SafetyPhase 1NCT06770491
A Phase 1 Study of Y-3 in US Healthy Volunteers.
A Phase 1 study testing Y-3 for injection in people with Safety and Tolerability, run by Neurodawn Pharmaceutical Co., Ltd. at 1 site in United States.
Trial summary
The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetic profiles of Y-3 in healthy adult volunteers in the United States. The main questions it aims to answer are: What the pharmacokinetic profiles of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers?… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety, Tolerability, Pharmacokinetic Study in Healthy Volunteers
- What is being tested?
- Y-3 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2025to 20 Sep 2025
- 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
- Medically documented as healthy at the time of screening as determined by their medical history, medical assessment, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory tests, etc.
- Within 18-45 years at the time of informed consent, inclusive.
- Body weight ≥ 50 kg for male and ≥ 45 kg for female, body mass index (BMI) within the range of 19 - 28 kg/m2, inclusive.
- Fully understand and provide a signed informed consent before performing any study-related procedures.
- Comply with the study and follow-up procedures.
Who cannot join
- Known allergy to Y-3 or any of its excipients.
- Have disease history or current disease that may affect the safety evaluation of the subject or the internal process of the study drug, that the investigator judged to be of clinical significance, including the cardiovascular system, endocrine system, central nervous system, digestive system, respiratory system, hematological system, immunology, psychiatry, metabolic abnormalities, etc.
- Clinically significant abnormal 12-lead electrocardiograms (ECG) and vital signs judged by the investigator.
- Clinically significant abnormal laboratory tests (hematology, serum chemistry, coagulation, urinalysis, etc.) and other screening tests judged by the investigator.
- Test positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, syphilis antibody or human immunodeficiency virus (HIV) antibody.
- Alcoholics or regular drinkers within 6 months prior to screening, that is, those who drink more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of alcohol with 40% alcohol content or 150 mL of wine), or whose alcohol breath test results are greater than 0.0 mg/100 mL, or who cannot abstain from alcohol during the study.
Show all 17Show fewer
- Smokers, that is, those who smoke more than 3 cigarettes per day within 3 months prior to screening, or those who cannot comply with the prohibition of smoking during the study.
- Current or former drug users, or positive urine screen for drugs of abuse at screening.
- Have special requirements for diet and cannot follow the unified diet.
- Drink too much tea, coffee and/or caffeine-containing beverages (more than 8 cups, 1 cup = 250 mL) every day within 3 months prior to screening, or who have consumed any diet (food or beverage) rich in grapefruit, pitaya and mango within 14 days prior to screening.
- Have taken any prescription drug or over-the-counter drug, traditional Chinese medicine or herbal medicine, health products within 14 days prior to screening, or 5 half-lives, whichever is longer, before the first dose of study drug, or have received vaccine inoculation within 14 days prior to screening; or plan to inoculate vaccine during the study.
- Participated in any other clinical trials within 3 months prior to screening.
- Donation or loss of blood equal to or in excess of 200 mL within 3 months prior to screening.
- Female subjects who have unprotected intercourse within 14 days prior to screening, or pregnant or lactating women.
- Male subjects (or their partners) or female subjects have baby plans during the whole trial period and within 3 months after the end of the trial, or subjects are unwilling to take one or more non-drug contraceptive measures (such as complete abstinence, condoms, ligation, etc.) during the study.
- Subjects voluntarily withdraw from the study due to personal reason, or subjects who the investigator believes are not suitable for enrollment for other reasons.
- Suicidal ideation, history of suicidal behavior, or history of psychiatric comorbidities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profiles of Y-3 in Healthy Adult Volunteers in the United States
The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetic profiles of Y-3 in healthy adult volunteers in the United States. The main questions it aims to answer are:
- What the pharmacokinetic profiles of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers?
- If drug Y-3 (40mg and 60 mg) is safe and tolerate in the US healthy adult volunteers.
Read more
Researchers will compare drug Y-3 (40 mg and 60 mg) to a placebo (a look-alike substance that contains no drug) to see what the pharmacokinetic profiles of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers and if drug Y-3 (40mg and 60 mg) is safe and tolerate in the US healthy adult volunteers.
