Diabete MellitusPhase 1NCT03953092
A Randomized, Double-blind, Placebo-controlled, Sequential Single and Multiple Ascending Doses of YG1699
A Phase 1 study testing YG1699 in people with Diabete Mellitus, run by Youngene Therapeutics Inc., Ltd. at 1 site in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of YG1699 following single and multiple ascending oral dose administration. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabete Mellitus
- What is being tested?
- YG1699
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 13 Nov 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 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 -1, 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
Show all 18Show fewer
- Bilateral salpingectomy (with or without oophorectomy)
- Surgical hysterectomy
- Bilateral oophorectomy (with or without hysterectomy)
- Postmenopausal, defined as the following:
- Last menstrual period greater than 12 months prior to screening
- Postmenopausal status confirmed by serum 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;
- Normal renal function with estimated glomerular filtration rate (eGFR) of 60 ml/min/1.73m2 or greater and as deemed by the Investigator;
- Non-smoker and no more than 2 tobacco-containing including 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;
- Willing and able to adhere to study restrictions and to be confined at the clinical research center.
- 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
- 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;
- Known or suspected malignancy;
- History of pancreatitis or gall stones;
- History of unexplained syncope, symptomatic hypotension or hypoglycemia;
- Family history of long QTc syndrome;
- History of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or intolerance;
Show all 18Show fewer
- Poor venous access;
- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C 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, or illicit drug use within 9 months prior to screening;
- A history of alcohol abuse according to medical history within 9 months prior to screening;
- A positive screen for alcohol, drugs of abuse at screening or Day -1;
- An unwillingness or inability to comply with food and beverage restrictions during study participation;
- Use of over-the-counter (OTC) medication within 7 days, and herbal (including St John's Wort, herbal teas, garlic extracts) 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: A Randomized, Double-blind, Placebo-controlled, Sequential Single and Multiple Ascending Doses (SAD/MAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of YG1699
This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of YG1699 following single and multiple ascending oral dose administration.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of YG1699 following single and multiple ascending oral dose administration.
The study consists of 2 parts: Part 1, SAD dose-escalation; Part 2, MAD dose-escalation.
- Conditions
- Diabete Mellitus
- Being tested
- YG1699, Placebos
- 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 at Multiple Doses
PlacebosDrug
Placebos
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohort 1 | Experimental | 5 mg YG1699 or Placebo Receives: Drug: YG1699; Drug: Placebos |
| SAD Cohort 2 | Experimental | 10 mg YG1699 or placebo Receives: Drug: YG1699; Drug: Placebos |
| SAD Cohort 3 | Experimental | 25 mg YG1699 or placebo Receives: Drug: YG1699; Drug: Placebos |
| SAD Cohort 4 | Experimental | 50 mg YG1699 or placebo Receives: Drug: YG1699; Drug: Placebos |
| SAD Cohort 5 | Experimental | 100 mg YG1699 or placebo Receives: Drug: YG1699; Drug: Placebos |
| MAD Cohort 1 | Experimental | 5 mg YG1699 or placebo Receives: Drug: YG1699; Drug: Placebos |
| MAD Cohort 2 | Experimental | 20 mg YG1699 or placebo Receives: Drug: YG1699; Drug: Placebos |
| MAD Cohort 3 | Experimental | 50 mg YG1699 or placebo Receives: Drug: YG1699; Drug: Placebos |
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: 76 Days
Secondary outcomes (2)
Area Under the Curve [AUC]
area under the plasma drug concentration time curve from time 0 to T (AUC)
Measured: 76 Days
maximum plasma concentration (Cmax)
maximum plasma concentration
Measured: 76 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start1 May 2019
- Primary completion13 Nov 2019
- Study completion13 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete 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 Ascending Dose
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Youngene Therapeutics Inc., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yalin Li, MD, Study director, Youngene Therapeutics Inc., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953092
- Sponsor's protocol ID
- YG1699 -01
- Status last verified
- Jan 2021
- First submitted
- 14 May 2019
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Sequential Single and Multiple Ascending Doses (SAD/MAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of YG1699
- ClinicalTrials.gov ID
- NCT03953092
- Acronym / sponsor ID
- YG1699 -01
- Conditions
- Diabete Mellitus
- Keywords
- Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Youngene Therapeutics Inc., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 May 2019 (actual)
- Primary completion
- 13 Nov 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 16 May 2019 (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, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of YG1699 following single and multiple ascending oral dose administration.
