Stroke, AcutePhase 1NCT03495206
Safety, Tolerability and Pharmacokinetics of Y-2(Edaravone And Borneol) Sublingual Tablet
A Phase 1 study testing Y-2(Edaravone And Borneol) Sublingual Tablet in people with Stroke, Acute and Intracranial Hemorrhages, run by Yantai YenePharma Co., Ltd. at 1 site in United States.
Trial summary
The primary objective is to evaluate the safety and tolerability of single ascending dose of Y-2 sublingual tablets in healthy male and female adult subjects. The secondary objective is to characterize the single-dose pharmacokinetics of Y-2 sublingual tablets in healthy male and female adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Acute, Intracranial Hemorrhages
- What is being tested?
- Y-2(Edaravone And Borneol) Sublingual Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2018to Feb 2021
- 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
- Healthy adult male and female subjects, 18-55 years of age, Body weight ≥ 50 kg and body mass index (BMI) within the range of 18 - 30 kg/m2;
- Women of childbearing potential with a negative urine pregnancy test at screening and check-in, who are not breastfeeding, do not plan to become pregnant during the study, and agree to use an approved alternative method of family planning during the study;
- Male subjects must agree to use barrier contraception (condom with spermicide) in addition to having their female partner (if of child-bearing potential) use another acceptable form of contraception (IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, or subdermal hormonal implant) from first dose until 30 days following the last administration of study drug;
- Female subjects, if of child-bearing potential, must agree to use an acceptable form of contraception (IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, or subdermal hormonal implant) in addition to having their male partner use barrier contraception (condom with spermicide) from first dose until 30 days following the last administration of study drug. Female subjects who are NOT of child-bearing potential include those who have a history of tubal ligation, hysterectomy, or bilateral salpingo oopherectomy, or who have had no menstrual period for >12 months, confirmed by a screening follicle stimulating hormone (FSH) level in the post-menopausal range;
- Hemoglobin level within normal limits (WNL) of the reference laboratory value (one repeat is allowed for a hemoglobin level that falls within 0.3 g/dL of the upper or lower limit of the reference range);
- Subjects who are able to understand and give their signed informed consent before any trial related procedures are performed.
Who cannot join
- Subjects have a history of, cancer (not including basal cell skin cancer greater than 5 years prior), diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, hematological, dermatological, neurological, psychiatric or other major disorder;
- Presence or history of hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of medicines;
- Urine protein > trace on a standard dip stick test (1 repeat allowed); Microscopic hematuria defined as >5 red blood cells (RBC) per high powered field (HPF) in a male or a non-menstruating female; may allow for 1 repeat test after 7 days of screening, including (but not limited to) females who are menstruating at the time of screening;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times the ULN;
- Systolic blood pressure (SBP) outside the range of 90 to 140 mmHg, diastolic blood pressure (DBP) outside the range of 40 to 90 mmHg, and/or pulse rate outside the range of 40 to 100 bpm at screening or check-in. One repeat blood pressure measurement may be performed if SBP is between 141 and 150 mmHg or DBP is between 91 and 95;
- Clinically significant abnormality on ECG in the judgment of the Investigator;
Show all 22Show fewer
- Reticulocyte value (percent reticulocytes) of more than 1% above the upper limit of normal (ULN) for the reference laboratory;
- Oxygen saturation by pulse oximetry <95%;
- History of clinically significant drug and/or food allergies as determined by the Principal Investigator (PI);
- History of clinically significant cardiac arrhythmia;
- Subject is not willing to abstain from alcohol for 48 hours prior to the start of the first dose until completion of the post-study follow-up assessments; or the average weekly alcohol intake of greater than 21 units or an average daily intake of greater than 3 units (One unit is equivalent to a half-pint of beer or 1 measure of spirits or 1 glass of wine.); recent history (within 2 years) or currently diagnosed alcohol or drug abuse, in the judgement of the Investigator;
- Tobacco or nicotine replacement product use within the 6 months prior to first dose through the follow-up visit, or a positive urine screen for cotinine;
- Hypersensitivity or idiosyncratic reaction to compounds related to the study drug (e.g. sulfite);
- Use of substances known to be strong inhibitors or inducers of cytochrome P450 enzymes within 14 days prior to the first dose;
- Use of prescription or non-prescription drugs including vitamins, herbal and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication;
- Consumption of food or beverage containing grapefruit or cranberry within 7 days prior to the first dose of study medication;
- Donation of whole blood in excess of 500 mL within 30 days prior to check in;
- Plasma donation within 7 days prior to check-in;
- Subject participated in an investigational clinical study within 30 days (of last dose of previous study drug) prior to the first dosing, or within days calculated as 10 times the half-life of the compound that the subject was treated with, whichever is longer or participated in the early cohorts of the current study. Factors other than the half-life of the compound, such as accumulation of tissue, muscle or organ, should also be considered for the enrollment;
- Positive urine screen for drugs of abuse at screening or check-in; or
- Any condition that, in the opinion of the Principal Investigator, would complicate or compromise the study, or the well-being of the subject.
