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) .
Have a history or presence of clinically significant medical condition(s).
Have a history of any malignancy within the past 5 years. other than basal cell or squamous epithelial carcinomas in situ and cervical carcinoma in situ that have been resected with no evidence of metastatic diseases for 3 years.
Have a fasting serum triglyceride level of more than 500 mg/dL(5.6 mmol/L) at screening.
Estimated glomerular filtration rate (eGFR) less than 90 mL/min/1.73 m2 at screening for Part A, C, and Part D or less than 60 mL/min/1.73 m2 at screening for Part B.
Parallel
LAE103 injection
Drugsubcutaneous injection of LAE103 alone
LAE102 injection in combined with LAE103 injection
DrugLAE102 injection in combined with LAE103 injection via subcutaneous
Saline
DrugSaline via subcutaneous
Number & severity of participants with treatment-related adverse events
Findings on physical examination, ECG, vital signs, and reports of the laboratory results via investigator assessment
characterize the peak of serum concentration (Cmax)
evaluate the maximum observed serum concentration(Cmax) via LAE103 injection mono or LAE102 combined with LAE103 injection
characterize the time of reaching peak of serum concentration (Tmax)
evaluate what time to reach the maximum serum concentration(Tmax)
characterize the area under the serum concentration versus time curve (AUC)
Evaluate the area under the serum concentration versus time curve (AUC) in LAE103 mono injection or LAE102 combined with LAE103 injection
Evaluate the expression levels of Activin A in blood samples
The validated methodology was employed to assay serum levels of Activin A in biological samples.
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