Healthy Adult Male and Female VolunteersPhase 1NCT06935682
Safety and Pharmacokinetics of Y-4 Tablets in Healthy Subjects
A Phase 1 study testing Y-4 tables in people with Healthy Adult Male and Female Volunteers, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Y-4 is a new fixed-dose combination drug product containing two active ingredients of pregabalin and riluzole. The primary objective is to evaluate the safety and tolerability of Y-4 tablets in Chinese healthy adult subjects after single- and multiple-dose. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male and Female Volunteers
- What is being tested?
- Y-4 tables
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2025to 30 Jun 2025
- 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 subjects, 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 subject, according to the calculation result × 0.85）.
- Subjects who are able to understand and give their signed informed consent before any trial related procedures are performed.
Who cannot join
- Subjects 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 and Opadry amb Ⅱ), have allergic diseases or allergic constitution;
- Subjects who have special requirements for diet and cannot follow the unified diet;
- Physical examinations, vital signs, 12-lead electrocardiograms (ECG), chest X-ray (front position), laboratory tests (hematology, serum chemistry, coagulation test, urinalysis, etc.) and other screening tests found abnormalities that the researchers judged to be of clinical significance;
- Subjects 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;
Show all 24Show fewer
- Diagnosed with insomnia, anxiety disorder, depression, epilepsy, or other serious mental disorders, and principal investigator determines that the subject 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;
- Subjects 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;
- Subjects who have consume any diet (food or beverage) rich in grapefruit, pitaya, mango and cranberry within 14 days prior to screening;
- Subjects have disease history or current disease that may affect the safety evaluation of the subject or the internal process of the study drug, including the central nervous system, cardiovascular system, digestive 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;
- Subjects 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 subjects who have taken any prescription drugs, over-the-counter drugs and Chinese herbal medicine other than the above drugs within 14 days prior to screening;
- Subjects 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;
- Subject with sleep apnea, or subjects with severe sleep snoring and daytime drowsiness;
- Subjects with suicidal thoughts and behavior;
- Subject 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: dimethylenedioxyamphetamine, methamphetamine, ketamine, morphine, tetrahydrocannabinoid acid, cocaine);
- 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;
- Subjects who is positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, syphilis antibody or human immunodeficiency virus (HIV) antibody;
- 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 trial period;
- Female subjects who have unprotected intercourse within 14 days prior to screening, or pregnant or lactating women;
- Subjects 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.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University Beijing
Beijing, Beijing Municipality, 100000
Shuya Li, M.D., +8613601367028, shuyali85@163.com
Shuya Li
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase 1 Study to Assess the Safety and Pharmacokinetics of Y-4 Tablets After Single- and Multiple-dose in Healthy Subjects
Y-4 is a new fixed-dose combination drug product containing two active ingredients of pregabalin and riluzole.
The primary objective is to evaluate the safety and tolerability of Y-4 tablets in Chinese healthy adult subjects after single- and multiple-dose.
The secondary objective is to characterize the pharmacokinetics (PK) of pregabalin and riluzole in Chinese healthy adult subjects after single- and multiple-dose of Y-4 tablets.
Read the detailed description
This study will be a single-center, randomized, double-blind, placebo-controlled, dose-escalation study in Chinese healthy adult subjects. A total of 36 subjects, 3 cohorts of 12 subjects each (half men and half women), will be enrolled in this study. In each dose cohort, subjects will undergo single and multiple (BID, 11 doses) administration, among them, 10 subjects (half men and half women) will receive Y-4 tablets and 2 subjects (half men and half women) will receive placebo randomly.
After providing written informed consent, subjects will undergo screening for eligibility. Screening for the study will begin 14 days prior to the dosing. Subjects will be admitted to research center in the afternoon of Day-1 prior to the dosing day and fasting for the next 10 hours overnight. In the morning of the following day (Day 1), subjects will be administered the assigned dose of Y-4 tablets or placebo orally, then subjects will be monitored for the following 72 hours. During Day 5 to Day 9, the subjects will be required to be administered twice a day (Q12 h), once in the morning and once in the evening. In the morning of Day 10, subjects will be administered to the last dose. In the morning of Day 13 (approximately 72 hours after the last administration), the safety and tolerance will be evaluated and then subjects will be discharged.
A telephone follow-up/completion visit will be conducted 7 days (±1) post discharge.
