Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09, a Long-acting Glucagon-like Peptide-1 Mimetic, in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04354090
• Other study ID #: DFBT-JY09-101a
• Status: Completed
• Phase: Phase 1
• Start date: April 26, 2018
• Est. completion date: June 22, 2019

Study information

• Verified date: April 2020
• Source: Beijing Dongfang Biotech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 22, 2019
• Est. primary completion date: December 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• JY09
Subcutaneous injection

Locations

Country	Name	City	State
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Dongfang Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events and serious adverse events related to JY09		Up to day 21
Secondary	Pharmacodynamics parameters: Cmax	Average Cmax of each dose level	Up To day 42
Secondary	Pharmacodynamics parameters: AUC	Average AUC follewing single dose of each doase level	Up to day 42
Secondary	Pharmacodynamics parameters: Half-life	Average Half-life of each dose level	Up to day 42
Secondary	Pharmacokinetics parameters	OGTT test was conducter predose and 5 days after the target dose in each cohorts	Day 5
Secondary	Immunogenicity	Anti-JY09 antibody incidence at each dose level	Up To day 42