NCT06206824

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Perha Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers
• Down Syndrome
• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Leucettinib-21	See arm's description.

Timeline

• Start date: 2024-01-18
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-01-16
• Last updated: 2025-12-10

Locations

1 site across 1 country: France