Treatment cohorts are planned as following:
Cohort 1: 75 mg/18.75 mg Y-4 tablets (75 mg pregabalin and 18.75 mg riluzole) or placebo tablets (two little Y-4 tablets) Cohort 2: 112.5 mg/28.125 mg Y-4 tablets (112.5 mg pregabalin and 28.125 mg riluzole) or placebo tablets (one large Y-4 tablet) Cohort 3: 150 mg/37.5 mg Y-4 tablets (150 mg pregabalin and 37.5 mg riluzole) or placebo tablets (one large Y-4 tablet and one little Y-4 tablet)
- Conditions
- Healthy Adult Male and Female Volunteers
- Being tested
- Y-4 tables, Y-4 placebos
- Keywords
- phase I trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y-4 tablesDrug
Each subject will receive a single dose and multiple doses. During the single dose phase (Day1-Day4), the subjects will be administered with single dose of Y-4 tablets on fasting state in the morning of Day D1. During the multiple dosing phase (Day5-Day13), the subjects will be required to administer with Y-4 tablets continuously for 6 days, BID of Day5-Day9 (once in the morning and once in the evening, Q12h) and QD of Day10, for a total of 11 doses.
Y-4 placebosDrug
Each subject will receive a single dose and multiple doses. During the single dose phase (Day1-Day4), the subjects will be administered with single dose of Y-4 placebos on fasting state in the morning of Day D1. During the multiple dosing phase (Day5-Day13), the subjects will be required to administer with Y-4 placebos continuously for 6 days, BID of Day5-Day9 (once in the morning and once in the evening, Q12h) and QD of Day10, for a total of 11 doses.
| Study group | Role | What they receive |
|---|---|---|
| Y-4 tables | Experimental | Each subject will receive a single dose and multiple doses. Receives: Drug: Y-4 tables |
| Y-4 placebos | Placebo comparator | Each subject will receive a single dose and multiple doses. Receives: Drug: Y-4 placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events
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: From the first day to the 19th± 1st day after the start of administration
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: From the first day to the 19th± 1st day after the start of administration
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: From the first day to the 19th± 1st day after the start of administration
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(body temperature, respiration, blood pressure, and pulse) will be assessed by according equipment.(electronic sphygmomanometer, thermometer).
Measured: From the first day to the 19th± 1st day after the start of administration
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: From the first day to the 19th± 1st day after the start of administration
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 19th± 1st day after the start of administration
Incidence of subject getting abnormal results of C-SSSRS scale evaluation after treatment after treatment
Record changes of C-SSSRS scale evaluation from baseline to post-treatment
Measured: From the first day to the 19th± 1st day after the start of administration
Secondary outcomes (22)
Cmax
peak plasma concentration after single dose
Measured: From day 1 to day 4 after the start of administration
AUC0-t
Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration after single dose
Measured: From day 1 to day 4 after the start of administration
AUC0-∞
Area under the plasma concentration-time curve from time 0 to infinity (extrapolated) after single dose
Measured: From day 1 to day 4 after the start of administration
Tmax
Time to reach maximum observed plasma concentration after single dose
Measured: From day 1 to day 4 after the start of administration
t1/2
Terminal elimination half-life after single dose
Measured: From day 1 to day 4 after the start of administration
λz
Terminal-phase elimination rate constant, slope of curves terminal segment at semi-log concentration-time curve calculated by linear regression.
Measured: From day 1 to day 4 and from day 8 to day 13 after the start of administration
AUC_%Extrap
The percentage of the AUC0-inf that has been extrapolated. AUC_%Extrap = [(AUC0-∞-AUC0-t)/AUC0-∞] × 100%
Measured: From day 1 to day 4 and from day 8 to day 13 after the start of administration
CL/F
Total body clearance after single dose. CL/F = Dose/AUC0-inf
Measured: From day 1 to day 4 after the start of administration
Vz/F
apparent volume of distribution after single dose. Vz/F = Dose/AUC0-∞/λz
Measured: From day 1 to day 4 after the start of administration
MRT0-t
Mean residence time within the time from time zero to the lowest testing plasma concentration after single dose. MRT0-t = AUMC0-t/AUC0-t
Measured: From day 1 to day 4 after the start of administration
MRT0-∞
Mean residence time extrapolated from zero to infinity after single dose. MRT 0-∞ = AUMC 0-∞/AUC 0-∞.
