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

NCT05485779 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-12-24

Study results available
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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

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

Sponsors & Collaborators

  • AQILION AB

    lead INDUSTRY

Principal Investigators

  • Jan Törnell, MD, PhD · AQILION AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-20
Primary Completion
2023-07-10
Completion
2023-07-10

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05485779 on ClinicalTrials.gov