JY09 is a glucagon-like peptide-1 (GLP-1) mimetic generated by genetic fusion of a Exendin-4 dimer to human immunoglobulin Fc. In this Double-blind, randomized, placebo-controlled trial, 41 healthy subjects received placebo or escalating doses of JY09 on day 1 in the first cohort, and on days 1 and 22 in the following sequential cohort 2-4, and on days 1, 15, and 30 in the cohort 5: cohort 1: 0.3 mg; cohort 2: 0.3 + 0.7 mg; cohort 3: 0.7+1.5 mg; cohort 4: 0.7+3.0 mg; and cohort 5: 0.7 + 1.5 + 6.0 mg. The primary endpoints were the incidence of adverse events and serious adverse events related to JY09. Secondary endpoints included pharmacodynamics and pharmacokinetics parameters, as well as anti-JY09 antibody incidence and titers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
41
Subcutaneous injection
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Incidence of adverse events and serious adverse events related to JY09
Time frame: Up to day 21
Pharmacodynamics parameters: Cmax
Average Cmax of each dose level
Time frame: Up To day 42
Pharmacodynamics parameters: AUC
Average AUC follewing single dose of each doase level
Time frame: Up to day 42
Pharmacodynamics parameters: Half-life
Average Half-life of each dose level
Time frame: Up to day 42
Pharmacokinetics parameters
OGTT test was conducter predose and 5 days after the target dose in each cohorts
Time frame: Day 5
Immunogenicity
Anti-JY09 antibody incidence at each dose level
Time frame: Up To day 42
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