Healthy Participants, Overweight and/or Obesity
Conditions
Brief summary
The purpose of this study is to evaluate the relative bioavailability of a single subcutaneous injection of HDM1005 solution at different injection sites (upper arm and thigh)by using the abdomen subcutaneous injection as a control.
Interventions
DRUGHDM1005
2.0 mg, SC, single dose
Sponsors
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged between 18 and 55 years (inclusive), regardless of gender. * Body weight ≥50.0 kg for males and ≥45.0 kg for females; body mass index (BMI) between 19.0 and 35.0 kg/m² (inclusive). * In the investigator's opinion, the participants do not have any clinically significant abnormal findings based on medical history, clinical laboratory tests, vital signs, 12-lead ECG, and physical examination at screening. * Provide signed informed consent before any trial procedures; fully understand the trial content, procedures, and possible adverse reactions.
Exclusion criteria
* Personal or family history of medullary thyroid carcinoma (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 acute cholecystitis within 3 months prior to screening. * Severe hypoglycemic events or recurrent hypoglycemic events (≥3 episodes per week) within 3 months prior to screening. * Presence of clinically significant diseases involving any of the following systems at screening (including but not limited to respiratory, circulatory, digestive, hematopoietic, endocrine, immune, skin, nervous, psychiatric, ear-nose-throat, etc.), which in the investigator's opinion make the participant unsuitable. * History of specific allergy (such as asthma, urticaria, eczema, etc.) or allergic constitution; or known intolerance or allergy to any component of the investigational drug or GLP-1 receptor (GLP-1R) agonists; or have a history of severe drug allergies. * Major surgery within 6 months prior to screening, or incomplete healing of surgical incisions, or planned surgery during the study. * Blood donation or blood loss ≥400 mL, or use of blood products within 3 months prior to screening or between screening and dosing. * History of drug abuse or positive urine drug test at screening. * Use of prescription or over-the-counter medications, health supplements, or herbal medicines within 2 weeks prior to IMP administration, or still within 5 half-lives of such medications. * Participation in any clinical trial and use of investigational product within 3 months prior to screening, or still within 5 half-lives of the investigational product from a previous trial at the time of screening (whichever is longer). * Female participants who are breastfeeding or pregnant. * History of needle phobia or hemophobia, difficulty with blood collection, or inability to tolerate venipuncture. * Any other condition (medical, psychological, psychiatric, social, or geographic factors) that, in the investigator's opinion, makes the participant unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Up to Day 29 | Maximum observed concentration |
| AUC(0-t) | Up to Day 29 | Area under the curve from time 0 to t hour |
| AUC(0-∞) | Up to Day 29 | Area under the curve from time 0 hour to ∞ |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax | Up to Day 29 | Time to maximum plasma concentration |
| t1/2 | Up to Day 29 | Half life |
| CL/F | Up to Day 29 | Apparent Clearance |
| Vz/F | Up to Day 29 | Apparent volume of distribution |
| Adverse events (AEs) | Up to Day 29 | Number of subjects reporting AEs |
Countries
China
Outcome results
None listed