Healthy Male and Female SubjectsPhase 1NCT07618715
Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in U.S. Healthy Participants
A Phase 1 study testing Y-4 tablet, Pregabalin capsule and Riluzole tablet in people with Healthy Male and Female Subjects, run by Neurodawn Pharmaceutical Co., Ltd. at 1 site in United States.
Trial summary
The primary goal of this clinical trial is to compare pharmacokinetic characteristics of Y-4 tablets with pregabalin capsules and riluzole tablets in the US healthy adult participants after single oral administration under fasted condition. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Male and Female Subjects
- What is being tested?
- Y-4 tablet, Pregabalin capsule and Riluzole tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2026to 31 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Healthy adult male and female participants, 18-45 years of age (including both ends).
- Body weight ≥ 50 kg for male and ≥ 45 kg for female, body mass index (BMI) within the range of 19 - 28 kg/m2 (including both ends).
- During the screening period, serum creatinine is within the normal range, or the standard creatinine clearance (CLcr) estimated by Cockcroft-Gault formula is ≥ 80 mL/min (for female participant, according to the calculation result × 0.85）
- Participants who are able to understand and give their signed informed consent before any trial related procedures are performed.
Who cannot join
- Participants who are known to be allergic to pregabalin, riluzole or any excipients of Y-4 tablets (microcrystalline cellulose, copovidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, Opadry amb Ⅱ), have allergic diseases or allergic constitution;
- Participants who have special requirements for diet and cannot follow the unified diet;
- Physical examinations, vital signs, 12-lead electrocardiograms (ECG), laboratory tests (Hematology, serum chemistry, coagulation test, urinalysis, etc.) and other screening tests found abnormalities that the researchers judged to be of clinical significance;
- Participants who have experienced angioedema in the past (such as swelling of the face, mouth (tongue, lips, and gums), and neck (pharynx and throat));
- History of dizziness or vertigo with clinical significance, or disease of inner ear known to cause dizziness or vertigo;
- QTcF > 450 msec at the screening stage (Corrected using Fridericia's formula: QTcF = QT /(RR^0.33), where RR = 60 / heart rate);
Show all 24Show fewer
- Diagnosed with insomnia, anxiety disorder, depression, epilepsy, or other serious mental disorders, and principal investigator determines that the participant is not suitable to participate in this trial;
- Presence or history of hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of medicines, participants who have impaired hepatic function at the time of screening: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 ULN; or total bilirubin (TBIL) > 1.0 ULN;
- Participants who 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 disagree that any caffeine-containing beverages are prohibited during the trial;
- Participants who have consume any diet (food or beverage) rich in grapefruit, pitaya, mango and cranberry within 14 days prior to screening;
- Participants have disease history or current disease that may affect the safety evaluation of the participant or the internal process of the study drug, including the central nervous system, cardiovascular system, digestive system, endocrine system, respiratory system, urinary system, hematological system, immunology, psychiatry, metabolic abnormalities, gastrointestinal surgery (excluding appendicitis surgery), etc. In particular, there is a history of dysphagia or any gastrointestinal disease affecting drug absorption (including frequent nausea or vomiting caused by any cause) and eye diseases;
- Donation or loss of blood equal to or in excess of 400 mL, or blood transfusion within 3 months prior to screening; or donation or loss of blood equal to or in excess of 200 mL within 1 month prior to screening;
- Participants who have taken any drugs known to be strong inhibitors or inducers of cytochrome P450 enzymes within 2 months prior to screening (such as inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - serotonin reuptake inhibitors (SSRI) antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); or participants who have taken any prescription drugs, over-the-counter drugs and traditional Chinese medicine or herbal medicine other than the above drugs within 14 days prior to screening;
- Participants who have taken central nervous system (CNS) depressants including opioids (pethidine hydrochloride, morphine, dihydromorphine hydrochloride, fentanyl, Tramadol, etc), benzodiazepines (diazepam, flurazepam, clonazepam, oxazepam, chlordiazepine and triazolam etc), antiepileptic drugs (carbamazepine, sodium valproate, phenobarbital drugs etc) within 2 months prior to screening;
- Participant with sleep apnea, or participants with severe sleep snoring and daytime drowsiness;
- Participants with history of neuropsychiatric disorders, including current or past history of mental illness, suicidal ideation based on the C-SSRS score of 1 or higher;
- Participant participated in any other clinical trials within 3 months prior to screening;
- Current or former drug users, or positive urine screen for drugs of abuse at screening (screening items include: Opiates, Amphetamines, Cocaine, Cannabinoids, Barbiturates, Benzodiazepines);
- Alcoholics or regular drinkers within 3 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 trial;
- Smokers or those who cannot comply with the prohibition of smoking during the trial, or positive for cotinine screening;
- Participants who is positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, syphilis antibody or human immunodeficiency virus (HIV) antibody;
- Male participants (or their partners) or female participants have baby plans during the whole trial period and within 3 months after the end of the trail, or participants are unwilling to take one or more non-drug contraceptive measures (such as complete abstinence, condoms, ligation, etc.) during the trial period.
