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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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)

MAD Study of IA-14069 (NCT05533372) is a Phase 1 interventional studying Healthy and Rheumatoid Arthritis, sponsored by ILAb Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Healthy, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 75 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Healthy subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Sex : Males or females; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal. 2. Age : 18 to 55 years, inclusive, for healthy subjects in Part 1 and 18 to 70 years, inclusive, for RA patients in Part 2, at screening. 3. Body mass index (BMI) : 18 to 32 kg/m2, inclusive, for healthy subjects in Part 1 and 18 to 40 kg/m2, inclusive, for RA patients in Part 2, at screening. 4. Weight : ≥ 50 kg, inclusive, at screening. 5. Status : Healthy subjects for Part 1 and RA patients for Part 2. 6. At screening, females must not be pregnant or lactating. 7. At screening, females may be of nonchildbearing potential, either surgically sterilized, physiologically incapable of becoming pregnant, or postmenopausal. 8. Female subjects/patients of childbearing potential who have a fertile male sexual partner (ie, not surgically sterilized for at least 6 months prior to screening) must agree to use adequate contraception from at least 4 weeks prior to administration of the study drug until 90 days after the last dosing of study drug. 9. Male subjects/patients, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from admission to the clinical site until 90 days after the last dosing of study drug. 10. Non-use of all over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before administration of study drug until completion of the follow-up assessment, unless, judged by the Investigator in consultation with the Medical Monitor and the Sponsor that the medication will not interfere with the study drug. 11. Ability and willingness to abstain from alcohol from 72 hours (3 days) prior to each admission to the clinical site and until discharge. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Sex : Males or females; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal. 2. Age : 18 to 55 years, inclusive, for healthy subjects in Part 1 and 18 to 70 years, inclusive, for RA patients in Part 2, at screening. 3. Body mass index (BMI) : 18 to 32 kg/m2, inclusive, for healthy subjects in Part 1 and 18 to 40 kg/m2, inclusive, for RA patients in Part 2, at screening. 4. Weight : ≥ 50 kg, inclusive, at screening. 5. Status : Healthy subjects for Part 1 and RA patients for Part 2. 6. At screening, females must not be pregnant or lactating. 7. At screening, females may be of nonchildbearing potential, either surgically sterilized, physiologically incapable of becoming pregnant, or postmenopausal. 8. Female subjects/patients of childbearing potential who have a fertile male sexual partner (ie, not surgically sterilized for at least 6 months prior to screening) must agree to use adequate contraception from at least 4 weeks prior to administration of the study drug until 90 days after the last dosing of study drug. 9. Male subjects/patients, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from admission to the clinical site until 90 days after the last dosing of study drug. 10. Non-use of all over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before administration of study drug until completion of the follow-up assessment, unless, judged by the Investigator in consultation with the Medical Monitor and the Sponsor that the medication will not interfere with the study drug. 11. Ability and willingness to abstain from alcohol from 72 hours (3 days) prior to each admission to the clinical site and until discharge. For North America only: Ability and willingness to abstain from caffeine, and methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, or energy drinks) from 72 hours (3 days) prior to each admission to the clinical site and until discharge. For EU only: Ability and willingness to abstain from caffeine, and methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, or energy drinks) from 48 hours (2 days) prior to each admission to the clinical site and until discharge. 12. Good physical and mental health on the basis of medical history (except for RA medical history in Part 2 of the study), physical examinations, clinical laboratory tests, 12-lead ECG, and vital signs, as judged by the Investigator. 13. Resting supine blood pressure showing no clinically relevant deviations as judged by the Investigator. If initial results do not meet these criteria, blood pressure and/or pulse may be repeated if in the judgment of the Investigator there is a reason to believe the initial result is inaccurate (eg, white coat hypertension). 14. Computerized 12-lead ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the Investigator. The ECG may be repeated if in the judgment of the Investigator there is a reason to believe the initial result is inaccurate. 15. All values for clinical laboratory tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the Investigator. Clinical laboratory tests may be repeated at the discretion of the Investigator. 16. Willing and able to sign the ICF. Main inclusion criteria; Part 2 in RA patients only: 17. Treatment with oral or SC MTX 5 to 25 mg QW as a DMARD for at least 12 weeks prior to screening, and with a stable oral or SC dose for at least 4 weeks before screening, and that is expected to remain stable throughout the study period. 