This trial adopts a single-center, randomized, double-blind, placebo-controlled, dose-escalation design to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HEC-007 Injection after single-dose administration in healthy subjects and multiple-dose administration in overweight or obese subjects.
The trial consists of two parts: Part A is a single ascending dose (SAD) study, planning to enroll 54 Chinese healthy subjects; Part B is a multiple ascending dose (MAD) study, planning to enroll 72 Chinese overweight or obese subjects.
Subjects understand and comply with the study procedures, voluntarily participate, and sign the informed consent form.
Healthy adult subjects (including borderline values) aged 18 to 45 years, regardless of sex.
Male subjects weigh no less than 50 kg, and female subjects weigh no less than 45 kg. BMI =Body weight (kg)/height2 (m2), with a body mass index ranging from 19.0 to 35.0 kg/m2 (including boundary values).
Normal results or abnormalities deemed clinically insignificant by the investigator in vital signs, physical examination, laboratory tests, electrocardiogram, chest CT, abdominal ultrasound (liver, gallbladder, spleen, pancreas, and both kidneys), and thyroid ultrasound.
Those diagnosed with type 1, type 2, or other types of diabetes before screening;
History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia syndrome type 2 (MEN2) during screening, or genetic predisposition to MTC;
Acute, chronic, or suspected pancreatitis during screening, or prior pancreatectomy;
Those diagnosed with any malignancy within 5 years before screening (except for basal cell carcinoma treated curatively and considered cured);