Diabetes Mellitus, Type 2Phase 1NCT04354090
Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09
A Phase 1 study testing JY09 in people with Diabetes Mellitus, Type 2, run by Beijing Dongfang Biotech Co., Ltd. at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- JY09
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 26 Apr 2018to 22 Jun 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09, a Long-acting Glucagon-like Peptide-1 Mimetic, in Healthy Subjects
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- JY09
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JY09Drug
Also called Placebo
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 0.3-mg | Experimental | Eligible subjects received 0.3 mg placebo or JY09 on day 1 in this cohort Receives: Drug: JY09 |
| Cohort 0.7-mg | Experimental | Eligible subjects received 0.3 mg placebo or JY09 on days 1, and 0.7 mg placebo or JY09 on days 22 Receives: Drug: JY09 |
| Cohort 1.5-mg | Experimental | Eligible subjects received 0.7 mg placebo or JY09 on days 1, and 1.5 mg placebo or JY09 on days 22 Receives: Drug: JY09 |
| Cohort 3.0-mg | Experimental | Eligible subjects received 0.7 mg placebo or JY09 on days 1, and 3.0 mg placebo or JY09 on days 22 Receives: Drug: JY09 |
| Cohort 6.0-mg | Experimental | 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 Receives: Drug: JY09 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events and serious adverse events related to JY09
Measured: Up to day 21
Secondary outcomes (5)
Pharmacodynamics parameters: Cmax
Average Cmax of each dose level
Measured: Up To day 42
Pharmacodynamics parameters: AUC
Average AUC follewing single dose of each doase level
Measured: Up to day 42
Pharmacodynamics parameters: Half-life
Average Half-life of each dose level
Measured: Up to day 42
Pharmacokinetics parameters
OGTT test was conducter predose and 5 days after the target dose in each cohorts
Measured: Day 5
Immunogenicity
Anti-JY09 antibody incidence at each dose level
Measured: Up To day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start26 Apr 2018
- Primary completion27 Dec 2018
- Study completion22 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Dongfang Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juan Li, M.D., Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354090
- Sponsor's protocol ID
- DFBT-JY09-101a
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2020
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09, a Long-acting Glucagon-like Peptide-1 Mimetic, in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04354090
- Acronym / sponsor ID
- DFBT-JY09-101a
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Beijing Dongfang Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 27 Dec 2018 (actual)
- Study completion
- 22 Jun 2019 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 0.3-mg | Experimental | Drug: JY09Eligible subjects received 0.3 mg placebo or JY09 on day 1 in this cohort |
| Cohort 0.7-mg | Experimental | Drug: JY09Eligible subjects received 0.3 mg placebo or JY09 on days 1, and 0.7 mg placebo or JY09 on days 22 |
| Cohort 1.5-mg | Experimental | Drug: JY09Eligible subjects received 0.7 mg placebo or JY09 on days 1, and 1.5 mg placebo or JY09 on days 22 |
| Cohort 3.0-mg | Experimental | Drug: JY09Eligible subjects received 0.7 mg placebo or JY09 on days 1, and 3.0 mg placebo or JY09 on days 22 |
| Cohort 6.0-mg | Experimental | Drug: JY09Eligible 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JY09Also: PlaceboSubcutaneous injection | Drug | Cohort 0.3-mg, Cohort 0.7-mg, Cohort 1.5-mg, Cohort 3.0-mg, Cohort 6.0-mg |
Primary outcome
Incidence of adverse events and serious adverse events related to JY09
Time frame: Up to day 21
5 secondary outcomes
Pharmacodynamics parameters: Cmax
Time frame: Up To day 42
Pharmacodynamics parameters: AUC
Time frame: Up to day 42
Pharmacodynamics parameters: Half-life
Time frame: Up to day 42
Pharmacokinetics parameters
Time frame: Day 5
Immunogenicity
Time frame: Up To day 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Li, M.D. principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JY09 in people with Diabetes Mellitus, Type 2, run by Beijing Dongfang Biotech Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events and serious adverse events related to JY09 (time frame: Up to day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.