RecruitingPhase 1NCT06206824

Leucettinib-21 First-in-Human Phase 1 in Healthy Volunteers and Subjects With Down Syndrome and Alzheimer's Disease

Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate Safety, Tolerability, PK/PD of SAD, MAD and Food Effect of Leucettinib-21 in Healthy Male Subjects, and Single Dose in Subjects With Down Syndrome or Alzheimer's Disease

Sponsor

Perha Pharmaceuticals

Enrollment

164 participants

Start Date

Jan 18, 2024

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteers Down Syndrome

Summary

Leucettinib-21 First-in-Human Phase 1 Study in 6 Parts: Single (Part 1 and 5) and Multiple (Part 3 and 6) Ascending Doses, and Food-Effect (Part 2) in Healthy Subjects, and Single Dose (Part 4) in People with Down Syndrome (DS) and Alzheimer's Disease (AD). For Parts 1, 3, 4, 5 and 6, safety and tolerability of an oral administration of Leucettinib-21 will be assessed as primary objectives. Pharmacokinetics and pharmacodynamic biomarkers will be investigated as secondary objectives. For Part 2, the effect of high fat meal will be evaluated on the pharmacokinetics parameters after an oral administration of Leucettinib-21.

Eligibility

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called Leucettinib-21 in healthy volunteers and in people with Down syndrome who also have Alzheimer's disease. The drug targets a specific protein involved in brain cell death, and researchers want to see if it is safe and how the body processes it. **You may be eligible if...** - You are a healthy adult aged 18–55 (for early safety phases) - OR you have Down syndrome and Alzheimer's disease (for later phases) - You and/or your caregiver can give informed consent - You agree to use appropriate contraception during and after the study **You may NOT be eligible if...** - You have significant health conditions that could interfere with the drug - You are taking medications that interact with the study drug - You are pregnant or unwilling to follow contraception requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.