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Single Ascending Dose (SAD) for Parkinson's Disease

Phase 1
Waitlist Available
Led By John E. Laabs, MD
Research Sponsored by Inhibikase Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part c only, up to 1 year
Awards & highlights

Study Summary

This trial is testing a new drug, IkT-148009, to see if it is safe and tolerated in healthy elderly volunteers, and also to see how it moves through the body. The trial is designed in 3 parts, with healthy volunteers in the first two parts and Parkinson's patients in the third part.

Eligible Conditions
  • Parkinson's Disease
  • Healthy Aging

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part c only, up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and part c only, up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetic AUC of IkT-148009
Pharmacokinetic AUC to last time point of IkT-148009
Pharmacokinetic Cmax of IkT-148009
+10 more
Other outcome measures
Change from Baseline to Final Visit in Complete Bowel Movement Score (CSBM).
Parkinson Disease
Change from Baseline to Final Visit in the MDS-UPDRS Non-motor aspects of experiences of daily living (Part I) Score and in the MDS- UPDRS Motor aspects of experiences of daily living (Part II) Score.
+7 more

Trial Design

3Treatment groups
Active Control
Group I: Single Ascending Dose (SAD)Active Control2 Interventions
In Part A, cohorts will consist of eight (8) subjects; six (6) of whom will receive treatment with IkT-148009 and two (2) with matching placebo.
Group II: Multiple Ascending Dose (MAD) Parkinson's patientsActive Control2 Interventions
In Part C, cohorts will consist of eight (8) patients; six (6) of whom will receive treatment with IkT-148009 and two (2) with matching placebo.
Group III: Multiple Ascending Dose (MAD)Active Control2 Interventions
In Part B, cohorts will consist of eight (8) subjects; six (6) of whom will receive treatment with IkT-148009 and two (2) with matching placebo.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Inhibikase Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
184 Total Patients Enrolled
John E. Laabs, MDPrincipal InvestigatorCelerion
Howard Hassman, MDPrincipal InvestigatorHassman Research Institute

Frequently Asked Questions

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

Are there numerous medical facilities across Canada that are conducting this experiment?

"This investigation is currently being conducted in 5 different medical facilities, including Hallandale Beach, Farmington Hills and Marlton. To minimize the effort of travel, participants should choose a facility that is closest to their home."

Answered by AI

Is there availability for participants to join the clinical trial?

"Clinicaltrials.gov indicates that the recruitment phase for this trial has been completed, as its last update was on June 30th 2022. While applications are not being accepted at this time, there exist 486 other clinical trials actively recruiting patients."

Answered by AI

Could I potentially partake in this experimental research?

"To be eligible to take part in this study, individuals must have been diagnosed with Parkinson's disease and fall between the age brackets of 55-70 years old. The trial is searching for approximately 101 contributors."

Answered by AI

Are senior citizens able to enroll in this clinical trial?

"This trial requires participants to be within the age range of 55 and 70 years. There are 28 trials for minors below 18, and 483 studies recruiting patients beyond 65."

Answered by AI

What risks have been associated with administering Multiple Ascending Dose treatments to Parkinson's patients?

"Given the early stage of this clinical trial, our team at Power judged that MAD Parkinson's patients would be safe to administer with a score of 1. This was due to limited data regarding efficacy and safety."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Collaborative Neuroscience Research, LLC
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Assess Single and Multiple Doses of IkT-148009 in Healthy Elderly Participants and Parkinson's Patients
2021. "A Study to Assess Single and Multiple Doses of IkT-148009 in Healthy Elderly Participants and Parkinson's Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04350177.
~24 spots leftby Apr 2025
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