What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease include levodopa, dopamine agonists, and MAO B inhibitors. Levodopa, often combined with carbidopa, can cause nausea, somnolence, dizziness, headache, confusion, hallucinations, delusions, agitation, psychosis, and orthostatic hypotension. Dopamine agonists, such as pramipexole and ropinirole, may lead to side effects like edema, somnolence, constipation, dizziness, hallucinations, and nausea. MAO B inhibitors, like selegiline and rasagiline, generally have fewer side effects but can include insomnia, nausea, and headache. These side effects are important considerations in the management of PD.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Parkinson's Disease, focusing on managing motor symptoms and improving quality of life. Key treatments include VMAT2 inhibitors like tetrabenazine, deutetrabenazine, and valbenazine, which help manage chorea and tardive dyskinesia. Dopamine agonists such as pramipexole, ropinirole, and rotigotine are also widely used, either as monotherapy or in combination with levodopa, to reduce motor symptoms. MAO B inhibitors like selegiline and rasagiline offer a once-daily option to augment the effects of levodopa. Additionally, amantadine is used for patients with significant tremor. These treatments aim to balance dopaminergic activity in the brain, similar to the potential mechanism of action for HNC364.

What other types of research exist?

Promising novel alternatives to HNC364 for Parkinson's Disease treatment in 2024 include IRC-082451, which reduces L-DOPA-induced dyskinesias and inhibits neuronal excitotoxicity and oxidative stress; LY503430, which offers neuroprotection and has good oral bioavailability; Neuropeptide S (NPS), which counteracts motor deficits by facilitating dopaminergic neurotransmission; and Nilotinib, which improves motor behavior and degrades α-synuclein via autophagic pathways.

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HNC364 for Parkinson's Disease

Phase 1

Waitlist Available

Led By Frank Lee, MD

Research Sponsored by Guangzhou Henovcom Bioscience Co. Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to 80 days post dose

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called HNC364 in humans for the first time. It aims to see if the drug is safe and well-tolerated by studying how it behaves in the body.

Who is the study for?

This trial is for adults with Parkinson's Disease who haven't used nicotine products, alcohol, or certain medications recently. They must not have HIV, hepatitis B/C, a history of drug abuse or severe allergies, and women cannot be pregnant. Participants should not have other health conditions that could interfere with the study.

What is being tested?

The trial tests HNC364 injectable suspension to see if it's safe and how it affects people with Parkinson's Disease. It involves giving increasing doses once through a muscle shot and watching what happens (safety/tolerability) and how the body processes it (PK/PD).

What are the potential side effects?

Since this is a first-in-human study for HNC364, specific side effects are unknown but may include typical injection reactions like pain at the site, swelling, redness; also general symptoms such as headache, nausea or fatigue might occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to 80 days post dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to 80 days post dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to 80 days post dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic procedure

Secondary study objectives

AUC extrapolated to infinity (AUC0-inf)

Apparent total clearance for extravascular administration (CL/F)

Apparent volume of distribution during terminal phase (Vz/F)

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: 80 mg HNC364Experimental Treatment1 Intervention

8 subjects will be admitted to the clinical study center on Day -1 and receive a single intramuscular dose of 80 mg HNC364 on Day 1, and undergo timed safety, PK, and PD assessments for 60days post dose.

Group II: 60 mg HNC364Experimental Treatment1 Intervention

8 subjects will be admitted to the clinical study center on Day -1 and receive a single intramuscular dose of 60 mg HNC364 on Day 1, and undergo timed safety, PK, and PD assessments for 60 days post dose.

Group III: 40 mg HNC364Experimental Treatment1 Intervention

8 subjects will be admitted to the clinical study center on Day -1 and receive a single intramuscular dose of 40 mg HNC364 on Day 1, and undergo timed safety, PK, and PD assessments for 29 days post dose.

Group IV: 20 mg HNC364Experimental Treatment1 Intervention

pre-study will recruit 2 subjects (both male and female) to receive 20 mg HNC364 intramuscular administration to evaluate the safety and tolerability of HNC364 injectable suspension. Then 8 subjects will be admitted to the clinical study center on Day -1 and receive a single intramuscular dose of 20 mg HNC364 on Day 1, and undergo timed safety, PK, and PD assessments for 80 days post dose.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HNC364

2022

Completed Phase 1

~40

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Parkinson's Disease (PD) primarily aim to increase or mimic dopamine, a neurotransmitter that is deficient in PD. Levodopa, often combined with carbidopa, is converted to dopamine in the brain, directly replenishing dopamine levels. Dopamine agonists (e.g., pramipexole, ropinirole) stimulate dopamine receptors, mimicking dopamine's effects. MAO B inhibitors (e.g., rasagiline, selegiline) prevent the breakdown of brain dopamine, prolonging its action. Amantadine promotes dopamine release and has anticholinergic effects. These treatments are crucial as they help manage motor symptoms, improving the quality of life for PD patients.

Thalamic noradrenaline in Parkinson's disease: deficits suggest role in motor and non-motor symptoms.