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Not yet recruitingPhase 1

A Relative Bioavailability and Food Effect Study of HDM1002 in Healthy Subjects

A Randomized, Open-label, Crossover Study to Evaluate Relative Bioavailability, and Food Effect of HDM1002 in Healthy Subjects

Asset

HDM1002

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

33

estimated

Study population

Healthy volunteers

Key I/E criterion

BMI 19-30

Primary endpoints

AUC[0-∞]AUC[0-t]Cmax

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06608329
Org study IDHDM1002-108

Timeline

Milestones

Study first posted2024-09-23actual
Last update posted2024-09-23actual
Study start2024-10estimated (month precision)
Primary completion2024-11estimated (month precision)
Study completion2024-12estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

1. 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.

2. Age range of 18-45 years old (including range), no limit to gender.

3. 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).

4. 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.

Exclusion criteria

1. 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.

2. History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.

3. History of acute cholecystitis attack within 3 months prior to screening.

4. 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.

5. History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period.

6. During screening period, any abnormalities in physical examination, electrocardiogram, laboratory tests, and vital signs which are of clinically significant .

7. Taken or planned to take any drug that effect liver enzyme or transporter activity within 28 days prior to taking the investigational drug.

8. History of clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening or at the time of admission.

9. Presence of clinically significant ECG results judged by the investigator at screening.

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

9 endpoints
Primary/protocol endpoint

AUC[0-∞]

Time frame:Day1-Day17

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

AUC[0-t]

Time frame:Day1-Day17

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Cmax

Time frame:Day1-Day17

Cmax

concentration, descriptive

Primary/protocol endpoint

Tmax

Time frame:Day1-Day17

Tmax

descriptive

Primary/protocol endpoint

t1/2

Time frame:Day1-Day17

Half-life

descriptive

Primary/protocol endpoint

CL/F

Time frame:Day1-Day17

descriptive

Primary/protocol endpoint

Vz/F

Time frame:Day1-Day17

descriptive

Primary/protocol endpoint

F

Time frame:Day1-Day17

descriptive

Secondary/protocol endpoint

Adverse events (AEs)

Time frame:Day1-Day17

Treatment-emergent AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.