Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09
- Registration Number
- NCT04354090
- Lead Sponsor
- Beijing Dongfang Biotech Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 0.3-mg JY09 Eligible subjects received 0.3 mg placebo or JY09 on day 1 in this cohort Cohort 0.7-mg JY09 Eligible subjects received 0.3 mg placebo or JY09 on days 1, and 0.7 mg placebo or JY09 on days 22 Cohort 1.5-mg JY09 Eligible subjects received 0.7 mg placebo or JY09 on days 1, and 1.5 mg placebo or JY09 on days 22 Cohort 3.0-mg JY09 Eligible subjects received 0.7 mg placebo or JY09 on days 1, and 3.0 mg placebo or JY09 on days 22 Cohort 6.0-mg JY09 Eligible subjects received 0.7 mg placebo or JY09 on days 1, and 1.0 mg placebo or JY09 on days 15, and 6.0 mg placebo or JY09 on days 30
- Primary Outcome Measures
Name Time Method Incidence of adverse events and serious adverse events related to JY09 Up to day 21
- Secondary Outcome Measures
Name Time Method Pharmacodynamics parameters: Cmax Up To day 42 Average Cmax of each dose level
Pharmacodynamics parameters: AUC Up to day 42 Average AUC follewing single dose of each doase level
Immunogenicity Up To day 42 Anti-JY09 antibody incidence at each dose level
Pharmacodynamics parameters: Half-life Up to day 42 Average Half-life of each dose level
Pharmacokinetics parameters Day 5 OGTT test was conducter predose and 5 days after the target dose in each cohorts
Trial Locations
- Locations (1)
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China