Actively Recruiting
Phase 1
Age: 18Years - 70Years
All Genders
Healthy Volunteers
NCT05533372
MAD Study of IA-14069
Led by ILAb Co., Ltd. · Updated on 2025-05-20
75
Participants Needed
1
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
MAD Study of IA-14069
Who Can Participate
Age: 18Years - 70Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Male or female participants; females may be of childbearing potential, nonchildbearing potential, or postmenopausal
- Age 18 to 55 years for healthy subjects (Part 1) and 18 to 70 years for RA patients (Part 2)
- Body mass index (BMI) 18 to 32 kg/m2 for healthy subjects and 18 to 40 kg/m2 for RA patients
- Weight of at least 50 kg
- Healthy subjects for Part 1; rheumatoid arthritis patients for Part 2
- Females must not be pregnant or lactating at screening
- Females of nonchildbearing potential must be surgically sterilized, physiologically incapable of becoming pregnant, or postmenopausal
- Female participants of childbearing potential with fertile male partners must use adequate contraception from 4 weeks before until 90 days after last dosing
- Male participants who are not surgically sterilized must use adequate contraception and avoid sperm donation from admission until 90 days after last dosing
- No use of over-the-counter medications, vitamins, supplements, or herbal medications within 7 days (or 14 days if enzyme inducer) before dosing until follow-up, unless approved by Investigator
- Ability and willingness to abstain from alcohol and caffeine (with timing depending on region) before admission and until discharge
- Good physical and mental health based on medical history, exams, lab tests, ECG, and vital signs
- Blood pressure and ECG within normal or acceptable ranges as judged by Investigator
- Laboratory blood and urine tests within normal or acceptable ranges
- Willing and able to sign informed consent
- For RA patients: treatment with stable oral or subcutaneous methotrexate (5 to 25 mg weekly) for at least 12 weeks prior to screening
- For RA patients: active rheumatoid arthritis defined by at least 6 swollen and 6 tender joints and elevated CRP or ESR
You will not qualify if you...
- Previous participation in the SAD study (IA-14069_1a)
- Employment by ICON or the Sponsor
- Use of investigational drugs or devices within 30 days prior to admission
- Any disease posing unacceptable risk per Investigator
- Females who are pregnant, lactating, or planning pregnancy during study or within 90 days after last dosing
- Males with female partners who are pregnant, lactating, or planning pregnancy during study or within 90 days after last dosing
- History of relevant drug sensitivity or food allergies requiring emergency treatment
- Allergy or hypersensitivity to the study drug or excipients
- Use of tobacco or nicotine products within 60 days prior to dosing (Part 1 only)
- Excessive alcohol consumption in past 12 months
- Positive drug or alcohol screening at screening or admission
- Positive screening for hepatitis B, hepatitis C, or HIV
- Blood donation or loss >450 mL within 60 days prior to dosing
- Plasma or platelet donation within 7 days prior to dosing
- Significant acute illness within 5 days prior to dosing
- Unsuitable veins for blood sampling
- Chronic use of prescription or nonprescription drugs within 7 days (or 14 days if enzyme inducer) except allowed drugs
- Use of biologic, targeted synthetic, or conventional synthetic DMARDs other than methotrexate within specified washout periods (Part 2 only)
- Strenuous activity, sunbathing, or contact sports within 48 hours prior to admission
- Consumption of foods known to affect CYP enzymes within 14 days prior to dosing
- Inability to comply with safety monitoring or considered unsuitable by Investigator
- Receipt of SARS-CoV-2 or other vaccines within 7 days prior to dosing
- Clinically significant hepatic or renal impairment for healthy subjects (Part 1)
- Elevated liver enzymes or reduced kidney function for RA patients (Part 2)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Trial Site Locations
Total: 1 location
1
ICON plc.
Lenexa, Kansas, United States, 66219
Actively Recruiting
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Research Team
T
Tae-Hwe Heo, Ph.D.
CONTACT
Y
Youjin Jang, M.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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