20 mg HNC364 for Parkinson's Disease (PD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Frontage Clinical Services, Inc., Secaucus, NJ
Parkinson's Disease (PD)+1 More
HNC364 - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

This is a non-randomized, dose-escalation first-in-human study to evaluate the safety, tolerability, PK, and PD of HNC364 following intramuscular administration of single ascending doses.

Eligible Conditions

  • Parkinson's Disease (PD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Parkinson's Disease (PD)

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Day 1 to 80 days post dose

Day 80
AUC extrapolated to infinity (AUC0-inf)
Apparent total clearance for extravascular administration (CL/F)
Apparent volume of distribution during terminal phase (Vz/F)
Area under the concentration-time curve (AUC) from time 0 to the last measurable concentration (AUC0-last)
Elimination rate constant (Kel)
Maximum observed concentration (Cmax)
Mean residence time (MRT)
Number of Participants With Treatment Emergent Adverse Events
Platelet MAO-B activity
Time at which half the drug has been eliminated (t½)
Time to maximum concentration (Tmax)

Trial Safety

Safety Progress

1 of 3

Other trials for Parkinson's Disease (PD)

Trial Design

2 Treatment Groups

20 mg HNC364
1 of 2
40 mg HNC364
1 of 2
Experimental Treatment

18 Total Participants · 2 Treatment Groups

Primary Treatment: 20 mg HNC364 · No Placebo Group · Phase 1

20 mg HNC364
Drug
Experimental Group · 1 Intervention: HNC364 · Intervention Types: Drug
40 mg HNC364
Drug
Experimental Group · 1 Intervention: HNC364 · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 to 80 days post dose
Closest Location: Frontage Clinical Services, Inc. · Secaucus, NJ
2018First Recorded Clinical Trial
1 TrialsResearching Parkinson's Disease (PD)
6 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Those who had a history of drug abuse or used drugs within 2 years before screening or those who were positive for urinary drug screening during the screening period.
Subjects who had a history of smoking or used other nicotine-containing products within 3 months before the study drug administration, or who were positive for urine nicotine test during screening.
You have positive blood tests for HIV, hepatitis B, or hepatitis C.
You have a history of severe allergy or allergy to the study drug and any of its components or related excipients.
Subjects must be at least 18 years of age and have a history of clinically significant disease as determined by the Investigator.
You have a history of gastrointestinal, liver and kidney diseases or surgery that potentially affect the absorption, distribution, metabolism and excretion of the study drug.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.