HDM1002 tablet, Glucagon-Like Peptide-1 Receptor Agonists
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 Sep 2024 (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 main purpose of this study is to evaluate the effect of formulation on relative bioavailability of HDM1002, and the food effect on pharmacokinetics of HDM1002.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: HDM1002Period 1: Subjects received HDM1002 table (200 mg×1）in fasted state; Period 2: Subjects received HDM1002 tables (100 mg×2）in fasted state; Period 3: Subjects received HDM1002 table (200 mg×1）in fed state. |
| Cohort 2 | Experimental | Drug: HDM1002Period 1: Subjects received HDM1002 tables (100 mg×2）in fasted state; Period 2: Subjects received HDM1002 table (200 mg×1）in fed state; Period 3: Subjects received HDM1002 table (200 mg×1）in fasted state. |
| Cohort 3 | Experimental | Drug: HDM1002Period 1: Subjects received HDM1002 table (200 mg×1）in fed state; Period 2: Subjects received HDM1002 table (200 mg×1）in fasted state; Period 3: Subjects received HDM1002 tables (100 mg×2）in fasted state. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- According to the medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination results during the screening period, the investigator considers the subject to be in good general health.
- Age range of 18-45 years old (including range), no limit to gender.
- Male subject weighed ≥50.0 kg, female subject weighed ≥45.0 kg, and a body mass index (BMI) within the range of 19.0 - 30.0 kg/m2 (including cut-off values).
- Female subject of childbearing potentiaafter last dose, who have no childbearing plans and agrl during signature ICF to 30 days after last dose and male subject during signature ICF to 90 days ee to use highly effective contraception and consent not to donate sperm and oocyte during this period.
Key exclusion criteria (9 listed)
- Subject has a history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin≥50 ng/L during the screening period.
- History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
- History of acute cholecystitis attack within 3 months prior to screening.
- Subject judged by investigator has dysphagia, diseases or conditions that affect gastric emptying, or affect the absorption of gastrointestinal nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.
- History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period.
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 |
|---|---|---|
| HDM1002Single dose, administered orally. The study is a randomized, open-label, single dose, 3-period, 3 sequence, crossover design. | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
AUC[0-∞]
Time frame: Day1-Day17
Area under the curve from time 0 hour to ∞
AUC[0-t]
Time frame: Day1-Day17
Area under the curve from time 0 to t hour
Cmax
Time frame: Day1-Day17
Maximum observed concentration
Tmax
Time frame: Day1-Day17
Time to maximum plasma concentration
t1/2
Time frame: Day1-Day17
Half life
CL/F
Time frame: Day1-Day17
Apparent Clearance
Vz/F
Time frame: Day1-Day17
Apparent volume of distribution
F
Time frame: Day1-Day17
Relative Bioavailability
1 secondary outcome
Adverse events (AEs)
Time frame: Day1-Day17
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
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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.
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 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 23 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Wang (+86-18367124548, nancywangying@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC[0-∞] (time frame: Day1-Day17). The study lists 8 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 23 Sep 2024.