18. Having active RA, defined as: * at least 6 swollen and 6 tender joints (based on 66/68 joint count), and * CRP ≥ ULN or ESR ≥ ULN Exclusion Criteria: 1. Previous participation in the SAD study (Study IA-14069\_1a). 2. Employee of ICON or the Sponsor. 3. Use of any investigational drug or device within 30 days (or 5 half-lives if known, whichever is longer) prior to admission. 4. Any disease which, in the opinion of the Investigator, poses an unacceptable risk to the subjects or patients. 5. Females who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after the last dosing of study drug. 6. Males with female partners who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after the last dosing of study drug. 7. History of relevant drug sensitivity, and/or food allergies, as determined by the Investigator (such as anaphylaxis, hepatotoxicity, or treatment with steroids or epinephrine). Confirmatory circumstances would include treatment with epinephrine or in Emergency Department. 8. Allergy or hypersensitivity to active ingredient or excipients. 9. Using tobacco or nicotine products within 60 days prior to study drug administration (for subjects in Part 1). 10. History within the previous 12 months of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink=12 oz beer, 5 oz wine, and 1.5 oz spirits). 11. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines \[including ecstasy\], phencyclidine, cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, cotinine \[only exclusionary in Part 1\], and alcohol) at screening or admission to the clinical site. 12. Positive screen for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) antibodies, or HIV-1 and -2 antibodies. 13. Donation or loss of more than 450 mL of blood within 60 days prior to study drug administration, or planned donation before 30 days has elapsed after the last dosing of study drug. 14. Plasma or platelet donation within 7 days prior to study drug administration through follow-up assessment. 15. Significant and/or acute illness within 5 days prior to drug administration that may impact safety assessments, in the opinion of the Investigator. 16. Unsuitable veins for blood sampling. 17. Chronic use of prescription or nonprescription drugs (including vitamins and dietary or herbal supplements) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives if known (whichever is longer) prior to the first dosing (except oral or SC MTX, oral glucocorticoid \[prednisone ≤ 10 mg/day or equivalent; this exception is allowed if stable for at least 3 months prior to screening and expected to remain stable throughout the study period\], folic acid and/or folinic acid in Part 2), but considered on a case-by-case basis by the Investigator in consultation with the Medical Monitor and the Sponsor. 18. Patients receiving a biologic DMARD, or having received a biologic DMARD within 6 weeks or 5 half-lives if known (whichever is longer) prior to screening (Part 2 only). 19. Patients receiving a targeted synthetic DMARD (including apremilast, baricitinib, filgotinib, or tofacitinib), or having received a targeted synthetic DMARD within 6 weeks or 5 half-lives (whichever is longer) prior to screening (Part 2 only). 20. Patients receiving a conventional synthetic DMARD (except MTX), or having received a conventional synthetic DMARD within 6 weeks or 5 half-lives (whichever is longer) prior to screening (Part 2 only). 21. Strenuous activity, sunbathing, and contact sports within 48 hours (2 days) prior to admission to the clinical site through follow-up assessment. 22. Consumption of any nutrients known to modulate CYP enzymes activity (eg, grapefruit or grapefruit juice, pomelo juice, star fruit, or Seville \[blood\] orange products) within 14 days prior to administration of study drug and during the study. 23. Unable to comply with the safety monitoring requirements of this clinical study or is considered by the Investigator to be an unsuitable candidate for the study. 24. Received a SARS-CoV-2 or any other vaccine within 7 days prior to dosing of study drug. Main exclusion criteria; Part 1 in healthy subjects only: 25. Clinically significant hepatic impairment demonstrated by ALT, AST, total bilirubin, gamma-glutamyl transferase (GGT), and prothrombin time as judged by the Investigator at screening and on Day -1. 26. Clinically significant renal impairment evidenced by estimated glomerular filtration rate (eGFR) calculated with the Chronic Kidney Disease EpidemiologyCollaboration (CKD-EPI) 2021, and protein in urine as judged by the Investigator at screening and on Day -1. Main exclusion criteria; Part 2 in RA patients only: 27. Patients with any single parameter of ALT, AST, GGT, or alkaline phosphatase (ALP) exceeding 2.5×ULN or total bilirubin exceeding 1.5×ULN OR any elevation above ULN of more than one parameter of ALT, AST, GGT, ALP, or serum bilirubin at screening and on Day -3. 28. Patients with eGFR value calculated with the CKD-EPI 2021 \<60 mL/min/1.73m2 at screening and on Day -3.

Treatments Being Tested

DRUG

IA-14069

IA-14069 for oral administration.

DRUG

Placebo

Placebo for oral administration.

DRUG

Methotrexate

Methotrexate for oral or SC administration.

DRUG

Methotrexate

Methotrexate for oral administration.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

ICON plc.
Lenexa, Kansas, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05533372), the sponsor (ILAb Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05533372 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05533372?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05533372?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05533372. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05533372. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.