Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09

• Status: Completed
• Trial end date: 2019-06-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Beijing Dongfang Biotech Co., Ltd.

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