Clinical trials

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Status: Not yet recruiting

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.

Participants needed: 11
Trial details
Phase: Phase 1Age: 18-45Biological sex: AllType: InterventionalSponsor: Neurodawn Pharmaceutical Co., Ltd.Updated: Jun 1, 2026Locations: 1
Eligibility criteria

Healthy adult male and female participants, 18-45 years of age (including both e... [+3]

Participants who are known to be allergic to pregabalin, riluzole or any excipie... [+23]

Status: Recruiting

Y-4 to Treat the Postherpetic Neuralgia

The goal of this clinical trial is to assess the efficacy and safety of Y-4 in patients with postherpetic neuralgia(PHN). The main questions it aims to answer are: The efficacy and safety of Y-4 to treat PHN compared with pregabalin. Researchers will analyze data from different groups, includes Y-4 group and pregabalin group , to see efficacy of Y-4 and If drug Y-4 is safe and tolerate in the patients with PHN. Participants will : * Take Y-4 (1w titration period: 75 mg pregabalin +18.75 mg riluzole, 12w fixed dose period: 150 mg pregabalin +37.5 mg riluzole, 1w drug withdraw period: 1w titration period: 75 mg pregabalin +18.75 mg riluzole) or pregabalin(75 mg for 1w titration period , 150 mg for 12w fixed dose period ,75 mg for 1w drug withdraw period) twice a day for 14 weeks after run-in period (placebo) lasting for 1 week. * Visit the hospital according to the follow-up schedule agreed upon with your doctor. contact the research staff as soon as possible to reschedule when unable to attend the scheduled study visit. * Use investigational products as directed by the doctor and undergo the related treatment. * Inform their investigators of any changes in their health, including any side effects or symptoms, whether or not they believe these changes are related to the trial medication, as well as any new medications they are using or wish to use, or any changes in the dosage of medications they have already taking. * Use reliable contraceptive methods , such as abstinence, intrauterine devices, double barrier methods (e.g., condom with spermicide or condom with a diaphragm containing spermicide), contraceptive implants, or oral contraceptives (except if the partner is infertile) during the study period and within one month after the study is completed. * Must inform investigators immediately if they or their partner become pregnant during the study. * Be sure to inform other doctors being consultant that you are participating in this clinical study. * Restrict medication use and treatment during the study.

Participants needed: 160
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Neurodawn Pharmaceutical Co., Ltd.Updated: May 13, 2026Locations: 1
Eligibility criteria

1. Known previous allergy to the investigational products, rescue medication ing... [+7]

Status: Not yet recruiting

RK-4 Intracalvariosseous Injection in Treatment of Acute Large Hemispheric Infarction

An open-label, blinded Ib/IIa study investigating the treatment of acute large hemispheric infarction by transcranial bone marrow injection of RK-4 injection For subjects with acute large hemispheric infarction who are contraindicated to vascular recanalization or have poor response to vascular recanalization therapy, the safety, tolerability, and PK characteristics of RK-4 injection injected into the brain cell marrow through the cranial bone marrow will be preliminarily evaluated, and the efficacy will be preliminarily explored. The main questions it aims to answer are: * If drug RK-4 is safe and tolerate in the patients with LHI? * What the pharmacokinetic profiles of RK-4 injection injected into the brain cell marrow through the cranial bone marrow? * The efficacy of RK-4 injection injected into the brain cell marrow through the cranial bone marrow Researchers will analyze data from different groups, includes low dose group (1mg,QD), medium dose group(2mg,QD), high dose group(4mg,QD), to see If drug RK-4 is safe and tolerate in the patients with LHI and the pharmacokinetic profiles and efficacy of RK-4 injection injected into the brain cell marrow through the cranial bone marrow. Participants will: * Take drug RK-4 (1 mg or 2 mg or 4 mg) by transcranial bone marrow injection once daily for consecutive 3 days. * Truthfully provide medical history and "previous participation in clinical trials" and a statement of no history of mental disorders. * Take the drug at the specified time every day according to the dosage prescribed by the doctor * Receive the investigational drug as instructed by the doctor and visiting as required * Tell the investigators about any medications (including chemicals, biological drugs, proprietary Chinese medicines, etc.) and related treatments you take during the study * unpermitted stop the investigational drug yourself at the end of the study or when you decide to withdraw from the study, you need to stop the investigational drug as directed by your doctor to ensure your safety * take reasonable contraception actions * unallowed to use unmarketed drugs or other clinical trial drugs during the study

