Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09

Summary

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.

Timeline

Start

2018-04-26

Primary completion

2018-12-27

Completion

2019-06-22

Drugs

Indications