- Any other serious underlying medical conditions (e.g. uncontrolled diabetes mellitus, uncontrolled hypertension, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, cardiac conditions), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect subject compliance or place the subject at high risk from treatment-related complications.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
OSF Healthcare System d/b/a Saint Francis Medical
Peoria, Illinois, 61637
David Z Wang, M.D
David Z Wang, M.D
About this study
Official title: Sublingual Y-2(Edaravone And Borneol) Tablet For Acute Ischemic And Hemorrhagic Patients-the SALVAGE Trial
The primary objective is to evaluate the safety and tolerability of single ascending dose of Y-2 sublingual tablets in healthy male and female adult subjects. The secondary objective is to characterize the single-dose pharmacokinetics of Y-2 sublingual tablets in healthy male and female adult subjects.
Read the detailed description
This study will be a single-center, single ascending dose study in healthy male and female subjects. A total of 24 subjects, 4 cohorts of 6 subjects each, will be enrolled in this study. All of the 6 subjects in each cohort will receive a single dose of Y-2 sublingual tablet on a single occasion. Prior to taking the drug and after taking the drug at 5 min to 24 h, venous blood from all subjects will be collected at different time points for PK analysis. After dosing, safety and tolerability data for each cohort will be evaluated.
- Conditions
- Stroke, Acute, Intracranial Hemorrhages
- Being tested
- Y-2(Edaravone And Borneol) Sublingual Tablet
- Medical subject headings
- Stroke, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y-2(Edaravone And Borneol) Sublingual TabletDrug
Y-2 sublingual tablet at single ascending doses of one tablet , two tablets, three tablets, four tablets
| Study group | Role | What they receive |
|---|---|---|
| Y-2(Edaravone And Borneol) sublingual tablet | Experimental | Not described Receives: Drug: Y-2(Edaravone And Borneol) Sublingual Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who experience treatment-related adverse events (AEs) and serious adverse events (SAEs)
Any untoward medical events during this study were categorized as severe, moderate, or mild, and related or not related to study treatment
Measured: 0 hours to 36 hours
Secondary outcomes (3)
Maximum Plasma Concentration [Cmax]
To evaluate Maximum Plasma Concentration [Cmax] of Y-2 in patients tested
Measured: 0 hours to 24 hours
Time of Observed Cmax[tmax]
To evaluate Time of Observed Cmax[tmax] of Y-2 in patients tested
Measured: 0 hours to 24 hours
Area Under the concentration-time Curve from time zero to the last detectable concentration[AUC0-t]
To evaluate Area Under the concentration-time Curve from time zero to the last detectable concentration[AUC0-t] of Y-2 in patients tested
Measured: 0 hours to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start25 Oct 2018
- Primary completionDec 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies 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
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yantai YenePharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495206
- Sponsor's protocol ID
- Y-2-001
- Status last verified
- Feb 2020
- First submitted
- 21 Mar 2018
- Last updated
- 17 Feb 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublingual Y-2(Edaravone And Borneol) Tablet For Acute Ischemic And Hemorrhagic Patients-the SALVAGE Trial
- ClinicalTrials.gov ID
- NCT03495206
- Acronym / sponsor ID
- Y-2-001
- Conditions
- Stroke, Acute, Intracranial Hemorrhages
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Yantai YenePharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 11 Apr 2018 (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.
