Not Yet RecruitingPhase 1

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

China33 participantsStarted 2024-10

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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 .
✕. 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.

What they're measuring

AUC[0-∞]

Timeframe: Day1-Day17

AUC[0-t]

Timeframe: Day1-Day17

Cmax

Timeframe: Day1-Day17

Tmax

Timeframe: Day1-Day17

t1/2

Timeframe: Day1-Day17

CL/F

Timeframe: Day1-Day17

Vz/F

Timeframe: Day1-Day17

Trial details

NCT IDNCT06608329

SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11

Contact for this trial

Ying Wang

+86-18367124548 nancywangying@163.com

View on ClinicalTrials.gov More Healthy Adult Subject trials

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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 .
✕. 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.