Diabetes MellitusPhase 1NCT05089617
To Evaluate the Safety, Tolerability, and Pharmacokinetics of YG1699（Antidiabetic） in Healthy Chinese Sbjects
A Phase 1 study testing YG1699 in people with Diabetes Mellitus, run by Youngene Therapeutics Inc., Ltd. at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multi-dose, sequential, bridging study in healthy volunteer using YG1699 . Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- YG1699
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2022to 12 Aug 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are capable of giving informed consent and complying with study procedures;
- Are between the ages of 18 and 55 years, inclusive;
- Female subjects have a negative urine pregnancy test result at screening and Day 0, and meet one of the following criteria:
- Using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives) [e.g., hormonal contraceptives (oral, patch, injectable or vaginal ring), implantable device (implantable rod or intrauterine device), or a double barrier (e.g., diaphragm, cervical cap, oral, patch or vaginal hormonal contraceptive, condom, spermicide, or sponge)]
- Surgically sterile for at least 3 months prior to screening by one of the following means:
- Bilateral tubal ligation Bilateral salpingectomy (with or without oophorectomy) Surgical hysterectomy Bilateral oophorectomy (with or without hysterectomy)
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- Postmenopausal, defined as the following:
- Last menstrual period greater than 12 months prior to screening Postmenopausal status confirmed by serum Follicle-Stimulating Hormone（FSH） and estradiol levels at screening;
- Considered healthy by the Investigator, based on subject's reported medical history, full physical examination, clinical laboratory tests, 12-lead ECG, and vital signs;
- Non-smoker and less than 5 cigarettes/day or nicotine replacement products in last 6 months;
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 inclusive and body weight not less than 50 kg;
- Male subjects with female partners of child bearing potential must agree to use condoms for the duration of the study and until 12 weeks after dosing with the study drug and must refrain from donating sperm for this same period.
Who cannot join
- Subjects of non-Chinese nationality living or working in China, or persons of non-East Asian descent who are Chinese nationals;
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator;
- History of food or drug allergy;
- Known or suspected malignancy;
- History of unexplained syncope, symptomatic hypotension or hypoglycemia;
- History or family history of long corrective QT interval（QTc） syndrome;
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- History of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or intolerance;
- Poor venous access;
- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C antibody or treponema pallidum antibody ;
- Donated or lost >500ml of blood in the previous 3 months;
- Taken an investigational drug or participated in a clinical trial within 3 months (or 5 half-lives), whichever is longer;
- Taken any prescription medications within 14 days or 5 half-lives (whichever is longer) of the first dose of study drug;
- Hospital admission or major surgery within 6 months prior to screening;
- A history of prescription drug abuse within 9 months prior to screening;
- A history of alcohol abuse according to medical history within 9 months prior to screening;
- Female subjects with positive pregnancy test, pregnant or breastfeeding;
- A positive screen for alcohol, drugs of abuse at screening;
- An unwillingness or inability to comply with food and beverage restrictions during study participation;
- Use of over-the-counter (OTC) medication and herbal within 7 days prior to dosing (Note: Use of acetaminophen at < 2 g/day is permitted until 24 hours prior to dosing);
- Any condition or finding that in the Investigators opinion would put the subject or study conduct at risk if the subject were to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Administration of YG1699 in Healthy Chinese Subjects: a Randomized, Double-blind, Placebo-controlled, Single Ascending Dose (SAD) and Multi-dose, Sequential, Bridging Study
This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multi-dose, sequential, bridging study in healthy volunteer using YG1699 .
Read the detailed description
This is a randomized, double-blind, placebo-controlled, dose-ascending study to evaluate the safety, tolerability, and pharmacokinetics (PK) of YG1699 following single ascending and multiple oral dose administration.
The study consists of 2 parts: Part 1, SAD dose- ascending; Part 2, multi-dose ascending.
- Conditions
- Diabetes Mellitus
- Being tested
- YG1699
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YG1699Drug
YG1699 is a novel investigational dual inhibitor of sodium-dependent glucose cotransporters, SGLT1 and SGLT2, indicated as an adjunct to diet and exercise to improve glycemic control and weight loss in adults with T2DM. A subsequent indication will be developed for YG1699 to improve glycemic control in adults with T1DM.
Drug: Placebo
Placebo is the same appearance as YG1699.
