NCT05170737

AEF0217 First-in-Human Phase I Study in 3 Parts (Single and Multiple Ascending Doses, and Food Effect) in Healthy Subjects.

A First-In-Human Phase I Study in 3 Parts: Randomized, Double-blind, Placebocontrolled, Sequential Group Investigation of the Safety, Tolerability, Pharmacokinetics of AEF0217 After Oral, Single and Multiple Ascending Doses, and an Open Label, Cross-over Investigation of the Effect of Food on the Bioavailability of AEF0217 in Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Aelis Farma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This trial is divided in 3 parts: FIH-SAD (Single Ascending Doses), FIH-MAD (Multiple Ascending Doses) and FIH-FE (Food effects). FIH-SAD will start first. The start of FIH-MAD will await the results of at least three cohorts from the FIHSAD study before initiated. The starting dose of the FIH-MAD will have been shown to be well tolerated and one dose level lower than the highest dose for which safety, tolerability and pharmacokinetic (PK) data are available. FIH-FE will be the last to start after the completion of FIH-SAD and conducted in parallel with parts of FIH-MAD.

Conditions

• Safety, Tolerability, Pharmacokinetics of AEF0217

Interventions

Type	Name	Description
DRUG	AEF0217	PART I: A total of 32 healthy male and female subjects will be randomized into four consecutive single ascending dose cohorts of 8 subjects. The study will have 4 different doses of AEF0217 (0.2, 0.6, 2 \& 6 mg) and 1 dose of matching placebo. A given subject can be randomized only in one dose level cohort. PART II: A total of 24 healthy subjects will be randomized in three consecutive multiple ascending dose cohorts of 8 subjects. The study will have 3 different doses of AEF0217 (0.6, 2 \& 6 mg) and 1 dose of matching placebo. Doses could be modified following the results of FIH-SAD. A given subject can be randomized only in one dose level cohort. PART III: A total of 12 healthy male subjects will be randomly assigned to one of two sequences in the crossover study part. All subjects will receive the same dose of AEF0117 which will be determined following the results of the FIH-SAD.
DRUG	Placebo	PART I: A total of 32 healthy male and female subjects will be randomized into four consecutive single ascending dose cohorts of 8 subjects. The study will have 4 different doses of AEF0217 (0.2, 0.6, 2 \& 6 mg) and 1 dose of matching placebo. A given subject can be randomized only in one dose level cohort. PART II: A total of 24 healthy subjects will be randomized in three consecutive multiple ascending dose cohorts of 8 subjects. The study will have 3 different doses of AEF0217 (0.6, 2 \& 6 mg) and 1 dose of matching placebo. Doses could be modified following the results of FIH-SAD. A given subject can be randomized only in one dose level cohort.

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-06-28
• Completion: 2022-06-28
• First posted: 2021-12-28
• Last updated: 2024-02-01

Locations

1 site across 1 country: Spain