Participants will:
- Take drug Y-3 (40 mg) or Y-3 (60 mg) or a placebo only once.
- Answer questions regarding your medical history.
- Comply with the study procedures and requests.
- Complete all tests and collections of PK Sampling.
- Must not have any special dietary requirements and be able to consume the food (low-fat) provided by Tranquil Clinical Research during your 4-night stay.
- Must avoid excessive ( > 8 cups per day) caffeine consumption (i.e. coffee or tea) during your time in the study.
- Must not consume any food or beverage rich in grapefruit, papaya, or mango during your time in the study.
- Must not take any other medications, including traditional Chinese medicines and herbal medicines, during your time in the study.
- Must avoid sexual activity or use non-drug contraceptive measures (i.e. condoms) during your time in the study.
- Female participants must not become pregnant while in the study.
- Must not receive any vaccinations during your time in the study.
- Must not donate blood for purposes outside of study procedures during your time in the study.
- Must not drink alcohol during your time in the study.
- Must not smoke during your time in the study.
- Inform your Study Doctor if you no longer wish to participate in the study.
- Being tested
- Y-3 for injection, Placebo
- Keywords
- safety, tolerability, Pharmacokinetic study in healthy volunteers, Y-3, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y-3 for injectionDrug
The investigational drug (Y-3) consists of two parts: Y-3 for injection (lyophilized powder) and Solvent for Y-3 for injection (concentrated solution).
Name: Y-3 for injection Strength: 20 mg Dosage Form: Lyophilized powder for injection Storage Condition: 2-8°C Supplier: Neurodawn Pharmaceutical Co., Ltd. Name: Reconstitution diluent for Y-3 for injection Strength: 3ml (containing 0.6 g propylene glycol) Dosage Form: Concentrated solution for injection Storage Condition: 2-8°C Supplier: Neurodawn Pharmaceutical Co., Ltd.
PlaceboDrug
The placebo consists of two parts: placebo (lyophilized powder) and Solvent for Y-3 for injection(concentrated solution).
Name: Placebo Strength: 0 mg Dosage Form: Lyophilized powder for injection Storage Condition: 2-8°C Supplier: Neurodawn Pharmaceutical Co., Ltd. Name: Solvent for Y-3 for injection Strength: 3 mL (containing 0.6 g propylene glycol) Dosage Form: Concentrated solution for injection Storage Condition: 2-8°C Supplier: Neurodawn Pharmaceutical Co., Ltd.
| Study group | Role | What they receive |
|---|---|---|
| Y-3 for injection (Y-3) | Experimental | The investigational drug (Y-3) consists of two parts: Y-3 for injection (lyophilized powder) （20 mg）and Solvent for Y-3 for injection (concentrated solution)（3ml (containing 0.6 g propylene glycol)）.
Subjects will receive Y-3 or placebo on the morning of the dosing day. Drinking water is prohibited from 1 hour before administration until the end of dosing, and subjects may have meals 4 hours after administration.
Using a sterile syringe, withdraw dedicated solution into the lyophilized powder vial of Y-3 or placebo. Shake the vial manually until the powder is dissolved. Once completely dissolved, use a sterile syringe to transfer the solution into the infusion bottle (normal saline) and gently mix by swirling. The intravenous infusion volume is 250 ml, and infusion time is 60 min ± 10 min. The storage time of the reconstituted drug product or placebo should not exceed 4 hours at room temperature or 24 hours at refrigerated temperature prior to initiation of administration. Receives: Drug: Y-3 for injection |
| placebo | Placebo comparator | The placebo consists of two parts: placebo (lyophilized powder) and Solvent for Y-3 for injection(concentrated solution).
Subjects will receive Y-3 or placebo on the morning of the dosing day. Drinking water is prohibited from 1 hour before administration until the end of dosing, and subjects may have meals 4 hours after administration.
