ClinicalTrials.Veeva

Menu

Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09

B

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

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems