Clinical trial NCT06206824: Leucettinib-21 First-in-Human Phase 1 in Healthy Volunteers and Subjects With Down Syndrome and Alzheimer's Disease
Official title: 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
Conditions: Healthy Volunteers
Down Syndrome
Alzheimer's Disease
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.
Interventions:
description: See arm's description.
name: Leucettinib-21
type: Drug
Study arms:
design_group_description: A total of 48 healthy male volunteers will be randomized into six consecutive single ascending dose cohorts of 8 subjects, 6 receiving one dose of Leucettinib-21 and 2 receiving placebo.
design_group_title: Part 1 : Single Ascending Doses in Healthy Volunteers
design_group_type: Experimental
design_group_description: A total of 12 healthy male volunteers will be randomly assigned to one of two sequences in this cross over study part. All subjects will receive the same one dose of Leucettinib-21 in each sequence.
design_group_title: Part 2 : Food-Effect in Healthy Volunteers
design_group_type: Experimental
design_group_description: A total of 36 healthy male volunteers will be randomized into three consecutive multiple ascending doses cohorts of 12 subjects, 9 receiving one dose of Leucettinib-21 and 3 receiving placebo everyday for 14 days.
design_group_title: Part 3 : Multiple Ascending Doses over 14 days in Healthy Volunteers
design_group_type: Experimental
design_group_description: A total of 12 people with Down Syndrome and 12 people with Alzheimer's Disease will receive the same one dose of Leucettinib-21.
design_group_title: Part 4 : Single Dose in People with Down Syndrome and Alzheimer's Disease
design_group_type: Experimental
design_group_description: A total of 32 healthy volunteers will be randomized into three consecutive single ascending dose cohorts, of 16 male and female subjects for the first cohort, 12 receiving one dose of Leucettinib-21 and 4 receiving placebo, and 8 male subjects for the two following cohorts, 6 receiving one dose of Leucettinib-21 and 2 receiving placebo.
design_group_title: Part 5 : Single Ascending Doses in Healthy Volunteers
design_group_type: Experimental
design_group_description: A total of 12 healthy male volunteers will be randomized into one cohort of 12 subjects, 9 receiving one dose of Leucettinib-21 and 3 receiving placebo everyday for 14 days.
design_group_title: Part 6 : Single dose over 14 days in Healthy Volunteers
design_group_type: Experimental
Sponsor: Perha Pharmaceuticals
Collaborators: European Research Council
Fondation Jérôme Lejeune
Drug name mappings:
name: Leucettinib-21
lang: EN