Using a sterile syringe, withdraw dedicated solution into the lyophilized powder vial of Y-3 or placebo. Shake the vial manually until the powder is dissolved. Once completely dissolved, use a sterile syringe to transfer the solution into the infusion bottle (normal saline) and gently mix by swirling. The intravenous infusion volume is 250 ml, and infusion time is 60 min ± 10 min. The storage time of the reconstituted drug product or placebo should not exceed 4 hours at room temperature or 24 hours at refrigerated temperature prior to initiation of administration. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Cmax of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin
Maximum observed plasma concentration. It was obtained directly from the measured plasma concentration-time data.
Measured: treatment period (Day1-Day4)
Evaluate the AUC 0-t of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration.
Calculated according to linearity trapezoidal rule:
AUC (i, i+1) = (Ti+1-Ti) (Ci+Ci+1) /2, and AUC0-t is the sum of all AUC (i, i + 1).
Measured: treatment period (Day1-Day4)
Evaluate the AUC 0-∞ of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Area under the concentration-time curve from time 0 to infinity (extrapolated). AUC 0-∞ =AUC 0-t + Ct/λz (Ct is the last measured plasma concentration).
Measured: treatment period (Day1-Day4)
Evaluate the Tmax of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Time to reach maximum observed plasma concentration. It was obtained directly from the measured plasma concentration-time data.
Measured: treatment period (Day1-Day4)
Evaluate the t1/2 of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Terminal elimination half-life. t1/2 = ln2/λ。
Measured: treatment period (Day1-Day4)
Evaluate the λz of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Terminal-phase elimination rate constant, slope of curves terminal segment at semi-log concentration-time curve calculated by linear regression.
Measured: treatment period (Day1-Day4)
Evaluate the AUC_%Extrap of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
The percentage of the AUC0-inf that has been extrapolated. AUC_%Extrap = [(AUC0-∞-AUC0-t)/AUC0-∞] × 100%
Measured: treatment period (Day1-Day4)
Evaluate the Vz of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Volume of distribution. Vz = Div/AUC0-∞/λz
Measured: treatment period (Day1-Day4)
Evaluate the CL of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Total body clearance. CLz = Div /AUC0-∞
Measured: treatment period (Day1-Day4)
Evaluate the MRT 0-t of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Mean residence time within the time from time zero to the lowest testing plasma concentration. MRT0-t = AUMC0-t/AUC0-t.
Measured: treatment period (Day1-Day4)
Evaluate the MRT 0-∞ of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Mean residence time extrapolated from zero to infinity. MRT 0-∞ = AUMC 0-∞/AUC 0-∞.
Measured: treatment period (Day1-Day4)
Secondary outcomes (10)
Evaluate the safety of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by Incidence of subject getting abnormal results of physical examinations after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Physical examinations will be conduct by the investigator through observation.
Measured: This study comprises a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period (Day1 - Day4), and a safety follow-up period (Day7).
Evaluate the safety of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by Incidence of subject getting abnormal results of vital signs after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Vital signs(blood pressure, respiration, pulse, body temperature） will be assessed by according equipments.(electronic sphygmomanometer，thermometer).
Measured: This study comprises a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period (Day1 - Day4), and a safety follow-up period (Day7).
Evaluate the safety of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by Incidence of subject getting abnormal results of 12-lead ECG after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. 12-lead ECG will be analyzed by single RR Heart Rate, aggregate PR Interval, aggregate QRS Duration, aggregate RR Interval, aggregate QT Interval, aggregate QTC Interval. Normal range is provided by the site.
Measured: This study comprises a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period (Day1 - Day4), and a safety follow-up period (Day7).
Evaluate the safety of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by Incidence of subject getting abnormal results of laboratory tests after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Laboratory tests are composed of hematology, urinalysis, serum chemistry, coagulation test. Normal range is provided by the site.
Measured: This study comprises a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period (Day1 - Day4), and a safety follow-up period (Day7).
Evaluate the safety of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by the rates of adverse events after treatment.
An AE is defined as any untoward medical event that occurs after receiving a drug or treatment or any deterioration of a disease or symptom that existed before receiving the investigational product or treatment (excluding the disease studied in this trial) in a subject or a clinical investigation subject, whether or not considered related to the investigational product or treatment. Therefore, an AE can be a discomfort sign (including an abnormal laboratory finding), symptom, or transient disease beyond any indication, whether or not related to the investigational product or treatment.