Detailed description
This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of YG1699 following single and multiple ascending oral dose administration.
The study consists of 2 parts: Part 1, SAD dose-escalation; Part 2, MAD dose-escalation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
- Model description
- Single Ascending Dose and Multiple Ascending Dose
| Arm | Type | Receives |
|---|---|---|
| SAD Cohort 1 | Experimental | Drug: YG1699, Drug: Placebos5 mg YG1699 or Placebo |
| SAD Cohort 2 | Experimental | Drug: YG1699, Drug: Placebos10 mg YG1699 or placebo |
| SAD Cohort 3 | Experimental | Drug: YG1699, Drug: Placebos25 mg YG1699 or placebo |
| SAD Cohort 4 | Experimental | Drug: YG1699, Drug: Placebos50 mg YG1699 or placebo |
| SAD Cohort 5 | Experimental | Drug: YG1699, Drug: Placebos100 mg YG1699 or placebo |
| MAD Cohort 1 | Experimental | Drug: YG1699, Drug: Placebos5 mg YG1699 or placebo |
| MAD Cohort 2 | Experimental | Drug: YG1699, Drug: Placebos20 mg YG1699 or placebo |
| MAD Cohort 3 | Experimental | Drug: YG1699, Drug: Placebos50 mg YG1699 or placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 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 -1, and meet one of the following criteria:
- Considered healthy by the Investigator, based on subject's reported medical history, full physical examination, clinical laboratory tests, 12-lead ECG, and vital signs;
- Normal renal function with estimated glomerular filtration rate (eGFR) of 60 ml/min/1.73m2 or greater and as deemed by the Investigator;
Key exclusion criteria (18 listed)
- 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;
- Known or suspected malignancy;
- History of pancreatitis or gall stones;
- History of unexplained syncope, symptomatic hypotension or hypoglycemia;
- Family history of long QTc syndrome;
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 at Multiple Doses | Drug | MAD Cohort 1, MAD Cohort 2, MAD Cohort 3, SAD Cohort 1, SAD Cohort 2, SAD Cohort 3, SAD Cohort 4, SAD Cohort 5 |
| PlacebosPlacebos | Drug | MAD Cohort 1, MAD Cohort 2, MAD Cohort 3, SAD Cohort 1, SAD Cohort 2, SAD Cohort 3, SAD Cohort 4, SAD Cohort 5 |
Primary outcome
Adverse events will be evaluated
Time frame: 76 Days
Safety and Tolerability of YG1699
2 secondary outcomes
Area Under the Curve [AUC]
Time frame: 76 Days
maximum plasma concentration (Cmax)
Time frame: 76 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 11 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Diabete Mellitus
Recruiting
Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and Identification of Its Associated Factors.
Diabetes Mellitus, Psychological Distress
Not yet recruiting
The Effect of Individualized Nursing Interventions on Glycemic Variability and Self-Management in Type 2 Diabetes
Type 2 Diabetes Mellitus (T2DM)
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
Recruiting
Effects of Medisinstart for Type 2 Diabetes
Type 2 Diabetes
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.
Yalin Li, MD 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 Diabete Mellitus, run by Youngene Therapeutics Inc., Ltd. at 1 site in United States.
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 18 inclusion and 18 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 11 Jan 2021. 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 United States. 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: 76 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 11 Jan 2021.