Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09

Beijing Dongfang Biotech

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: JY09

Study type: Interventional

Funder types: Industry

Identifiers

NCT04354090

DFBT-JY09-101a

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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41 participants in 5 patient groups

Cohort 0.3-mg

Experimental group

Description:

Eligible subjects received 0.3 mg placebo or JY09 on day 1 in this cohort

Treatment:

Drug: JY09

Cohort 0.7-mg

Experimental group

Description:

Eligible subjects received 0.3 mg placebo or JY09 on days 1, and 0.7 mg placebo or JY09 on days 22

Treatment:

Drug: JY09

Cohort 1.5-mg

Experimental group

Description:

Eligible subjects received 0.7 mg placebo or JY09 on days 1, and 1.5 mg placebo or JY09 on days 22

Treatment:

Drug: JY09

Cohort 3.0-mg

Experimental group

Description:

Eligible subjects received 0.7 mg placebo or JY09 on days 1, and 3.0 mg placebo or JY09 on days 22

Treatment:

Drug: JY09

Cohort 6.0-mg

Experimental group

Description:

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

Treatment:

Drug: JY09