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Clinical Trials in China / NCT06608329
Starting soon Phase 1

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

NCT06608329 · tracked via the Priya Life Science China tracker
Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Phase
Phase 1
Started
2024-10
Last updated
2024-09-23

Condition(s) studied

Healthy Adult Subject

Investigational drug(s) / intervention(s)

HDM1002 →

HDM1002: Single dose, administered orally. The study is a randomized, open-label, single dose, 3-period, 3 sequence, crossover design.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hangzhou First People's Hospital Hangzhou Zhejiang

More Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06608329 on ClinicalTrials.gov ↗ ← All trials in China