Phase 1 study for people with Obesity

Reproduced exactly, unedited. Written for researchers rather than for patients.

Inclusion Criteria:

1. Fully understand the content, process and possible adverse drug reactions (ADRs) of the study before the study, and voluntarily sign the ICF;
2. At Screening, aged 18 to 60 years (inclusive, based on the date of signing the ICF), including both males and females;
3. At Screening, body weight ≥ 50 kg with a body mass index (BMI) of 18 to 35 kg/m²
4. Body weight change ≤ 5% within 3 months prior to Screening (including the Screening Period) (based on participant self-report);
5. Participants (including their partners) have no birth plan from signing the ICF until 6 months after the last dose, and agree to use highly effective contraceptive measures as stipulated in the protocol.

Exclusion Criteria:

1. Known or suspected allergy to amylin receptor agonists or any component of the investigational product; or those with an allergic constitution (allergy to multiple drugs and foods);
2. Clinically significant abnormal results in vital signs, physical examination, laboratory tests, or ECG, as judged by the Investigator, that render the participant unsuitable for the study. The following conditions do not lead to exclusion: (1) TG ≤ 3.42 mmol/L, TC ≤ 7.5 mmol/L, HDL-C abnormal; (2) alanine aminotransferase (ALT) < 1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) < 1.5 × ULN, or total bilirubin <1.5 × ULN;
3. HbA1c ≥ 6.5% during Screening Period, or fasting glucose < 3.9 mmol/L or ≥ 7 mmol/L;
4. Prolonged QTcF interval during Screening Period (≥ 450 ms for males; ≥ 460 ms for females; see Section 13.5 for calculation formula), history of risk factors for Torsades de Pointes (e.g., cardiac failure/cardiomyopathy, or family history of long QT syndrome);
5. Positive for any of the following: Hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema antibody.
6. Significant history or clinical manifestation of any metabolic, dermatological, hepatic, renal, hematological, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, immune or psychiatric disorder that, in the opinion of the Investigator, may place the participant at increased risk or interfere with study assessments. This does not include: resolved childhood asthma; mild intermittent asthma; seasonal allergic rhinitis; eczema with no use of topical steroid creams within 3 months prior to Screening; fully resolved gestational diabetes; or Gilbert's syndrome;
7. Severe trauma or major surgery within 3 months prior to Screening, or plan to undergo surgery during the study; 8）History of malignancy (not including basal cell carcinoma [BCC], squamous cell carcinoma [SCC], or carcinoma in situ of the cervix); history of severe/major depressive/anxiety (not including history of mild/resolved depressive/anxiety, as judged by the Investigator); or epilepsy (not including a history of febrile seizures in childhood);

9) History of clinical gastric emptying abnormalities (e.g., gastric outlet obstruction) or severe chronic gastrointestinal diseases (e.g., inflammatory bowel disease, active ulcers); history of acute or chronic pancreatitis; or active/current gallbladder disease (e.g., symptomatic cholelithiasis, cholecystitis). This does not include a history of cholecystectomy for resolved gallbladder disease; 10) History of gastrointestinal surgery that may lead to malabsorption, or long-term use of drugs directly affecting gastrointestinal motility, or other therapies that affect gastrointestinal motility. Examples include: bariatric surgery or procedures (e.g., gastric banding), or use of glucagon-like peptide-1 (GLP-1) receptor agonist, glucose-dependent insulinotropic polypeptide (GIP) receptor agonist, amylin receptor agonists, or drugs/products deemed by the Investigator to cause body weight changes and affect body weight assessment within 3 months prior to Screening (see Section 6.8 for details); This does not include appendectomy or uncomplicated hernia repair, which are permitted; 11) Presence of symptoms or signs of dermatitis or skin abnormalities (including tattoos) at or around the injection site (abdomen), or within 5 cm of the injection site; 12) Use of any prescription drugs within 14 days prior to dosing, or less than 5 half-lives have elapsed since the last use (whichever is longer), with the exception of hormonal contraceptives used for contraceptive purposes as permitted under Section 13.1.2; Use of any over-the-counter (OTC) drugs (excluding topical medications such as creams, ointments, or eye drops), dietary supplements, or herbal medicines within 7 days prior to dosing, or less than 5 half-lives have elapsed since the last use (whichever is longer), except for short-term use of paracetamol and anti-inflammatory drugs within 7 days prior to dosing, at the Investigator's discretion; 13）Use of drugs that may affect glucose metabolism (e.g., systemic steroids, non-selective beta-blockers, monoamine oxidase inhibitors) within 1 month prior to Screening, or less than 5 half-lives have elapsed since the last use of such drugs (whichever is longer); 14) Average weekly alcohol consumption exceeding 21 units (males) or 14 units (females) within 3 months prior to Screening (1 unit ≈ 360 mL of beer with 5% alcohol content, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine with 12% alcohol content), positive breath alcohol test, or inability to abstain from alcohol during the study; 15）Participants who smoked > 10 cigarettes/week or 2 cigarettes/day (or nicotine-equivalent, including e-cigarettes/vaping devices) within 3 months prior to Screening or who cannot stop using any nicotine products (including cigarettes, e-cigarettes/vaping devices, smokeless tobacco, and nicotine replacement therapy) during the study. A positive cotinine result, or the need for repeat testing, may be permitted at the Investigator's discretion; 16) Average daily consumption of excessive tea, coffee, and/or caffeine-containing beverages (more than 8 cups on average, 1 cup ≈ 250 mL) within 3 months prior to Screening, or inability to abstain during the study; 17) Strenuous exercise (e.g., weightlifting, sprinting, long-distance running, cycling, swimming, soccer) within 48 h prior to Screening; 18) History of drug abuse within 3 months prior to Screening, or positive drug abuse screening test. A positive drug abuse screening test result attributable to a documented medical history of prescribed medication may be permitted at the Investigator's discretion, following discussion with the Sponsor, provided the participant is not currently receiving such medication; 19) Has donated whole blood or had a loss of whole blood of more than 500 mL within the 30 days prior to Screening; has donated plasma (plasmapheresis) within 7 days prior to Screening; or has received a blood transfusion within one year prior to Screening; Participants with a history of needle phobia and blood phobia, difficulty in blood collection or intolerance to venipuncture blood collection; 21) Participants who had special dietary requirements and could not accept a uniform diet and rest. The following dietary requirements will be accommodated: dairy/lactose-free, gluten-free, gluten-free and lactose-free, halal, no pork and beef, no red meat, no seafood, pescatarian, standard, vegan, and vegetarian; 22) Females who are pregnant, lactating, or have a positive serum pregnancy test during the Screening Period; 23) Participation in any other clinical study of drugs or medical devices within 3 months or 5 half-lives prior to Screening (whichever is longer), or planned participation in a clinical study of other drugs or medical devices during this study; 24) Participants whom the Investigator judges to have other factors that make them unsuitable to participate in the trial.