- Female participants who have unprotected intercourse within 14 days prior to screening, or pregnant or lactating women;
- Participants with poor compliance or other factors unsuitable for participation in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Frontage Clinical Services,Inc.
Secaucus, New Jersey, 07094
Frank Lee, (201)416-7753, flee@frontagelab.com
About this study
Official title: An Open-label, Single-dose, Three-period Phase Ⅰ Study to Compare the Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in U.S. Healthy Participants
The primary goal of this clinical trial is to compare pharmacokinetic characteristics of Y-4 tablets with pregabalin capsules and riluzole tablets in the US healthy adult participants after single oral administration under fasted condition.
The secondary goal of the trial is to evaluate the safety and tolerability of Y-4 tablets, pregabalin capsules and riluzole tablets in the US healthy adult participants.
Read the detailed description
This study will be an open-label, single-dose, three-period study in healthy adult participants. A total of at least 10 participants (about half men and half women) will be will be enrolled and needed to complete in the study. Participants enrolled in this study wil be administered with Y-4 tablets, pregabalin capsules and riluzole tablets at three periods with a 7-day washout.
Periods and corresponding treatments are planned as following:
Period 1: Y-4 tablet, one tablet, 112.5 mg/28.125 mg (pregabalin/riluzole) Period 2: pregabalin capsule, one capsule, 75 mg/capsule Period 3: riluzole tablet, one tablet, 50 mg/tablet
- Conditions
- Healthy Male and Female Subjects
- Being tested
- Y-4 tablet, Pregabalin capsule, Riluzole tablet
- Keywords
- Phase Ⅰ, Y-4 Tablet, Postherpetic Neuralgia
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y-4 tabletDrug
Participants will be admitted to research center on Day-1. Participants are required to fast for at least 10 hours prior to dosing on Day 1. In the morning of Day 1, participants will be administered with one tablet of Y-4 (pregabalin 112.5 mg and riluzole 28.125 mg), then participants will be monitored and blood samples will be collected for the following 72 hours (Day4).
Pregabalin capsuleDrug
Participants are required to fast for at least 10 hours prior to dosing on Day 8. In the morning of Day 8, participants will be administered with one pregabalin capsule (75 mg pregabalin), then participants will be monitored and blood samples will be collected for the following 72 hours (Day 11).
Riluzole tabletDrug
Participants are required to fast for at least 10 hours prior to dosing on Day 15. In the morning of Day 15, participants will be administered with one riluzole tablet (50 mg riluzole), then participants will be monitored and blood samples will be collected for the following 72 hours (Day 18).
| Study group | Role | What they receive |
|---|---|---|
| Y-4 tables | Experimental | In the morning of Day 1 ，single oral administration one Y-4 tablet in the state of fasting state. Receives: Drug: Y-4 tablet |
| Pregabalin capsule | Experimental | In the morning of Day 8 ，single oral administration one pregabalin capsule in the state of fasting state. Receives: Drug: Pregabalin capsule |
| Riluzole tablet | Experimental | In the morning of Day 15 ，single oral administration one riluzole tablet in the state of fasting state. Receives: Drug: Riluzole tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed concentration, it was obtained directly from the measured plasma concentration-time data;
Measured: On Day1-4、Day8-11、Day15-18 of observation period.
AUC0-t
Area under the concentration-time curve from time zero to the last detectable concentration
Measured: On Day1-4、Day8-11、Day15-18 of observation period.
AUC0-∞
Area under the concentration-time curve from time 0 to infinity (extrapolated).
Measured: On Day1-4、Day8-11、Day15-18 of observation period.
Secondary outcomes (15)
Tmax
Time of observed Cmax, it was obtained directly from the measured plasma concentration-time data;
Measured: On Day1-4、Day8-11、Day15-18 of observation period.
λz
Terminal-phase elimination rate constant, slope of curves terminal segment at semi-log concentration-time curve calculated by linear regression;
Measured: On Day1-4、Day8-11、Day15-18 of observation period.
t1/2
Terminal elimination half-life
Measured: On Day1-4、Day8-11、Day15-18 of observation period.
CL/F
Apparent total body clearance
Measured: On Day1-4、Day8-11、Day15-18 of observation period.
Vz/F
Apparent volume of distribution
Measured: On Day1-4、Day8-11、Day15-18 of observation period.
MRT0-t
Mean residence time within the time from time zero to the lowest testing plasma concentration
Measured: On Day1-4、Day8-11、Day15-18 of observation period.
MRT0-∞
Mean residence time extrapolated from zero to infinity
Measured: On Day1-4、Day8-11、Day15-18 of observation period.
