Study of HS235 for Assessing the Pharmacokinetics, Safety, and Pharmacodynamics in Overweight/Obese Healthy Subjects

A Phase 1 Study Assessing the Pharmacokinetics, Safety, and Pharmacodynamics of HS235 in Overweight and Obese Otherwise Healthy Subjects: Single Ascending Dose (SAD) in Males and Postmenopausal Females and Multiple Ascending Dose (MAD) in Males and Females of Non-childbearing Potential

Inclusion criteria

• Male or female above 40 years of age, inclusive.
• Body Mass Index (BMI) between 28 and 40 kg/m2, inclusive.
• Body weight at or below 140 kg with a stable body weight.
• In good health or with no clinically significant medical conditions
• Females who are post-menopausal or are of Non-child bearing Potential.
• Male subjects must be willing not to donate sperm for 90 days after the last dose.
• Able to understand the study procedures and provide signed informed consent to participate in the study.

Exclusion criteria

• Females with a positive pregnancy test or who are lactating.
• Subjects with diabetes or have previous history of diabetes.
• Subjects who have recently donated blood, plasma and platelets.
• Subjects with history of alcoholism or drug abuse.
• Subjects who received systemic or topical medications, depot injections or implants, hormone replacement, non-prescribed medication or herbal remedies, or daily glucocorticoids for > 1 month in previous year.
• Subjects with clinically significant abnormal pulse or blood pressure or temperature.
• Subjects with a history of a clinically significant medical disorder or lab abnormality.
• Subjects with a significant history of multiple drug allergies, including infusion reactions and hypersensitivity to any of the excipients of HS235.
• Subjects who are carriers of the hepatitis B surface antigen (HBsAg) and are carriers of the hepatitis C antibody (except if Polymerase Chain Reaction Ribonucleic acid (PCR RNA) is negative); or have a positive result to the test for human immunodeficiency virus (HIV) antigen or antibody.
• Subjects who have, in the opinion of the Investigator, an abnormality in the echocardiogram or 12-lead ECG that put them at increased risk during the study.
• Current or history of treatment with medications that may cause significant weight gain or loss, within 3 months or 5 half-lives of screening.
• Obesity induced by other endocrine disorders.
• Previous surgical treatment for obesity.
• Current or history of treatment with medications that may cause significant weight gain or loss.