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To Evaluate the Safety, Pharmacokinetic and the Effect of Food After Administration of ABN401 in Healthy Adult Volunteers

NCT05248074 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-02-20

No results posted yet for this study

Summary

This randomized open-label, two-way crossover study is designed to evaluate the safety and pharmacokinetic characteristics of ABN401, and the effect of high-fat meal on the pharmacokinetic profiles of ABN401 and its metabolites in healthy adult volunteers.

Conditions

Interventions

OTHER

High-fat meal (over 900 kcal)

High-fat meal (over 900 kcal with over 35 percent fat content of total calorie) will be provided prior to IP administration. The IP will then be administered 30 minutes after the subject begins the meal.

DRUG

ABN401 (investigational product)

The investigational product, ABN401 800 mg (3 x 250 mg + 2 x 25 mg) will be administered orally with approximately 240 mL of water in fasted or fed condition in accordance with the order of IP administration in an allocated sequence.

Sponsors & Collaborators

  • Abion Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-04
Primary Completion
2022-02-18
Completion
2022-10-18

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT05248074 on ClinicalTrials.gov