AUC_%Extrap
The percentage of the AUC0-inf that has been extrapolated.
Measured: On Day1-4、Day8-11、Day15-18 of observation period.
The Incidence of subject getting abnormal results of clinical 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. All AEs will be coded using the MedDRA, and summarized by SOC and PT. Number and percentage of participants with AEs,SAEs, and AEs that lead to early withdrawal will be summarized. AEs might be summarized by severity (grade) and relationship to investigational product if judged appropriate.
Measured: From the first day to the 25th± 1st day after the start of administration
The 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.Clinical laboratory examinations including hematology, serum chemistry, ,urinalysis,coagulation test (PT/APTT/FIB/TT).Normal range is provided by the site.
Measured: From the first day to the 25th± 1st day after the start of administration
The Incidence of subject getting abnormal results of 12-lead electrocardiograms after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment.Standard ECG parameters will be measured including RR, PR, and QTc intervals, and QRS duration .Normal range is provided by the site.
Measured: From the first day to the 25th± 1st day after the start of administration
The 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, including blood pressure (sitting position), pulse rate, temperature (frontal temperature, Celsius), and respiration.Normal range is provided by the site.
Measured: From the first day to the 25th± 1st day after the start of administration
The Incidence of subject getting abnormal results of blood oxygen saturation after treatment.
Record changes of blood oxygen saturation from baseline to post-treatment, listing deviations from normal ranges post-treatment. Normal range is provided by the site
Measured: From the first day to the 25th± 1st day after the start of administration
The 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. The physical examinations will consist of a general assessment, dermatologic, lymph nodes, head, eyes, ears, nose, throat, chest, neck, thyroid gland, cardiac, lung, chest (included breast), abdomen, extremities, musculoskeletal, neurologic, and other physical findings of note. Normal range is provided by the site.
Measured: From the first day to the 25th± 1st day after the start of administration
The Incidence of subject getting abnormal results of C-SSRS scale evaluation after treatment.
Record changes of C-SSRS scale evaluation from baseline to post-treatment.
Measured: From the first day to the 25th± 1st day after the start of administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male and Female SubjectsStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 11 participants (estimated)
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
- NCT07618715
- Sponsor's protocol ID
- Y-4-LC-02 (US)
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose, Three-period Phase Ⅰ Study to Compare the Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in U.S. Healthy Participants
- ClinicalTrials.gov ID
- NCT07618715
- Acronym / sponsor ID
- Y-4-LC-02 (US)
- Conditions
- Healthy Male and Female Subjects
- Keywords
- Phase Ⅰ, Y-4 Tablet, Postherpetic Neuralgia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Neurodawn Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 1 Jun 2026 (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 goal of this clinical trial is to compare pharmacokinetic characteristics of Y-4 tablets with pregabalin capsules and riluzole tablets in the US healthy adult participants after single oral administration under fasted condition.
The secondary goal of the trial is to evaluate the safety and tolerability of Y-4 tablets, pregabalin capsules and riluzole tablets in the US healthy adult participants.
Detailed description
This study will be an open-label, single-dose, three-period study in healthy adult participants. A total of at least 10 participants (about half men and half women) will be will be enrolled and needed to complete in the study. Participants enrolled in this study wil be administered with Y-4 tablets, pregabalin capsules and riluzole tablets at three periods with a 7-day washout.
Periods and corresponding treatments are planned as following:
Period 1: Y-4 tablet, one tablet, 112.5 mg/28.125 mg (pregabalin/riluzole) Period 2: pregabalin capsule, one capsule, 75 mg/capsule Period 3: riluzole tablet, one tablet, 50 mg/tablet
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Y-4 tables | Experimental | Drug: Y-4 tabletIn the morning of Day 1 ，single oral administration one Y-4 tablet in the state of fasting state. |
| Pregabalin capsule | Experimental | Drug: Pregabalin capsuleIn the morning of Day 8 ，single oral administration one pregabalin capsule in the state of fasting state. |
| Riluzole tablet | Experimental | Drug: Riluzole tabletIn the morning of Day 15 ，single oral administration one riluzole tablet in the state of fasting state. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult male and female participants, 18-45 years of age (including both ends).
- Body weight ≥ 50 kg for male and ≥ 45 kg for female, body mass index (BMI) within the range of 19 - 28 kg/m2 (including both ends).
- During the screening period, serum creatinine is within the normal range, or the standard creatinine clearance (CLcr) estimated by Cockcroft-Gault formula is ≥ 80 mL/min (for female participant, according to the calculation result × 0.85）
- Participants who are able to understand and give their signed informed consent before any trial related procedures are performed.