The investigator will name each AE reported during the study by MedDRA PT and evaluate their severity using the criteria of "mild", "moderate" and "severe".
The relevance evaluation is divided into 5 grades: 1-certainly related; 2- probably/likely related; 3-possibly related; 4-unlikely related; 5 not related.
Measured: This study comprises a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period (Day1 - Day4), and a safety follow-up period (Day7).
Evaluate the tolerability of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by Incidence of subject getting abnormal results of physical examinations after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Physical examinations will be conduct by the investigator through obeservation.
Measured: This study comprises a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period (Day1 - Day4), and a safety follow-up period (Day7).
Evaluate the tolerability of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by Incidence of subject getting abnormal results of vital signs after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Vital signs(blood pressure, respiration, pulse, body temperature） will be assessed by according equipment.(electronic sphygmomanometer，thermometer).
Measured: This study comprises a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period (Day1 - Day4), and a safety follow-up period (Day7).
Evaluate the tolerability of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by Incidence of subject getting abnormal results of 12-lead ECG after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. 12-lead ECG will be analyzed by single RR Heart Rate, aggregate PR Interval, aggregate QRS Duration, aggregate RR Interval, aggregate QT Interval, aggregate QTC Interval. Normal range is provided by the site.
Measured: This study comprises a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period (Day1 - Day4), and a safety follow-up period (Day7).
Evaluate the tolerability of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by Incidence of subject getting abnormal results of laboratory tests after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Laboratory tests are composed of hematology, urinalysis, serum chemistry, coagulation test. Normal range is provided by the site.
Measured: This study comprises a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period (Day1 - Day4), and a safety follow-up period (Day7).
Evaluate the tolerability of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by the rates of adverse events after treatment.
An AE is defined as any untoward medical event that occurs after receiving a drug or treatment or any deterioration of a disease or symptom that existed before receiving the investigational product or treatment (excluding the disease studied in this trial) in a subject or a clinical investigation subject, whether or not considered related to the investigational product or treatment. Therefore, an AE can be a discomfort sign (including an abnormal laboratory finding), symptom, or transient disease beyond any indication, whether or not related to the investigational product or treatment. The investigator will name each AE reported during the study by MedDRA PT and evaluate their severity using the criteria of "mild", "moderate" and "severe". The relevance evaluation is divided into 5 grades: 1-certainly related; 2- probably/likely related; 3-possibly related; 4-unlikely related; 5 not related.
Measured: This study comprises a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period (Day1 - Day4), and a safety follow-up period (Day7).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start4 Feb 2025
- Primary completion20 Sep 2025
- Study completion20 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SafetyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurodawn Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770491
- Sponsor's protocol ID
- Y-3-LC-06
- Status last verified
- Dec 2025
- First submitted
- 24 Dec 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hill MD, Goyal M, Menon BK, Nogueira RG, McTaggart RA, Demchuk AM, Poppe AY, Buck BH, Field TS, Dowlatshahi D, van Adel BA, Swartz RH, Shah RA, Sauvageau E, Zerna C, Ospel JM, Joshi M, Almekhlafi MA, Ryckborst KJ, Lowerison MW, Heard K, Garman D, Haussen D, Cutting SM, Coutts SB, Roy D, Rempel JL, Rohr AC, Iancu D, Sahlas DJ, Yu AYX, Devlin TG, Hanel RA, Puetz V, Silver FL, Campbell BCV, Chapot R, Teitelbaum J, Mandzia JL, Kleinig TJ, Turkel-Parrella D, Heck D, Kelly ME, Bharatha A, Bang OY, Jadhav A, Gupta R, Frei DF, Tarpley JW, McDougall CG, Holmin S, Rha JH, Puri AS, Camden MC, Thomalla G, Choe H, Phillips SJ, Schindler JL, Thornton J, Nagel S, Heo JH, Sohn SI, Psychogios MN, Budzik RF, Starkman S, Martin CO, Burns PA, Murphy S, Lopez GA, English J, Tymianski M; ESCAPE-NA1 Investigators. Efficacy and safety of nerinetide for the treatment of acute ischaemic stroke (ESCAPE-NA1): a multicentre, double-blind, randomised controlled trial. Lancet. 2020 Mar 14;395(10227):878-887. doi: 10.1016/S0140-6736(20)30258-0. Epub 2020 Feb 20.
