HNC364 for Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new long-acting injection called HNC364 Injectable Suspension, comparing it to the existing Parkinson's disease medication, rasagiline tablets. Researchers aim to determine the safety and absorption of the injected form. The trial seeks healthy adults who do not smoke and have no serious medical conditions. Participants will receive the injection once every four weeks and will undergo safety monitoring. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Do I have to stop taking my current medications for the trial?
Yes, you will need to stop taking any prescription or over-the-counter drugs, vitamins, or herbal medicines at least 2 weeks before starting the trial medication.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that HNC364, a new injectable treatment for Parkinson’s disease, remains in the early testing stages. Researchers are carefully studying it to ensure human safety. So far, studies have focused on the body's reaction to the drug and its overall safety.
Detailed safety information is limited at this stage. However, as this is the first phase of the study, researchers primarily assess the drug's safety for humans. This phase involves identifying side effects and understanding how the drug functions in the body. While it's too early to fully determine its safety, this phase is a crucial first step. If HNC364 passes these tests without major issues, it can advance to more advanced research stages.12345Why do researchers think this study treatment might be promising for Parkinson's disease?
HNC364 Injectable Suspension is unique because it uses a new delivery method: a deep intramuscular injection into the deltoid muscle. Unlike most standard Parkinson's treatments that are taken orally, this injectable approach might enhance the delivery and effectiveness of the therapy over time. Researchers are excited about HNC364 because it could potentially offer a more controlled release of the medication, improving how well it works and possibly reducing side effects. Additionally, the treatment involves fewer doses, which could simplify the management of the condition for patients.
What evidence suggests that HNC364 might be an effective treatment for Parkinson's disease?
This trial will compare HNC364 Injectable Suspension with Rasagiline Tablets for treating Parkinson's disease. Research has shown that rasagiline effectively treats Parkinson's symptoms, particularly by improving movement. In earlier studies, rasagiline significantly reduced symptoms like tremors and stiffness. This drug blocks an enzyme called MAO-B, which breaks down dopamine, a brain chemical crucial for movement. By increasing dopamine levels, rasagiline improves movement-related symptoms in Parkinson's disease. Although HNC364 is new, it converts into rasagiline after injection, suggesting it may offer similar benefits based on rasagiline's mechanism.46789
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18-55, both men and women, with a BMI between 18 and 32. Participants must be nonsmokers, have normal or insignificant health findings, meet weight requirements (men ≥50 kg, women ≥45 kg), and agree to use effective birth control during the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive HNC364 injectable suspension or rasagiline tablets to evaluate relative bioavailability and assess safety and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- HNC364 Injectable Suspension
Trial Overview
The study compares how much of the drug gets into the body from HNC364 injectable suspension versus standard rasagiline tablets in healthy volunteers. It also checks safety after multiple injections of HNC364.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Subjects in HNC364 cohort will receive a deep IM injection of HNC364 injectable suspension in the deltoid muscle at a dose of 60 mg every 4 weeks for 4 repeated doses. Subjects will be allowed to leave the clinical site the next day after receiving each dose and return to clinical site on 7 days, 14 days and 28 days (before next administration) after each dose for safety and tolerability assessments. Besides, subjects will return to the clinical site on 4 days after the first dose and the last dose due to PK and PD blood sample collections.
Subjects in rasagiline tablets cohort will receive 1 mg of rasagiline tablets orally once daily for 20 days, followed by 2 mg once daily for 5 days. Subjects will remain domiciled at the clinic stay until Day 26 and have a follow-up visit on Day 29 due to PK and PD blood sample collections
Find a Clinic Near You
Who Is Running the Clinical Trial?
Guangzhou Henovcom Bioscience Co. Ltd.
Lead Sponsor
Frontage Clinical Services, Inc.
Collaborator
Citations
Relative Bioavailability Study of HNC364 Injectable ...
This is a non-randomized, open-label, Phase 1 study to evaluate the relative bioavailability of HNC364 injectable suspension relative to AZILECT® (rasagiline ...
2.
nebula.wsimg.com
nebula.wsimg.com/ab8afc773fcac385268961ac2d8759a1?AccessKeyId=6426D80A67BC65B05910&disposition=0&alloworigin=1Clinical Trials for Parkinson's Disease Drug Therapies
injectable MAO-B inhibitor. Phase 1. A Study to Evaluate the Safety, Tolerability, PK and PD of. HNC364 Injectable Suspension. 34. Recruiting.
Rasagiline in Parkinson's Disease - Clinical Trials ... - ICH GCP
Relative Bioavailability Study of HNC364 Injectable Suspension. Parkinson's Disease (PD). Merck Sharp & Dohme LLC. Completed. A Placebo- and Active Controlled ...
Azilect (rasagiline) — Teva | Drug Profile - Drug Landscape
Approximately half of patients in clinical trials were 65 years and over. There were no significant differences in the safety profile of the ...
Parkinson Disease, Late-Onset (PD)
Core motor features include bradykinesia, resting tremor, muscular rigidity, postural instability, gait problems with falls, and painful or dystonic cramps.
6.
ctv.veeva.com
ctv.veeva.com/study/a-study-to-evaluate-the-safety-tolerability-pk-and-pd-of-hnc364-injectable-suspensionA Study to Evaluate the Safety, Tolerability, PK and PD of ...
This is a non-randomized, dose-escalation first-in-human study to evaluate the safety, tolerability, PK, and PD of HNC364 following intramuscular administration ...
HNC364 - Drug Targets, Indications, Patents
... Injection in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HNC364 Injectable Suspension.
8.
trial.medpath.com
trial.medpath.com/organization/e1b1d2675f0b2607/guangzhou-henovcom-bioscience-co-ltdGuangzhou Henovcom Bioscience Co.,Ltd - MedPath
... Safety, Tolerability, PK and PD of HNC364 Injectable Suspension. Phase 1. Recruiting. Conditions. Parkinson's Disease. Interventions. Drug: HNC364. Subscribe.
Frontage Trials
NCT05523570: A Study to Evaluate the Safety, Tolerability, PK and PD of HNC364 Injectable Suspension. Completed. 1. 34. US. HNC364, HNC364 injectable suspension.
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