Measured: From day 1 to day 4 after the start of administration
Cav, ss
mean plasma concentration at steady state
Measured: From day 8 to day 13 after the start of administration
Cmax, ss
Cmax at steady state
Measured: From day 8 to day 13 after the start of administration
Cmin, ss
minimal plasma concentration at steady state
Measured: From day 8 to day 13 after the start of administration
AUCτ
Area under the concentration-time curve between dosing interval at steady state
Measured: From 8 to day 13 after the start of administration
AUC0-t, ss
AUC0-t at steady state
Measured: From day 8 to day 13 after the start of administration
AUC0-∞, ss
AUC0-∞ at steady state
Measured: From day 8 to day 13 after the start of administration
Tmax, ss
Tmax at steady state
Measured: From day 8 to day 13 after the start of administration
t1/2, ss
t1/2 at steady state
Measured: From day 8 to day 13 after the start of administration
CLss/F
CL/F at steady state
Measured: From day 8 to day 13 after the start of administration
Vz, ss/F
Vz/F at steady state
Measured: From day 8 to day 13 after the start of administration
DF
degree of fluctuation of plasma concentration
Measured: From day 8 to day 13 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 posted20 Apr 2025
- Study start4 Jan 2025
- Primary completion4 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult Male and Female VolunteersStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Neurodawn Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Yongjun Wang, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935682
- Sponsor's protocol ID
- Y-4-LC-01
- Status last verified
- Apr 2025
- First submitted
- 2 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase 1 Study to Assess the Safety and Pharmacokinetics of Y-4 Tablets After Single- and Multiple-dose in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06935682
- Acronym / sponsor ID
- Y-4-LC-01
- Conditions
- Healthy Adult Male and Female Volunteers
- Keywords
- phase I trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Neurodawn Pharmaceutical Co., Ltd.
- Study start
- 4 Jan 2025 (actual)
- Primary completion
- 4 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 20 Apr 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.
Y-4 is a new fixed-dose combination drug product containing two active ingredients of pregabalin and riluzole.
The primary objective is to evaluate the safety and tolerability of Y-4 tablets in Chinese healthy adult subjects after single- and multiple-dose.
The secondary objective is to characterize the pharmacokinetics (PK) of pregabalin and riluzole in Chinese healthy adult subjects after single- and multiple-dose of Y-4 tablets.
Detailed description
This study will be a single-center, randomized, double-blind, placebo-controlled, dose-escalation study in Chinese healthy adult subjects. A total of 36 subjects, 3 cohorts of 12 subjects each (half men and half women), will be enrolled in this study. In each dose cohort, subjects will undergo single and multiple (BID, 11 doses) administration, among them, 10 subjects (half men and half women) will receive Y-4 tablets and 2 subjects (half men and half women) will receive placebo randomly.
After providing written informed consent, subjects will undergo screening for eligibility. Screening for the study will begin 14 days prior to the dosing. Subjects will be admitted to research center in the afternoon of Day-1 prior to the dosing day and fasting for the next 10 hours overnight. In the morning of the following day (Day 1), subjects will be administered the assigned dose of Y-4 tablets or placebo orally, then subjects will be monitored for the following 72 hours. During Day 5 to Day 9, the subjects will be required to be administered twice a day (Q12 h), once in the morning and once in the evening. In the morning of Day 10, subjects will be administered to the last dose. In the morning of Day 13 (approximately 72 hours after the last administration), the safety and tolerance will be evaluated and then subjects will be discharged.
A telephone follow-up/completion visit will be conducted 7 days (±1) post discharge.
Treatment cohorts are planned as following:
Cohort 1: 75 mg/18.75 mg Y-4 tablets (75 mg pregabalin and 18.75 mg riluzole) or placebo tablets (two little Y-4 tablets) Cohort 2: 112.5 mg/28.125 mg Y-4 tablets (112.5 mg pregabalin and 28.125 mg riluzole) or placebo tablets (one large Y-4 tablet) Cohort 3: 150 mg/37.5 mg Y-4 tablets (150 mg pregabalin and 37.5 mg riluzole) or placebo tablets (one large Y-4 tablet and one little Y-4 tablet)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Y-4 tables | Experimental | Drug: Y-4 tablesEach subject will receive a single dose and multiple doses. |
| Y-4 placebos | Placebo comparator | Drug: Y-4 placebosEach subject will receive a single dose and multiple doses. |
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 subjects, 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 subject, according to the calculation result × 0.85）.
- Subjects who are able to understand and give their signed informed consent before any trial related procedures are performed.
