Overview

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