Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
NCT Number: NCT04354090
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.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Nanjing, Jiangsu, 210008, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subcutaneous injection
Other names: Placebo
Time frame: Up to day 21
Time frame: Up To day 42
Average Cmax of each dose level
Time frame: Up to day 42
Average AUC follewing single dose of each doase level
Time frame: Up to day 42
Average Half-life of each dose level
Time frame: Day 5
OGTT test was conducter predose and 5 days after the target dose in each cohorts
Time frame: Up To day 42
Anti-JY09 antibody incidence at each dose level
Beijing Dongfang Biotech Co., Ltd.
Industry
Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09, a Long-acting Glucagon-like Peptide-1 Mimetic, in Healthy Subjects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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