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HNC364 for Parkinson's Disease

Phase 1
Recruiting
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

Study Summary

This trial is testing a new drug to see if it is safe and how it is tolerated by humans. They will also study how the drug is absorbed and how it works 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.Check my eligibility
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).See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Secondary outcome measures
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

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.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Guangzhou Henovcom Bioscience Co. Ltd.Lead Sponsor
4 Previous Clinical Trials
187 Total Patients Enrolled
Frank Lee, MDPrincipal InvestigatorFrontage Clinical Services, Inc.
7 Previous Clinical Trials
463 Total Patients Enrolled

Media Library

HNC364 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05523570 — Phase 1
Parkinson's Disease Research Study Groups: 80 mg HNC364, 20 mg HNC364, 40 mg HNC364, 60 mg HNC364
Parkinson's Disease Clinical Trial 2023: HNC364 Highlights & Side Effects. Trial Name: NCT05523570 — Phase 1
HNC364 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05523570 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for this clinical trial greater than 45 years?

"The requirements for this research necessitate that potential participants are between 18 and 45 years old. There is a total of 27 trials available to those younger than 18 while 482 studies can be found by people over the age of 65."

Answered by AI

Do I qualify to be a participant in this research?

"This study is recruiting 18 individuals from ages 18 to 45 with a verified diagnosis of Parkinson's disease. Additionally, participants should not have any concurrent alcoholism (defined as consuming 14 units per week), prior drug abuse/intake in the past two years, nicotine use within 3 months before enrollment or screening positive for HIV, Hepatitis b & C; nor be using strong liver enzyme inhibitors and inducers such as ciprofloxacin, clopidogrel itraconazole etc., other medications including OTC drugs and vitamin supplements 2 weeks prior to enrollment; special diet items like pitaya mango grapefruit high ty"

Answered by AI

Is there a possibility to join the clinical trial at this juncture?

"Indeed, the records on clinicaltrials.gov demonstrate that this investigation is currently accepting enrollees. It was published online on August 22nd 2022 and subsequently revised on August 29th 2022. The trial seeks 18 participants at a single medical site."

Answered by AI

How many test subjects are enrolled in this clinical experiment?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial, which was originally posted on August 22nd 2022, is actively searching for participants. The study requires 18 patients to be recruited from 1 medical centre."

Answered by AI

Is HNC364 known to have any adverse effects on humans?

"The paucity of clinical data surrounding HNC364's effects on safety led to it receiving a score of 1."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What site did they apply to?
Frontage Clinical Services, Inc.
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I'd like to find a drug that will halt the progression on PD.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety, Tolerability, PK and PD of HNC364 Injectable Suspension
2022. "A Study to Evaluate the Safety, Tolerability, PK and PD of HNC364 Injectable Suspension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05523570.
~0 spots leftby Apr 2024
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