PubMed 32087818Chamorro A, Lo EH, Renu A, van Leyen K, Lyden PD. The future of neuroprotection in stroke. J Neurol Neurosurg Psychiatry. 2021 Feb;92(2):129-135. doi: 10.1136/jnnp-2020-324283. Epub 2020 Nov 4.
PubMed 33148815Campbell BCV, De Silva DA, Macleod MR, Coutts SB, Schwamm LH, Davis SM, Donnan GA. Ischaemic stroke. Nat Rev Dis Primers. 2019 Oct 10;5(1):70. doi: 10.1038/s41572-019-0118-8.
PubMed 31601801Wu H, Huang Z, Wang X, Chen M, Chen W, Hua Y, Ren J, Shen L, Song Y, Zhou Y, Luo C, Lin Y, Wang Y, Chang L, Li F, Zhu D. Preclinical evaluation of ZL006-05, a new antistroke drug with fast-onset antidepressant and anxiolytic effects. Stroke Vasc Neurol. 2023 Dec 29;8(6):463-474. doi: 10.1136/svn-2022-002156.
PubMed 37185136Xu X, Chen M, Zhu D. Reperfusion and cytoprotective agents are a mutually beneficial pair in ischaemic stroke therapy: an overview of pathophysiology, pharmacological targets and candidate drugs focusing on excitotoxicity and free radical. Stroke Vasc Neurol. 2024 Aug 27;9(4):351-359. doi: 10.1136/svn-2023-002671.
PubMed 37832977Fisher M; Stroke Therapy Academic Industry Roundtable. Recommendations for advancing development of acute stroke therapies: Stroke Therapy Academic Industry Roundtable 3. Stroke. 2003 Jun;34(6):1539-46. doi: 10.1161/01.STR.0000072983.64326.53. Epub 2003 May 15.
PubMed 12750546GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.
PubMed 34487721
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profiles of Y-3 in Healthy Adult Volunteers in the United States
- ClinicalTrials.gov ID
- NCT06770491
- Acronym / sponsor ID
- Y-3-LC-06
- Keywords
- safety, tolerability, Pharmacokinetic study in healthy volunteers, Y-3, stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Neurodawn Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 20 Sep 2025 (actual)
- Study completion
- 20 Sep 2025 (actual)
- First posted
- 13 Jan 2025 (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 goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetic profiles of Y-3 in healthy adult volunteers in the United States. The main questions it aims to answer are:
- What the pharmacokinetic profiles of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers?
- If drug Y-3 (40mg and 60 mg) is safe and tolerate in the US healthy adult volunteers.
Researchers will compare drug Y-3 (40 mg and 60 mg) to a placebo (a look-alike substance that contains no drug) to see what the pharmacokinetic profiles of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers and if drug Y-3 (40mg and 60 mg) is safe and tolerate in the US healthy adult volunteers.
Participants will:
- Take drug Y-3 (40 mg) or Y-3 (60 mg) or a placebo only once.
- Answer questions regarding your medical history.
- Comply with the study procedures and requests.
- Complete all tests and collections of PK Sampling.
- Must not have any special dietary requirements and be able to consume the food (low-fat) provided by Tranquil Clinical Research during your 4-night stay.
- Must avoid excessive ( > 8 cups per day) caffeine consumption (i.e. coffee or tea) during your time in the study.
- Must not consume any food or beverage rich in grapefruit, papaya, or mango during your time in the study.
- Must not take any other medications, including traditional Chinese medicines and herbal medicines, during your time in the study.
- Must avoid sexual activity or use non-drug contraceptive measures (i.e. condoms) during your time in the study.
- Female participants must not become pregnant while in the study.
- Must not receive any vaccinations during your time in the study.
- Must not donate blood for purposes outside of study procedures during your time in the study.
- Must not drink alcohol during your time in the study.
- Must not smoke during your time in the study.