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohort 1 | Experimental | 5 mg YG1699 or Placebo Receives: Drug: YG1699 |
| SAD Cohort 2 | Experimental | 25 mg YG1699 or Placebo Receives: Drug: YG1699 |
| Multiple Doses Cohort 1 | Experimental | 20 mg YG1699 or Placebo Receives: Drug: YG1699 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events will be evaluated
Safety and Tolerability of YG1699
Measured: 81 Days
Secondary outcomes (2)
Area Under the Curve [AUC]
area under the plasma drug concentration time curve from time 0 to T (AUC)
Measured: 81 Days
maximum plasma concentration (Cmax)
maximum plasma concentration
Measured: 81 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start9 Jan 2022
- Primary completion12 Aug 2022
- Study completion12 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Single Ascending Dose and Multiple Dose
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Youngene Therapeutics Inc., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiaojuan He, Master, Study director, Youngene Therapeutics Inc., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089617
- Sponsor's protocol ID
- YG1699-102
- Status last verified
- Jan 2022
- First submitted
- 26 Sep 2021
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Administration of YG1699 in Healthy Chinese Subjects: a Randomized, Double-blind, Placebo-controlled, Single Ascending Dose (SAD) and Multi-dose, Sequential, Bridging Study
- ClinicalTrials.gov ID
- NCT05089617
- Acronym / sponsor ID
- YG1699-102
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Youngene Therapeutics Inc., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jan 2022 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 12 Aug 2022 (actual)
- First posted
- 22 Oct 2021 (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.
This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multi-dose, sequential, bridging study in healthy volunteer using YG1699 .
Detailed description
This is a randomized, double-blind, placebo-controlled, dose-ascending study to evaluate the safety, tolerability, and pharmacokinetics (PK) of YG1699 following single ascending and multiple oral dose administration.
The study consists of 2 parts: Part 1, SAD dose- ascending; Part 2, multi-dose ascending.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Single Ascending Dose and Multiple Dose
| Arm | Type | Receives |
|---|---|---|
| SAD Cohort 1 | Experimental | Drug: YG16995 mg YG1699 or Placebo |
| SAD Cohort 2 | Experimental | Drug: YG169925 mg YG1699 or Placebo |
| Multiple Doses Cohort 1 | Experimental | Drug: YG169920 mg YG1699 or Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Are capable of giving informed consent and complying with study procedures;
- Are between the ages of 18 and 55 years, inclusive;
- Female subjects have a negative urine pregnancy test result at screening and Day 0, and meet one of the following criteria:
- Bilateral tubal ligation Bilateral salpingectomy (with or without oophorectomy) Surgical hysterectomy Bilateral oophorectomy (with or without hysterectomy)
- Last menstrual period greater than 12 months prior to screening Postmenopausal status confirmed by serum Follicle-Stimulating Hormone（FSH） and estradiol levels at screening;
Key exclusion criteria (20 listed)
- Subjects of non-Chinese nationality living or working in China, or persons of non-East Asian descent who are Chinese nationals;
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator;
- History of food or drug allergy;
- Known or suspected malignancy;
- History of unexplained syncope, symptomatic hypotension or hypoglycemia;
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 |
|---|---|---|
| YG1699YG1699 is a novel investigational dual inhibitor of sodium-dependent glucose cotransporters, SGLT1 and SGLT2, indicated as an adjunct to diet and exercise to improve glycemic control and weight loss in adults with T2DM. A subsequent indication will be developed for YG1699 to improve glycemic control in adults with T1DM. Drug: Placebo Placebo is the same appearance as YG1699. | Drug | Multiple Doses Cohort 1, SAD Cohort 1, SAD Cohort 2 |
Primary outcome
Adverse events will be evaluated
Time frame: 81 Days
Safety and Tolerability of YG1699
2 secondary outcomes
Area Under the Curve [AUC]
Time frame: 81 Days
maximum plasma concentration (Cmax)
Time frame: 81 Days
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 31 Jan 2023.
- 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.
Jiaojuan He, Master study director
Youngene Therapeutics Inc., Ltd.
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 YG1699 in people with Diabetes Mellitus, run by Youngene Therapeutics Inc., 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 12 inclusion and 20 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 31 Jan 2023. 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?
Adverse events will be evaluated (time frame: 81 Days). 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 31 Jan 2023.