Y-3 for Safety Evaluation

Overseen By Mohammed

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Neurodawn Pharmaceutical Co., Ltd.

Must not be taking: Traditional medicines, Herbal medicines

Disqualifiers: Cardiovascular, Endocrine, CNS, others

Compensation: Varies

Number of Visits: 5

Duration: 4 days

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

Yes, you must stop taking any other medications, including traditional Chinese medicines and herbal medicines, during your time in the study.

What safety data exists for the treatment Y-3?

The research articles provided do not contain specific safety data for the treatment Y-3. They discuss general approaches to safety evaluation and reporting in clinical trials, but no specific information about Y-3's safety profile is mentioned. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

Healthy adults in the US, aged 18-45 with a BMI of 19-28 kg/m2 can join this trial. They must be free from medical conditions as confirmed by tests and willing to stay at the research facility for 4 nights. Participants should not have special diets, consume lots of caffeine or foods like grapefruit, papaya, mango; take other medicines or herbal supplements; engage in sexual activity without contraception; become pregnant; get vaccinated; donate blood elsewhere; drink alcohol or smoke during the study.

Inclusion Criteria

Fully understand and provide a signed informed consent before performing any study-related procedures

Comply with the study and follow-up procedures

I weigh at least 50 kg if male, 45 kg if female, and my BMI is between 19-28.

Exclusion Criteria

Known allergy to Y-3 or any of its excipients

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Baseline

Participants undergo baseline assessments before treatment

1 day

Treatment

Participants receive a single dose of Y-3 (40 mg or 60 mg) or placebo and are monitored for pharmacokinetic profiles

4 days

4-night stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Y-3

Trial Overview The trial is testing Y-3 injection at doses of 40 mg and 60 mg against a placebo to see how it's processed by the body (pharmacokinetics) and if it's safe and well-tolerated. Volunteers will receive one dose of either Y-3 or placebo once only, followed by monitoring their health status and collecting samples to analyze how Y-3 behaves inside the body.

How Is the Trial Designed?

Group I: Y-3 for injection (Y-3) Experimental Treatment 1 Intervention

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.

Group II: placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Neurodawn Pharmaceutical Co., Ltd.

Lead Sponsor

Trials

7

Recruited

3,500+

Published Research Related to This Trial

The PROSPER Consortium aims to enhance safety reporting in healthcare by integrating patient-reported outcomes (PROs) into the assessment of adverse events, recognizing the importance of the patient's perspective in understanding treatment effects.

Despite advancements in technology and increased focus on patient involvement, current safety reporting still heavily relies on healthcare professionals, which can lead to under-reporting and discrepancies between patient experiences and clinician perceptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance. Banerjee, AK., Okun, S., Edwards, IR., et al.[2022]

The study highlights the inefficiency of manual management of serious adverse events (AEs) and reactions (ARs) in clinical trials, emphasizing the need for improved reporting systems.

A new data model has been developed to facilitate automatic code generation for a software tool designed to assist in the management of AE/AR data, potentially enhancing the efficiency and effectiveness of regulatory compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling an IT Support for Handling Serious Adverse Events in Clinical Trials. Fonck, S., Deserno, T.[2018]

The electronic safety reporting (ESR) module significantly improved the efficiency and consistency of reporting serious adverse events in a large multicenter clinical trial, processing 397 reports and submitting 33 FDA MedWatch reports.

By integrating safety and efficacy data within the same database, the ESR module streamlined the reporting process, reducing redundant data entry and enhancing the overall management of clinical trial data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A web-based medical safety reporting system for a large multicenter clinical trial: the ALIAS experience. Zhao, W., Waldman, BD., Dillon, C., et al.[2021]

The Safety Evaluation Plan (SEP) is a crucial tool for systematically assessing and managing human safety risks throughout the life cycle of pharmaceutical products, integrating data from various sources to ensure comprehensive safety analysis.

Adopting a problem-oriented approach in safety evaluations allows for early identification of safety issues and proactive risk management, which aligns with regulatory expectations and enhances communication within pharmaceutical companies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A problem-oriented approach to safety issues in drug development and beyond. Haas, JF.[2018]

In the ICON8 ovarian cancer clinical trial, 51,019 adverse events were reported, but only 61% of serious adverse events were matched to existing adverse events, indicating a significant gap in safety reporting.

Re-analyzing safety data by including serious adverse events increased the detection of grade 3 or worse safety events, highlighting the importance of comprehensive safety data collection for accurate risk assessment in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overlap between adverse events (AEs) and serious adverse events (SAEs): a case study of a phase III cancer clinical trial. James, EC., Dunn, D., Cook, AD., et al.[2021]

Citations

1. New Zealand pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Modeling an IT Support for Handling Serious Adverse Events in Clinical Trials. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

A web-based medical safety reporting system for a large multicenter clinical trial: the ALIAS experience. [2021]

4. New Zealand pubmed.ncbi.nlm.nih.gov

A problem-oriented approach to safety issues in drug development and beyond. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Overlap between adverse events (AEs) and serious adverse events (SAEs): a case study of a phase III cancer clinical trial. [2021]