A Phase 1 interventional study of Y-2(Edaravone And Borneol) Sublingual Tablet in Stroke, Acute and Intracranial Hemorrhages, sponsored by Yantai YenePharma Co., Ltd.. Status unknown at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-17.
Sponsored by Yantai YenePharma Co., Ltd. · Phase 1, Interventional, and Treatment
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Among 1,994 studies in Stroke with a site in United States — 395 open to participants now, 492 under way, 17 of them phase 3. Stroke · United States.
Among the 1,994 studies in Stroke with a site in United States, this one is the 1,029th largest by planned enrollment of the 1,620 interventional ones that give a count, is one of 105 that started in 2018, is one of 126 in phase 1, and was the 1,045th registered.
8,268 studies on the registry are indexed under Stroke; 2,062 are open to participants now.
Browse Stroke studies →395 of the 1,994 studies in Stroke with a site in United States are open now. Recruiting first, the newest first:
University of Utah · Sites in United States
Ages 40–85
Carle Foundation Hospital · Sites in United States
Ages 18+
Weill Medical College of Cornell University · Sites in United States
Ages 18–79
Neuralink Corp · Sites in United States
Ages 18+
Casa Colina Hospital and Centers for Healthcare · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 1,418 Stroke studies recruiting now, 696 (49%) set no upper age limit and 282 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,994 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 173 · Phase 2 235 · Phase 3 126 · Phase 4 43
First in 1980; this study’s year is marked. 105 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 24 is below the median of 49 across 6,036 interventional studies indexed under Stroke.
Median enrollment 40 across the 1,620 interventional studies, 153 across the 363 observational. Of the 1,328 that completed or were terminated, 563 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
295 of 1,994 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Yantai YenePharma Co., Ltd. as lead sponsor.
Yantai YenePharma Co., Ltd. has 1 study filed under Stroke — fewer than ten, so there is no comparison to draw.
164 of the studies in Stroke with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05065216Phase 3DiaMedica Therapeutics IncTreatment of Acute Ischemic Stroke (ReMEDy2 Trial) | 2026-12 |
| NCT03223220Phase 3Lower Merion Neurology Research FoundationQuelling of Excitotoxicity in Acute Stroke With Ketamine | 2026-12-31 |
| NCT05047172Phase 3University of FloridaComparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis | 2027-01-31 |
| NCT05691244Phase 3Pharmazz, Inc.Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke | 2027-09 |
| NCT05997914University of Massachusetts, WorcesterStorytelling for Reducing Gap in Anticoagulation Use in African Americans With Atrial Fibrillation | 2026-11 |
Add all 164 to your calendar (.ics) → With an account.
Among the 1,994 studies in Stroke with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Presence or history of hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of medicines;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Y-2(Edaravone And Borneol) Sublingual Tablet
Y-2 sublingual tablet at single ascending doses of one tablet , two tablets, three tablets, four tablets
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
Time frame: 0 hours to 36 hours
Maximum Plasma Concentration [Cmax]
To evaluate Maximum Plasma Concentration \[Cmax\] of Y-2 in patients tested
Time frame: 0 hours to 24 hours
Time of Observed Cmax[tmax]
To evaluate Time of Observed Cmax\[tmax\] of Y-2 in patients tested
Time frame: 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
Time frame: 0 hours to 24 hours
Started Oct 2018 (actual). Primary completion is estimated for Dec 2020, 26 months after the start.
Of 26 industry-sponsored phase 1 interventional studies under Stroke, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 14. This study's planned 26 months is above that.
Counting every sponsor, half of 97 studies reached it within 20 months; a quarter within 7 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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