A Pharmacokinetic Study of HDM1005 Injection at Different Injection Sites

Korábbi kezelés

• 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.
• 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.
• 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).

Más betegség

• Personal or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).
• 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 drug abuse or positive urine drug test at screening.
• 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.

Egyéb

• Female participants who are breastfeeding or pregnant.

• 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.