- Inform your Study Doctor if you no longer wish to participate in the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Y-3 for injection (Y-3) | Experimental | Drug: Y-3 for injectionThe investigational drug (Y-3) consists of two parts: Y-3 for injection (lyophilized powder) （20 mg）and Solvent for Y-3 for injection (concentrated solution)（3ml (containing 0.6 g propylene glycol)）. Subjects will receive Y-3 or placebo on the morning of the dosing day. Drinking water is prohibited from 1 hour before administration until the end of dosing, and subjects may have meals 4 hours after administration. Using a sterile syringe, withdraw dedicated solution into the lyophilized powder vial of Y-3 or placebo. Shake the vial manually until the powder is dissolved. Once completely dissolved, use a sterile syringe to transfer the solution into the infusion bottle (normal saline) and gently mix by swirling. The intravenous infusion volume is 250 ml, and infusion time is 60 min ± 10 min. The storage time of the reconstituted drug product or placebo should not exceed 4 hours at room temperature or 24 hours at refrigerated temperature prior to initiation of administration. |
| placebo | Placebo comparator | Drug: PlaceboThe placebo consists of two parts: placebo (lyophilized powder) and Solvent for Y-3 for injection(concentrated solution). Subjects will receive Y-3 or placebo on the morning of the dosing day. Drinking water is prohibited from 1 hour before administration until the end of dosing, and subjects may have meals 4 hours after administration. Using a sterile syringe, withdraw dedicated solution into the lyophilized powder vial of Y-3 or placebo. Shake the vial manually until the powder is dissolved. Once completely dissolved, use a sterile syringe to transfer the solution into the infusion bottle (normal saline) and gently mix by swirling. The intravenous infusion volume is 250 ml, and infusion time is 60 min ± 10 min. The storage time of the reconstituted drug product or placebo should not exceed 4 hours at room temperature or 24 hours at refrigerated temperature prior to initiation of administration. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Medically documented as healthy at the time of screening as determined by their medical history, medical assessment, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory tests, etc.
- Within 18-45 years at the time of informed consent, inclusive.
- Body weight ≥ 50 kg for male and ≥ 45 kg for female, body mass index (BMI) within the range of 19 - 28 kg/m2, inclusive.
- Fully understand and provide a signed informed consent before performing any study-related procedures.
- Comply with the study and follow-up procedures.
Key exclusion criteria (17 listed)
- Known allergy to Y-3 or any of its excipients.
- Have disease history or current disease that may affect the safety evaluation of the subject or the internal process of the study drug, that the investigator judged to be of clinical significance, including the cardiovascular system, endocrine system, central nervous system, digestive system, respiratory system, hematological system, immunology, psychiatry, metabolic abnormalities, etc.
- Clinically significant abnormal 12-lead electrocardiograms (ECG) and vital signs judged by the investigator.
- Clinically significant abnormal laboratory tests (hematology, serum chemistry, coagulation, urinalysis, etc.) and other screening tests judged by the investigator.
- Test positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, syphilis antibody or human immunodeficiency virus (HIV) antibody.
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-3 for injectionThe investigational drug (Y-3) consists of two parts: Y-3 for injection (lyophilized powder) and Solvent for Y-3 for injection (concentrated solution). Name: Y-3 for injection Strength: 20 mg Dosage Form: Lyophilized powder for injection Storage Condition: 2-8°C Supplier: Neurodawn Pharmaceutical Co., Ltd. Name: Reconstitution diluent for Y-3 for injection Strength: 3ml (containing 0.6 g propylene glycol) Dosage Form: Concentrated solution for injection Storage Condition: 2-8°C Supplier: Neurodawn Pharmaceutical Co., Ltd. | Drug | Y-3 for injection (Y-3) |
| PlaceboThe placebo consists of two parts: placebo (lyophilized powder) and Solvent for Y-3 for injection(concentrated solution). Name: Placebo Strength: 0 mg Dosage Form: Lyophilized powder for injection Storage Condition: 2-8°C Supplier: Neurodawn Pharmaceutical Co., Ltd. Name: Solvent for Y-3 for injection Strength: 3 mL (containing 0.6 g propylene glycol) Dosage Form: Concentrated solution for injection Storage Condition: 2-8°C Supplier: Neurodawn Pharmaceutical Co., Ltd. | Drug | placebo |
Primary outcome
Evaluate the Cmax of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin
Time frame: treatment period (Day1-Day4)
Maximum observed plasma concentration. It was obtained directly from the measured plasma concentration-time data.
