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A Study to Assess Single and Multiple Doses of IkT-148009 in Healthy Elderly Participants and Parkinson's Patients

NCT04350177 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2025-03-10

No results posted yet for this study

Summary

This study investigates the safety and tolerability of drug IkT-148009 in healthy elderly volunteers (55 to 70 years old). This first-in-human study is designed in 3 parts. In Part A, healthy participants will take a single, oral dose of IkT-148009 or placebo. Part A participants will be at the study site for approximately 4 days. In Part B, healthy participants will take an oral dose of IkT-148009 once a day for 7 days. Part B participants will be at the study site for approximately 12 days. In Part C, Parkinson\'s patients will take an oral dose of IkT-148009 once a day for 7 days. Part C participants will be at the study site for approximately 12 days.

Conditions

  • Healthy Elderly
  • Parkinson Disease

Interventions

DRUG

IkT-148009

Oral administration gelatin capsule

DRUG

Placebo

Oral administration gelatin capsule

Sponsors & Collaborators

  • ABLi Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Howard Hassman, MD · Hassman Research Institute

  • Larry Blob, MD · Cognitive Research Corporation

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
55 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-16
Primary Completion
2022-10-30
Completion
2023-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04350177 on ClinicalTrials.gov