RecruitingPhase 1NCT05533372

MAD Study of IA-14069

Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IA-14069 in Healthy Subjects, With an Extension to Explore Any Drug-Drug Interaction Potential With Methotrexate (Part 1), and in Patients With Rheumatoid Arthritis, With Preliminary Assessment of Efficacy in Patients (Part 2)


Sponsor

ILAb Co., Ltd.

Enrollment

75 participants

Start Date

Oct 10, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple ascending oral doses of IA-14069 in healthy subjects and in patients with RA on stable dosese of MTX, with preliminary assessment of efficacy in RA patients.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing the safety and dosing of a new investigational drug called IA-14069 in two groups: healthy volunteers (Part 1) and people with rheumatoid arthritis (RA) (Part 2). The study measures how the drug behaves in the body at different dose levels. **You may be eligible if...** - You are 18–55 (healthy volunteers) or 18–70 (RA patients) - Your BMI is 18–32 (healthy volunteers) or 18–40 (RA patients) - You weigh at least 50 kg - Healthy volunteers must be in good general health; RA patients must have a confirmed RA diagnosis - You are not pregnant or breastfeeding and agree to use contraception during and for 90 days after the study **You may NOT be eligible if...** - You are pregnant or planning to become pregnant - You have taken over-the-counter medications, vitamins, or herbal supplements (like St. John's wort) within 7 days before the study - You have other significant medical conditions that could interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIA-14069

IA-14069 for oral administration.

DRUGPlacebo

Placebo for oral administration.

DRUGMethotrexate

Methotrexate for oral or SC administration.

DRUGMethotrexate

Methotrexate for oral administration.


Locations(1)

ICON plc.

Lenexa, Kansas, United States

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NCT05533372


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