The primary objective is to evaluate the safety and tolerability of single ascending dose of Y-2 sublingual tablets in healthy male and female adult subjects. The secondary objective is to characterize the single-dose pharmacokinetics of Y-2 sublingual tablets in healthy male and female adult subjects.
Detailed description
This study will be a single-center, single ascending dose study in healthy male and female subjects. A total of 24 subjects, 4 cohorts of 6 subjects each, will be enrolled in this study. All of the 6 subjects in each cohort will receive a single dose of Y-2 sublingual tablet on a single occasion. Prior to taking the drug and after taking the drug at 5 min to 24 h, venous blood from all subjects will be collected at different time points for PK analysis. After dosing, safety and tolerability data for each cohort will be evaluated.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Y-2(Edaravone And Borneol) sublingual tablet | Experimental | Drug: Y-2(Edaravone And Borneol) Sublingual Tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adult male and female subjects, 18-55 years of age, Body weight ≥ 50 kg and body mass index (BMI) within the range of 18 - 30 kg/m2;
- Women of childbearing potential with a negative urine pregnancy test at screening and check-in, who are not breastfeeding, do not plan to become pregnant during the study, and agree to use an approved alternative method of family planning during the study;
- Male subjects must agree to use barrier contraception (condom with spermicide) in addition to having their female partner (if of child-bearing potential) use another acceptable form of contraception (IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, or subdermal hormonal implant) from first dose until 30 days following the last administration of study drug;
- Female subjects, if of child-bearing potential, must agree to use an acceptable form of contraception (IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, or subdermal hormonal implant) in addition to having their male partner use barrier contraception (condom with spermicide) from first dose until 30 days following the last administration of study drug. Female subjects who are NOT of child-bearing potential include those who have a history of tubal ligation, hysterectomy, or bilateral salpingo oopherectomy, or who have had no menstrual period for >12 months, confirmed by a screening follicle stimulating hormone (FSH) level in the post-menopausal range;
- Hemoglobin level within normal limits (WNL) of the reference laboratory value (one repeat is allowed for a hemoglobin level that falls within 0.3 g/dL of the upper or lower limit of the reference range);
Key exclusion criteria (22 listed)
- Subjects have a history of, cancer (not including basal cell skin cancer greater than 5 years prior), diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, hematological, dermatological, neurological, psychiatric or other major disorder;
- Presence or history of hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of medicines;
- Systolic blood pressure (SBP) outside the range of 90 to 140 mmHg, diastolic blood pressure (DBP) outside the range of 40 to 90 mmHg, and/or pulse rate outside the range of 40 to 100 bpm at screening or check-in. One repeat blood pressure measurement may be performed if SBP is between 141 and 150 mmHg or DBP is between 91 and 95;
- Clinically significant abnormality on ECG in the judgment of the Investigator;
- Reticulocyte value (percent reticulocytes) of more than 1% above the upper limit of normal (ULN) for the reference laboratory;
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 |
|---|---|---|
| Y-2(Edaravone And Borneol) Sublingual TabletY-2 sublingual tablet at single ascending doses of one tablet , two tablets, three tablets, four tablets | Drug | Y-2(Edaravone And Borneol) sublingual tablet |
Primary outcome
Number of participants who experience treatment-related adverse events (AEs) and serious adverse events (SAEs)
Time frame: 0 hours to 36 hours
Any untoward medical events during this study were categorized as severe, moderate, or mild, and related or not related to study treatment
3 secondary outcomes
Maximum Plasma Concentration [Cmax]
Time frame: 0 hours to 24 hours
Time of Observed Cmax[tmax]
Time frame: 0 hours to 24 hours
Area Under the concentration-time Curve from time zero to the last detectable concentration[AUC0-t]
Time frame: 0 hours to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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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.
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 Y-2(Edaravone And Borneol) Sublingual Tablet in people with Stroke, Acute and Intracranial Hemorrhages, run by Yantai YenePharma Co., 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 6 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 17 Feb 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Z. Wang, M.D. ((309) 624-9500, david.wang@chinastroke.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who experience treatment-related adverse events (AEs) and serious adverse events (SAEs) (time frame: 0 hours to 36 hours). 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 17 Feb 2020.