Key exclusion criteria (24 listed)
- Participants who are known to be allergic to pregabalin, riluzole or any excipients of Y-4 tablets (microcrystalline cellulose, copovidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, Opadry amb Ⅱ), have allergic diseases or allergic constitution;
- Participants who have special requirements for diet and cannot follow the unified diet;
- Physical examinations, vital signs, 12-lead electrocardiograms (ECG), laboratory tests (Hematology, serum chemistry, coagulation test, urinalysis, etc.) and other screening tests found abnormalities that the researchers judged to be of clinical significance;
- Participants who have experienced angioedema in the past (such as swelling of the face, mouth (tongue, lips, and gums), and neck (pharynx and throat));
- History of dizziness or vertigo with clinical significance, or disease of inner ear known to cause dizziness or vertigo;
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-4 tabletParticipants will be admitted to research center on Day-1. Participants are required to fast for at least 10 hours prior to dosing on Day 1. In the morning of Day 1, participants will be administered with one tablet of Y-4 (pregabalin 112.5 mg and riluzole 28.125 mg), then participants will be monitored and blood samples will be collected for the following 72 hours (Day4). | Drug | Y-4 tables |
| Pregabalin capsuleParticipants are required to fast for at least 10 hours prior to dosing on Day 8. In the morning of Day 8, participants will be administered with one pregabalin capsule (75 mg pregabalin), then participants will be monitored and blood samples will be collected for the following 72 hours (Day 11). | Drug | Pregabalin capsule |
| Riluzole tabletParticipants are required to fast for at least 10 hours prior to dosing on Day 15. In the morning of Day 15, participants will be administered with one riluzole tablet (50 mg riluzole), then participants will be monitored and blood samples will be collected for the following 72 hours (Day 18). | Drug | Riluzole tablet |
Primary outcome
Cmax
Time frame: On Day1-4、Day8-11、Day15-18 of observation period.
Maximum observed concentration, it was obtained directly from the measured plasma concentration-time data;
AUC0-t
Time frame: On Day1-4、Day8-11、Day15-18 of observation period.
Area under the concentration-time curve from time zero to the last detectable concentration
AUC0-∞
Time frame: On Day1-4、Day8-11、Day15-18 of observation period.
Area under the concentration-time curve from time 0 to infinity (extrapolated).
15 secondary outcomes
Tmax
Time frame: On Day1-4、Day8-11、Day15-18 of observation period.
λz
Time frame: On Day1-4、Day8-11、Day15-18 of observation period.
t1/2
Time frame: On Day1-4、Day8-11、Day15-18 of observation period.
CL/F
Time frame: On Day1-4、Day8-11、Day15-18 of observation period.
Vz/F
Time frame: On Day1-4、Day8-11、Day15-18 of observation period.
MRT0-t
Time frame: On Day1-4、Day8-11、Day15-18 of observation period.
MRT0-∞
Time frame: On Day1-4、Day8-11、Day15-18 of observation period.
AUC_%Extrap
Time frame: On Day1-4、Day8-11、Day15-18 of observation period.
The Incidence of subject getting abnormal results of clinical adverse events after treatment.
Time frame: From the first day to the 25th± 1st day after the start of administration
The Incidence of subject getting abnormal results of laboratory tests after treatment.
Time frame: From the first day to the 25th± 1st day after the start of administration
The Incidence of subject getting abnormal results of 12-lead electrocardiograms after treatment.
Time frame: From the first day to the 25th± 1st day after the start of administration
The Incidence of subject getting abnormal results of vital signs after treatment
Time frame: From the first day to the 25th± 1st day after the start of administration
The Incidence of subject getting abnormal results of blood oxygen saturation after treatment.
Time frame: From the first day to the 25th± 1st day after the start of administration
The Incidence of subject getting abnormal results of physical examinations after treatment.
Time frame: From the first day to the 25th± 1st day after the start of administration
The Incidence of subject getting abnormal results of C-SSRS scale evaluation after treatment.
Time frame: From the first day to the 25th± 1st day after the start of administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Male and Female Subjects
RecruitingPhase 1
A Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Subjects With Normal Renal Function
Participants With Moderate and Severe Renal Impairment and Healthy Participants
RecruitingPhase 1
Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
RecruitingObservational study
Urinary Vitamin C Loss in Diabetic Subjects
Diabetes
Active, not recruitingPhase 1/2
A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment
Hypothalamic Obesity, Prader-Willi Syndrome
Recruiting
Nicotinamide Mononucleotide Supplementation for Exercise Tolerance Improvement in Healthy Older Adults
Aging, Frailty
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.
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-4 tablet, Pregabalin capsule and Riluzole tablet in people with Healthy Male and Female Subjects, 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 4 inclusion and 24 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: opening soon, as of the sponsor's last update on 1 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frank Lee ((201)416-7753, flee@frontagelab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: On Day1-4、Day8-11、Day15-18 of observation period.). The study lists 3 primary outcomes in all. 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 1 Jun 2026.