NCT05485779

SAD, MAD and Food Effect Evaluation of Safety, Tolerability, and PK of AQ280 in Healthy Subjects

A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose, and Food Effect Evaluation Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of AQ280 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: AQILION AB · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The principal aim of this study is to obtain safety and tolerability data when AQ280 is administered orally as single and multiple doses to healthy subjects. This information, together with the pharmacokinetic (PK) data, will help establish the doses and dosing regimen suitable for future studies in patients.

Conditions

• Eosinophilic Esophagitis (EoE)

Interventions

Type	Name	Description
DRUG	AQ280	Dose form: capsule, hard Strength: 3 to 100 mg Method of administration: oral
DRUG	Placebo	Active substance: none Dose form: capsule, hard Strength/dose: not applicable Method of administration: oral

Timeline

• Start date: 2022-07-20
• Primary completion: 2023-07-10
• Completion: 2023-07-10
• First posted: 2022-08-03
• Last updated: 2024-12-24
• Results posted: 2024-12-24

Locations

1 site across 1 country: United Kingdom