Participants needed: 18
Trial details
Phase: Phase 1, Phase 2Age: 18-80Biological sex: AllType: InterventionalSponsor: Neurodawn Pharmaceutical Co., Ltd.Updated: Sep 30, 2025Locations: 1
Eligibility criteria

18≤ age < 81 years old, gender is not limited; [+7]

Combined with acute cerebral hemorrhage and subarachnoid hemorrhage; [+22]

Status: Not yet recruiting

Y-3 for Injection in Patients With Hepatic Insufficiency and Healthy Subjects

The goal of this clinical trial is to assess the pharmacokinetic profiles and safety of Y-3 in subjects with mild hepatic insufficiency (Child-Pugh: grade A), moderate hepatic insufficiency (Child-Pugh: grade B) and gender, age, and weight matching normal hepatic function, so as to provide a scientific basis for rational clinical medication in patients with hepatic insufficiency. The main questions it aims to answer are: What the pharmacokinetic profiles of Y-3 (40 mg ) in subjects with mild hepatic insufficiency (Child-Pugh: grade A), moderate hepatic insufficiency (Child-Pugh: grade B) and gender, age, and weight matching normal hepatic function? If drug Y-3 (40mg ) is safe and tolerate in subjects with mild hepatic insufficiency (Child-Pugh: grade A), moderate hepatic insufficiency (Child-Pugh: grade B) and gender, age, and weight matching normal hepatic function. Investigators will compare pharmacokinetic safety profiles of Y-3 (40 mg ) in subjects with different hepatic functions( mild hepatic insufficiency, moderate hepatic insufficiency, normal. Participants will: Take drug Y-3 (40 mg) only once. Answer questions regarding your medical history. Comply with the study procedures and requests. Complete all tests and collections of PK Sampling. Fasting for more than 10 hours before administration, water abstinence for 1 h before and after administration, and eating standard lunch and dinner 4 hours and 10 hours after starting administration. Must not use of nicotine-containing products (including nicotine patches). Must not do strenuous exercise for 1 hour before each clinical laboratory test blood draw. Subjects may engage in light recreational activities for the duration of the study. Follow your doctor's instructions, answer the investigator's questions about your health status truthfully, and cooperate with the test-related tests. During the experiment, the test should be completed in strict accordance with the requirements of the investigator, and the test-related work such as drug administration and sample collection should be conscientiously cooperated, and the research center should not leave the research center without authorization, and the rules and regulations of the research center and the investigator 's propaganda and education should be observed. Any medication taken should be reported truthfully. Must come to the hospital at the agreed follow-up time with the investigator and you. Inform the investigator or relevant person about any changes in your health status, including any favorable or unfavorable changes. Must not participate in any other drug clinical trials during this trial. Must tell your investigator about all medical treatments you plan to receive during the study, such as elective surgery or radiation therapy. In addition to yourself, at least one member of your family is expected to be aware of the clinical research you will be involved in and care about your health, and will be able to provide feedback to your doctor about your health during follow-up visits. Your family should promptly notify your study physician if you become seriously unwell, including hospitalization for treatment. Notify your investigator if your address, phone number, or other contact information changes. Must not use medications that may interfere with PK or safety.

Participants needed: 24
Trial details
Phase: Phase 1Age: 18-70Biological sex: AllType: InterventionalSponsor: Neurodawn Pharmaceutical Co., Ltd.Updated: Jul 8, 2025
Eligibility criteria

The subject fully understands the purpose and requirements of this trial, volunt... [+9]

Irritable the physique, such as those with a known history of allergy to two or... [+27]