The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of LAE102 injection in healthy and overweight/obese participants, and also evaluate the preliminary pharmacodynamic effect of multiple dose injections in overweight/obese participants.
Part A is a randomized, double-blinded, placebo-controlled, single ascending dose by Intravenous (IV) administration in 40 Healthy participants; Part B is a randomized, double-blinded, placebo-controlled, single ascending dose by subcutaneous (SC) administration in 24 Healthy participants; Part C is a randomized, double-blind, placebo-controlled, multiple dose ascending and expanding by subcutaneous (SC) administration in 60 overweight/obese participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
A single dose of LAE102 administered intravenously
A single dose of placebo administered intravenously
Single dose of LAE102 administered subcutaneously
Fudan Zhongshan Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGNumber & severity of participants with treatment-related adverse events as assessed by CTCAE V5.0
Findings on physical examination, ECG, vital signs, and reports of the laboratory results based on the CTCAE v5.0
Time frame: From Day 1 to Day 29 for single dose part. From Day 1 to Day 196 for multiple dose part
characterize the peak of serum concentration (Cmax) of LAE102 injection in healthy subjects
For both intravenously guttae \& subcutaneous injection, to evaluate the maximum observed serum concentration(Cmax)
Time frame: From pre-dose to Day 29 for single dose part. From pre-dose to Day 196 for multiple dose part.
characterize the area under the serum concentration versus time curve (AUC) of LAE102 injection in healthy subjects
For both intravenously guttae \& subcutaneous injection, to evaluate the area under the serum concentration versus time curve (AUC)
Time frame: From pre-dose to Day 29 for single dose part. From pre-dose to Day 196 for multiple dose part.
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.
Time frame: From pre-dose to Day 29 for single dose part. From pre-dose to Day 196 for multiple dose part.
Incidence of positive Anti-drug antibody(ADA) after administration
Test ADA status in biological sample via validated methodology
Time frame: pre-dose to Day 29 for single dose part. From pre-dose to Day 196 for multiple dose part.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
single dose of placebo administered subcutaneously
Multiple dose of LAE102 administered subcutaneously
Multiple dose of placebo administered subcutaneously