Evaluate the AUC 0-t of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Time frame: treatment period (Day1-Day4)
Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration. Calculated according to linearity trapezoidal rule: AUC (i, i+1) = (Ti+1-Ti) (Ci+Ci+1) /2, and AUC0-t is the sum of all AUC (i, i + 1).
Evaluate the AUC 0-∞ of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Time frame: treatment period (Day1-Day4)
Area under the concentration-time curve from time 0 to infinity (extrapolated). AUC 0-∞ =AUC 0-t + Ct/λz (Ct is the last measured plasma concentration).
Evaluate the Tmax of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Time frame: treatment period (Day1-Day4)
Time to reach maximum observed plasma concentration. It was obtained directly from the measured plasma concentration-time data.
Evaluate the t1/2 of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Time frame: treatment period (Day1-Day4)
Terminal elimination half-life. t1/2 = ln2/λ。
Evaluate the λz of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Time frame: treatment period (Day1-Day4)
Terminal-phase elimination rate constant, slope of curves terminal segment at semi-log concentration-time curve calculated by linear regression.
Evaluate the AUC_%Extrap of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Time frame: treatment period (Day1-Day4)
The percentage of the AUC0-inf that has been extrapolated. AUC_%Extrap = [(AUC0-∞-AUC0-t)/AUC0-∞] × 100%
Evaluate the Vz of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Time frame: treatment period (Day1-Day4)
Volume of distribution. Vz = Div/AUC0-∞/λz
Evaluate the CL of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Time frame: treatment period (Day1-Day4)
Total body clearance. CLz = Div /AUC0-∞
Evaluate the MRT 0-t of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Time frame: treatment period (Day1-Day4)
Mean residence time within the time from time zero to the lowest testing plasma concentration. MRT0-t = AUMC0-t/AUC0-t.
Evaluate the MRT 0-∞ of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Time frame: treatment period (Day1-Day4)
Mean residence time extrapolated from zero to infinity. MRT 0-∞ = AUMC 0-∞/AUC 0-∞.
10 secondary outcomes
Evaluate the safety of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by Incidence of subject getting abnormal results of physical examinations after treatment.
Time frame: This study comprises a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period (Day1 - Day4), and a safety follow-up period (Day7).
Evaluate the safety of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by Incidence of subject getting abnormal results of vital signs after treatment.
Time frame: This study comprises a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period (Day1 - Day4), and a safety follow-up period (Day7).
Evaluate the safety of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by Incidence of subject getting abnormal results of 12-lead ECG after treatment.
Time frame: This study comprises a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period (Day1 - Day4), and a safety follow-up period (Day7).
Evaluate the safety of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by Incidence of subject getting abnormal results of laboratory tests after treatment.
Time frame: This study comprises a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period (Day1 - Day4), and a safety follow-up period (Day7).
Evaluate the safety of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by the rates of adverse events after treatment.
Time frame: This study comprises a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period (Day1 - Day4), and a safety follow-up period (Day7).
Evaluate the tolerability of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by Incidence of subject getting abnormal results of physical examinations after treatment.
Time frame: This study comprises a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period (Day1 - Day4), and a safety follow-up period (Day7).
Evaluate the tolerability of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by Incidence of subject getting abnormal results of vital signs after treatment.
Time frame: This study comprises a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period (Day1 - Day4), and a safety follow-up period (Day7).
Evaluate the tolerability of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by Incidence of subject getting abnormal results of 12-lead ECG after treatment.
Time frame: This study comprises a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period (Day1 - Day4), and a safety follow-up period (Day7).
Evaluate the tolerability of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by Incidence of subject getting abnormal results of laboratory tests after treatment.
Time frame: This study comprises a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period (Day1 - Day4), and a safety follow-up period (Day7).
Evaluate the tolerability of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by the rates of adverse events after treatment.