Key exclusion criteria (24 listed)
- Subjects 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 and Opadry amb Ⅱ), have allergic diseases or allergic constitution;
- Subjects who have special requirements for diet and cannot follow the unified diet;
- Physical examinations, vital signs, 12-lead electrocardiograms (ECG), chest X-ray (front position), laboratory tests (hematology, serum chemistry, coagulation test, urinalysis, etc.) and other screening tests found abnormalities that the researchers judged to be of clinical significance;
- Subjects 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 tablesEach subject will receive a single dose and multiple doses. During the single dose phase (Day1-Day4), the subjects will be administered with single dose of Y-4 tablets on fasting state in the morning of Day D1. During the multiple dosing phase (Day5-Day13), the subjects will be required to administer with Y-4 tablets continuously for 6 days, BID of Day5-Day9 (once in the morning and once in the evening, Q12h) and QD of Day10, for a total of 11 doses. | Drug | Y-4 tables |
| Y-4 placebosEach subject will receive a single dose and multiple doses. During the single dose phase (Day1-Day4), the subjects will be administered with single dose of Y-4 placebos on fasting state in the morning of Day D1. During the multiple dosing phase (Day5-Day13), the subjects will be required to administer with Y-4 placebos continuously for 6 days, BID of Day5-Day9 (once in the morning and once in the evening, Q12h) and QD of Day10, for a total of 11 doses. | Drug | Y-4 placebos |
Primary outcome
adverse events
Time frame: From the first day to the 19th± 1st day after the start of administration
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.
Incidence of subject getting abnormal results of laboratory tests after treatment
Time frame: From the first day to the 19th± 1st day after the start of administration
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.
Incidence of subject getting abnormal results of 12-lead ECG after treatment
Time frame: From the first day to the 19th± 1st day after the start of administration
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.
Incidence of subject getting abnormal results of vital signs after treatment.
Time frame: From the first day to the 19th± 1st day after the start of administration
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Vital signs(body temperature, respiration, blood pressure, and pulse) will be assessed by according equipment.(electronic sphygmomanometer, thermometer).
Incidence of subject getting abnormal results of physical examinations after treatment.
Time frame: From the first day to the 19th± 1st day after the start of administration
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Physical examinations will be conduct by the investigator through observation.
Incidence of subject getting abnormal results of blood oxygen saturation after treatment
Time frame: From the first day to the 19th± 1st day after the start of administration
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
Incidence of subject getting abnormal results of C-SSSRS scale evaluation after treatment after treatment
Time frame: From the first day to the 19th± 1st day after the start of administration
Record changes of C-SSSRS scale evaluation from baseline to post-treatment
22 secondary outcomes
Cmax
Time frame: From day 1 to day 4 after the start of administration
AUC0-t
Time frame: From day 1 to day 4 after the start of administration
AUC0-∞
Time frame: From day 1 to day 4 after the start of administration
Tmax
Time frame: From day 1 to day 4 after the start of administration
t1/2
Time frame: From day 1 to day 4 after the start of administration
λz
Time frame: From day 1 to day 4 and from day 8 to day 13 after the start of administration
AUC_%Extrap
Time frame: From day 1 to day 4 and from day 8 to day 13 after the start of administration
CL/F
Time frame: From day 1 to day 4 after the start of administration
Vz/F
Time frame: From day 1 to day 4 after the start of administration
MRT0-t
Time frame: From day 1 to day 4 after the start of administration
MRT0-∞
Time frame: From day 1 to day 4 after the start of administration
Cav, ss
Time frame: From day 8 to day 13 after the start of administration
Cmax, ss
Time frame: From day 8 to day 13 after the start of administration
Cmin, ss
Time frame: From day 8 to day 13 after the start of administration
AUCτ
Time frame: From 8 to day 13 after the start of administration
AUC0-t, ss
Time frame: From day 8 to day 13 after the start of administration
AUC0-∞, ss
Time frame: From day 8 to day 13 after the start of administration
Tmax, ss
Time frame: From day 8 to day 13 after the start of administration
t1/2, ss
Time frame: From day 8 to day 13 after the start of administration
CLss/F
Time frame: From day 8 to day 13 after the start of administration
Vz, ss/F
Time frame: From day 8 to day 13 after the start of administration
DF
Time frame: From day 8 to day 13 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 20 Apr 2025.
- Individual participant dataSharing planned: No
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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.
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 tables in people with Healthy Adult Male and Female Volunteers, run by Beijing Tiantan Hospital at 1 site in China.
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: looking for participants now, as of the sponsor's last update on 20 Apr 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 China. 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?
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 Ya Shu Li, Doctor (+010-59978555, shuyali85@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events (time frame: From the first day to the 19th± 1st day after the start of administration). The study lists 7 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 20 Apr 2025.