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?

This trial tests a new drug, Y-3, to determine its safety and how the body processes it. Healthy adults in the U.S. will receive either a low or high dose of Y-3 or a placebo, which is a harmless look-alike. The goal is to assess whether participants can tolerate the drug without issues. Ideal candidates for this trial are healthy individuals who do not smoke or drink heavily and have no special dietary needs. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

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.

Is there any evidence suggesting that Y-3 is likely to be safe for humans?

Research shows limited information about the safety of Y-3 for humans. This trial, in its early stages, primarily focuses on understanding the safety of Y-3 and how the body processes it. As a result, little is known about its tolerability or potential side effects.

In this study, Y-3 will be tested at two doses, 40 mg and 60 mg, to determine if healthy adults can take it without issues. Participants will take the drug only once, and researchers will closely monitor for any negative reactions. Since this trial is early in the research process, safety data is still being collected.

If Y-3 were already approved for other uses, it might suggest some level of safety, but that is not the case here. This trial is an important step in understanding how safe Y-3 is for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Y-3 because it offers a novel approach compared to current treatments for its target condition. While most standard treatments rely on established mechanisms, Y-3 introduces a new active ingredient with a unique formulation that involves a lyophilized powder and a concentrated solution. This innovative delivery method, involving intravenous infusion, may enhance the drug's stability and effectiveness. The potential for Y-3 to work through a different pathway and its distinct administration process make it a promising new option that could address limitations of existing therapies.

What evidence suggests that Y-3 might be a safe and tolerable treatment?

Research has shown that Y-3 is under study for its potential to treat certain health issues. The current trial evaluates the safety and effectiveness of Y-3, with participants receiving either Y-3 or a placebo. Earlier trials indicated that Y-3 showed promise, especially when administered soon after specific medical events. However, limited information exists on its effectiveness for new conditions, as current studies primarily focus on safety and dosage. Y-3 may help manage certain health problems by interacting with specific parts of the body. Early results regarding its safety are positive, but further research is needed to understand its efficacy. ^{1 2 6 7 8}

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

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-1-pharmacokinetic-study-in-healthy-volunteers-2025-81bff

Y-3 for Safety Evaluation 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.

2. svn.bmj.com svn.bmj.com/content/early/2025/06/02/svn-2024-004011

Efficacy and safety of Y-3 intracalvariosseous injection ... The SOLUTION-2 trial will investigate the safety and efficacy of Y-3 ICO injection initiated within 24 hours in the treatment of LHI.

3. ema.europa.eu ema.europa.eu/en/documents/scientific-guideline/ich-e-3-structure-and-content-clinical-study-reports-step-5_en.pdf

E 3 Structure and Content of Clinical Study Reports DISCUSSION AND OVERALL CONCLUSIONS. The efficacy and safety results of the study and the relationship of risks and benefit should be briefly summarised and ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07226362

NCT07226362 | A Study Evaluating the Safety, Tolerability ... A phase of research to describe clinical trials that gather more information about a drug's safety and effectiveness by studying different ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9378423/

Reporting of clinical trial safety results in ClinicalTrials.gov ... Structured results data in ClinicalTrials.gov may represent a novel source of information on adverse events that could be leveraged in the post-marketing phase.

6. mayoclinic.org mayoclinic.org/diseases-conditions/prescription-drug-abuse/in-depth/kratom/art-20402171

Kratom: Unsafe and ineffective Side effects and safety concerns · Weight loss. · Dry mouth. · Nausea and vomiting. · Constipation. · Liver damage. · Muscle pain. · High blood ...

7. nrc.gov nrc.gov/docs/ML0515/ML051580319.pdf

safety evaluation for the aging management of steam generators ... The staff of the Steam Generator Integrity and Chemical Engineering Section of the Materials and Chemical Engineering Branch has completed its review of the ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31913519/

Long-Term Safety Evaluation of Ubrogepant for the Acute ... Long-term intermittent use of ubrogepant 50 and 100 mg given as 1 or 2 doses per attack for the acute treatment of migraine was safe and well tolerated.