A Study to Evaluate a Single Dose of IBIO-610 in Participant With Obesity.

Ki vehet részt

• Aged 18 to 65 years (inclusive) at the time of informed consent
• In good general health, with no significant history and/or uncontrolled medical condition
• BMI between ≥ 30.0 and ≤ 45.0 kg/m2
• Able to fit in the DEXA and MRI scanners field of view in order to ensure adequate coverage and image acquisition
• Must agree to refrain from any reconstructive and/or cosmetic surgery and/or noninvasive cosmetic procedure that may affect body weight during the study
• Must be fully ambulatory without any chronic orthopedic diseases or reliance on crutches, walkers, or a wheelchair that may preclude normal activity
• Nonsmoker/nonvaper and must not have used any nicotine or synthetic type products within 1 month prior to randomization
• Not pregnant or breastfeeding from the start of Screening until study completion
• Woman of childbearing potential (WOCBP) or fertile man (see definitions in Section 5.3) who agrees to use an acceptable method of contraception from the start of Screening until study completion, or for a minimum of 9 months following the last dose of IP, whichever period is longer

Ki nem vehet részt

• History or presence of clinically significant skeletal muscle disease, including muscular dystrophy, inflammatory myopathy, or other clinically significant myopathy, or receipt of any procedure or treatment expected to materially affect skeletal muscle mass, regional body composition, or interpretation of study assessments within 6 months prior to randomization or planned from Screening through the end of study
• History of major trauma or major surgery (i.e., surgeries that requires any type of anesthesia other than only local and/or topical) within 3 months prior to randomization or planned major surgery at any time during study participation
• Underlying physical or psychological medical condition that, in the opinion of the PI or medical designee, would make the participant unlikely to comply with the protocol or complete the study per protocol
• History of acute or chronic pancreatitis, symptomatic gallbladder disease, or pancreatic injury, which is considered significant in the opinion of the Investigator
• History of or active cardiovascular disease including clinically significant arrhythmias, Class I-IV heart failure, coronary artery disease, thromboembolic event, or pulmonary hypertension
• History of or active chronic kidney disease
• History or presence of clinically significant liver disease,
• Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus (HIV)-1/2 antibody
• History of malignancy within 5 years prior to randomization, except for adequately treated basal cell or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, or other localized carcinoma in situ that has been definitively treated, with no evidence of recurrence and no requirement for ongoing anticancer therapy
• History of substance abuse or dependency, or recreational IV drug use within the past 12 months
• History or presence of clinically significant liver disease, including cirrhosis, hepatic decompensation, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, or other acute or chronic liver disease that, in the opinion of the Investigator, could affect participant safety or the interpretation of study assessments
• History of diabetes (Type 1 or 2), clinical evidence of diabetes (Hemoglobin A1C [HbA1c] ≥ 6.5%)
• History of insulinoma or recurrent hypoglycemia (≥ 3 episodes in past 3 months), or any documented blood glucose < 2.8 mmol/L within 1 year prior to randomization
• Clinically significant laboratory abnormalities that would preclude participation in the study
• Abnormal ECG findings at Screening
• Pregnant or nursing (lactating) women