Time frame: This study comprises a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period (Day1 - Day4), and a safety follow-up period (Day7).
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 18 Dec 2025.
- Results publication: PubMed 32087818Hill MD, Goyal M, Menon BK, Nogueira RG, McTaggart RA, Demchuk AM, Poppe AY, Buck BH, Field TS, Dowlatshahi D, van Adel BA, Swartz RH, Shah RA, Sauvageau E, Zerna C, Ospel JM, Joshi M, Almekhlafi MA, Ryckborst KJ, Lowerison MW, Heard K, Garman D, Haussen D, Cutting SM, Coutts SB, Roy D, Rempel JL, Rohr AC, Iancu D, Sahlas DJ, Yu AYX, Devlin TG, Hanel RA, Puetz V, Silver FL, Campbell BCV, Chapot R, Teitelbaum J, Mandzia JL, Kleinig TJ, Turkel-Parrella D, Heck D, Kelly ME, Bharatha A, Bang OY, Jadhav A, Gupta R, Frei DF, Tarpley JW, McDougall CG, Holmin S, Rha JH, Puri AS, Camden MC, Thomalla G, Choe H, Phillips SJ, Schindler JL, Thornton J, Nagel S, Heo JH, Sohn SI, Psychogios MN, Budzik RF, Starkman S, Martin CO, Burns PA, Murphy S, Lopez GA, English J, Tymianski M; ESCAPE-NA1 Investigators. Efficacy and safety of nerinetide for the treatment of acute ischaemic stroke (ESCAPE-NA1): a multicentre, double-blind, randomised controlled trial. Lancet. 2020 Mar 14;395(10227):878-887. doi: 10.1016/S0140-6736(20)30258-0. Epub 2020 Feb 20.
- Results publication: PubMed 33148815Chamorro A, Lo EH, Renu A, van Leyen K, Lyden PD. The future of neuroprotection in stroke. J Neurol Neurosurg Psychiatry. 2021 Feb;92(2):129-135. doi: 10.1136/jnnp-2020-324283. Epub 2020 Nov 4.
- Results publication: PubMed 31601801Campbell BCV, De Silva DA, Macleod MR, Coutts SB, Schwamm LH, Davis SM, Donnan GA. Ischaemic stroke. Nat Rev Dis Primers. 2019 Oct 10;5(1):70. doi: 10.1038/s41572-019-0118-8.
- Results publication: PubMed 37185136Wu H, Huang Z, Wang X, Chen M, Chen W, Hua Y, Ren J, Shen L, Song Y, Zhou Y, Luo C, Lin Y, Wang Y, Chang L, Li F, Zhu D. Preclinical evaluation of ZL006-05, a new antistroke drug with fast-onset antidepressant and anxiolytic effects. Stroke Vasc Neurol. 2023 Dec 29;8(6):463-474. doi: 10.1136/svn-2022-002156.
- Results publication: PubMed 37832977Xu X, Chen M, Zhu D. Reperfusion and cytoprotective agents are a mutually beneficial pair in ischaemic stroke therapy: an overview of pathophysiology, pharmacological targets and candidate drugs focusing on excitotoxicity and free radical. Stroke Vasc Neurol. 2024 Aug 27;9(4):351-359. doi: 10.1136/svn-2023-002671.
- Results publication: PubMed 12750546Fisher M; Stroke Therapy Academic Industry Roundtable. Recommendations for advancing development of acute stroke therapies: Stroke Therapy Academic Industry Roundtable 3. Stroke. 2003 Jun;34(6):1539-46. doi: 10.1161/01.STR.0000072983.64326.53. Epub 2003 May 15.
- Results publication: PubMed 34487721GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.
- Individual participant dataSharing planned: No
Related trials for Safety
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
The record lists no contact. Use the official record to reach the sponsor.
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-3 for injection in people with Safety and Tolerability, run by Neurodawn Pharmaceutical 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 5 inclusion and 17 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 18 Dec 2025. 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. Some participants in this study may receive a placebo. 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?
Evaluate the Cmax of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin (time frame: treatment period (Day1-Day4)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06770491, which also lists 7 linked publications.
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 18 Dec 2025.