A Phase I, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LAE103 as Single and Multiple Ascending Doses in Healthy Overweight/Obese Participants, and as Single Dose in Healthy Postmenopausal Women, With an Additional Evaluation of Single Ascending Dose of LAE103 in Combination With LAE102 in Healthy Overweight/Obese Participants
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of LAE103 injection in healthy overweight/obese participants or healthy postmenopausal women. Study will also evaluate the safety, tolerability and preliminary pharmacodynamic effect of multiple dose injections in overweight/obese participants. In addition, the study will also investigate the safety, tolerability of a single-dose co-administration of LAE102 and LAE103 in healthy overweight/obese participants.
• Are capable of giving signed informed consent and comply with the requirements and restrictions listed in the ICF and in this protocol.
• Male or female participants aged 18 to 55 years in part A, C, D. Female participants aged 45 to 75 years in Part B.
• Have a BMI within the range of 25.0 to 40.0 kg/m2 in Parts A, C, and D and a BMI within the range of 20.0 to 35.0 kg/m2 in Part B.
• Participants without childbearing potential or Participants with childbearing potential, non-pregnant, non-lactating, must agree to use two forms of effective methods of contraception (at least one form must be highly effective) .
• Male participants with female partners of childbearing potential must agree to use adequate methods of contraception. Male subjects are not allowed to donate sperm during this trial.
• Are overtly healthy participants or Have FSH levels ≥ 40 IU/L at screening (Part B only).
• Are willing to make themselves available for study visits for the duration of the study and are willing to follow study procedures.