Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09

NCT04354090 · Completed

Last updated 2026-05-28

This clinical trial is testing the safety and tolerability of the experimental drug JY09 in adults with type 2 diabetes.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, double-blind study

Participants 41 people

Who can join Ages 18–45 · all sexes Healthy volunteers accepted.

Timeline Started 2018-04 · est. completion 2019-06

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT04354090 ↗

Description as written by the study sponsor.

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.

Treatments tested

JY09 also known as Placebo Drug

Subcutaneous injection

Main thing measured	Incidence of adverse events and serious adverse events related to JY09
Sponsor	Beijing Dongfang Biotech Co., Ltd.
Conditions studied	Diabetes Mellitus, Type 2
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04354090 ↗