Clinical trial NCT04354090: Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09
Official title: Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09, a Long-acting Glucagon-like Peptide-1 Mimetic, in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Beijing Dongfang Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-04-21
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Male's mass is ≥50 kg, female's mass is ≥45 kg, have a body mass index between 18 and 26 kg/m\^2
* Subjects or their legal representative signed informed consent
* agree to use instruments of contraception from the time of the first dose until 6 months after the last dose of investigational drug, avoid pregnancy make yourself or your mate
* Able to keep good communication with investigator and comply with the requirements of the clinical trials

Exclusion Criteria:

* Smokers,quitting time less than 3 months , or can't quit smoking during the trial
* Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing,or being treated for a direct lower gastrointestinal or using steroids
* Participation in any clinical investigation within 3 months prior to dosing
* Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing
* Significant illness within 2 weeks prior to dosing,and investigator judge doesn't fit to participate in this trial
* A history of clinical significance of abnormal ECG
* A history of diabetes, hyperuricemia and hyperlipidemia
* A history of acute or chronic bronchial spasms
* Have clinical significant gastrointestinal diseases
* Have serious, progressive, or uncontrolled organ or system diseases
* Abuse of drug or alcohol within 12 months before first dosing
* People who are pregnant, nursing mothers, or in the near future plan to be pregnant,or show pregnancy test positive before into group
* Subjects who, in the opinion of the investigator, are in any way unsuitable to participate in the study

Primary outcomes:
measure: Incidence of adverse events and serious adverse events related to JY09
timeFrame: Up to day 21
Secondary outcomes:
measure: Pharmacodynamics parameters: Cmax
timeFrame: Up To day 42
measure: Pharmacodynamics parameters: AUC
timeFrame: Up to day 42
measure: Pharmacodynamics parameters: Half-life
timeFrame: Up to day 42
measure: Pharmacokinetics parameters
timeFrame: Day 5
measure: Immunogenicity
timeFrame: Up To day 42
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Juan Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: