HealthyPhase 1NCT05533372
MAD Study of IA-14069
A Phase 1 study testing IA-14069 and Methotrexate in people with Healthy and Rheumatoid Arthritis, run by ILAb Co., Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Rheumatoid Arthritis
- What is being tested?
- IA-14069 and Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2022to 15 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sex : Males or females; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
- 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.
- 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.
- Weight : ≥ 50 kg, inclusive, at screening.
- Status : Healthy subjects for Part 1 and RA patients for Part 2.
- At screening, females must not be pregnant or lactating.
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- At screening, females may be of nonchildbearing potential, either surgically sterilized, physiologically incapable of becoming pregnant, or postmenopausal.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- Willing and able to sign the ICF.
- Main inclusion criteria; Part 2 in RA patients only:
- 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.
- 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
Who cannot join
- Previous participation in the SAD study (Study IA-14069_1a).
- Employee of ICON or the Sponsor.
- Use of any investigational drug or device within 30 days (or 5 half-lives if known, whichever is longer) prior to admission.
- Any disease which, in the opinion of the Investigator, poses an unacceptable risk to the subjects or patients.
- 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.
- 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.
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- 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.
- Allergy or hypersensitivity to active ingredient or excipients.
- Using tobacco or nicotine products within 60 days prior to study drug administration (for subjects in Part 1).
- 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).
- 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.
- Positive screen for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) antibodies, or HIV-1 and -2 antibodies.
- 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.
- Plasma or platelet donation within 7 days prior to study drug administration through follow-up assessment.
- Significant and/or acute illness within 5 days prior to drug administration that may impact safety assessments, in the opinion of the Investigator.
- Unsuitable veins for blood sampling.
- 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.
- 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).
- 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).
- 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).
- Strenuous activity, sunbathing, and contact sports within 48 hours (2 days) prior to admission to the clinical site through follow-up assessment.
- 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.
- 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.
- 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:
- 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.
- Clinically significant renal impairment evidenced by estimated glomerular filtration rate (eGFR) calculated with the Chronic Kidney Disease Epidemiology Collaboration (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:
- 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.
- Patients with eGFR value calculated with the CKD-EPI 2021 <60 mL/min/1.73m2 at screening and on Day -3.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
- Conditions
- Healthy, Rheumatoid Arthritis
- Being tested
- IA-14069, Placebo, Methotrexate
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IA-14069Drug
IA-14069 for oral administration.
PlaceboDrug
Placebo for oral administration.
MethotrexateDrug
Methotrexate for oral or SC administration.
MethotrexateDrug
Methotrexate for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| IA-14069 MAD | Experimental | Subjects will be administrated multiple oral doses of IA-14069 at three ascending dose levels or matching placebo for 10 days. Receives: Drug: IA-14069; Drug: Placebo |
| IA-14069 DDI | Experimental | Subjects will be administrated multiple oral doses of IA-14069 at three ascending dose levels or matching placebo for 10 days.
On day 11, subjects will be adminiatrated oral dose of IA-14069 or matching placebo with methotrexate.
On day 21, subjects will be administrated methotrexate alone. Receives: Drug: IA-14069; Drug: Placebo; Drug: Methotrexate |
| IA-14069 MAD RA patients | Experimental | Patients will be administrated multiple oral doses of IA-14069 at three ascending dose levels or matching placebo for 28 days.
Patients will be on a stable dose of methotrexate throughout the study period. Receives: Drug: IA-14069; Drug: Placebo; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidnece and severity of adverse events
Incidence and severity of adverse events (AEs) and serious AEs, including clinical laboratory values, vital signs, 12-lead electrocardiograms, and physical examination; changes from baseline.
Measured: up to Day 35
Secondary outcomes (6)
Cmax
Maximum ovserved plasma concentration of IA-14069 and/or methotrexate
Measured: up to Day 28
Tmax
Time to attain maximum observed plasma concentration of IA-14069 and/or methotrexate
Measured: up to Day 28
AUC
Area under the plasma concentration time curve of IA-14069 and/or methotrexate
Measured: up to Day 28
t1/2el
Terminal elimination half-life of IA-14069 and/or methotrexate
Measured: up to Day 28
CL/F
Apparent clearance (CL/F) of IA-14069
Measured: up to Day 28
VD/F
Apparent volume of distribution (Vd/F) of IA-14069
Measured: up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start10 Oct 2022
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- ILAb Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533372
- Sponsor's protocol ID
- IA-14069_1b
- Status last verified
- Aug 2026
- First submitted
- 5 Sep 2022
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05533372
- Acronym / sponsor ID
- IA-14069_1b
- Conditions
- Healthy, Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- ILAb Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 9 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IA-14069 MAD | Experimental | Drug: IA-14069, Drug: PlaceboSubjects will be administrated multiple oral doses of IA-14069 at three ascending dose levels or matching placebo for 10 days. |
| IA-14069 DDI | Experimental | Drug: IA-14069, Drug: Placebo, Drug: MethotrexateSubjects will be administrated multiple oral doses of IA-14069 at three ascending dose levels or matching placebo for 10 days. On day 11, subjects will be adminiatrated oral dose of IA-14069 or matching placebo with methotrexate. On day 21, subjects will be administrated methotrexate alone. |
| IA-14069 MAD RA patients | Experimental | Drug: IA-14069, Drug: Placebo, Drug: MethotrexatePatients will be administrated multiple oral doses of IA-14069 at three ascending dose levels or matching placebo for 28 days. Patients will be on a stable dose of methotrexate throughout the study period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Sex : Males or females; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
- 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.
- 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.
- Weight : ≥ 50 kg, inclusive, at screening.
- Status : Healthy subjects for Part 1 and RA patients for Part 2.
Key exclusion criteria (30 listed)
- Previous participation in the SAD study (Study IA-14069_1a).
- Employee of ICON or the Sponsor.
- Use of any investigational drug or device within 30 days (or 5 half-lives if known, whichever is longer) prior to admission.
- Any disease which, in the opinion of the Investigator, poses an unacceptable risk to the subjects or patients.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IA-14069IA-14069 for oral administration. | Drug | IA-14069 DDI, IA-14069 MAD, IA-14069 MAD RA patients |
| PlaceboPlacebo for oral administration. | Drug | IA-14069 DDI, IA-14069 MAD, IA-14069 MAD RA patients |
| MethotrexateMethotrexate for oral or SC administration. | Drug | IA-14069 MAD RA patients |
| MethotrexateMethotrexate for oral administration. | Drug | IA-14069 DDI |
Primary outcome
Incidnece and severity of adverse events
Time frame: up to Day 35
Incidence and severity of adverse events (AEs) and serious AEs, including clinical laboratory values, vital signs, 12-lead electrocardiograms, and physical examination; changes from baseline.
6 secondary outcomes
Cmax
Time frame: up to Day 28
Tmax
Time frame: up to Day 28
AUC
Time frame: up to Day 28
t1/2el
Time frame: up to Day 28
CL/F
Time frame: up to Day 28
VD/F
Time frame: up to Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IA-14069 and Methotrexate in people with Healthy and Rheumatoid Arthritis, run by ILAb Co., Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidnece and severity of adverse events (time frame: up to Day 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.