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)
Overview
- Phase
- Phase 1
- Intervention
- IA-14069
- Conditions
- Healthy
- Sponsor
- ILAb Co., Ltd.
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Incidnece and severity of adverse events
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •At screening, females must not be pregnant or lactating.
- •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.
Exclusion Criteria
- •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.
- •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).
Arms & Interventions
IA-14069 MAD
Subjects will be administrated multiple oral doses of IA-14069 at three ascending dose levels or matching placebo for 10 days.
Intervention: IA-14069
IA-14069 MAD
Subjects will be administrated multiple oral doses of IA-14069 at three ascending dose levels or matching placebo for 10 days.
Intervention: Placebo
IA-14069 DDI
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.
Intervention: IA-14069
IA-14069 DDI
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.
Intervention: Placebo
IA-14069 DDI
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.
Intervention: Methotrexate
IA-14069 MAD RA patients
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.
Intervention: IA-14069
IA-14069 MAD RA patients
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.
Intervention: Placebo
IA-14069 MAD RA patients
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.
Intervention: Methotrexate
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- t1/2el(up to Day 28)
- CL/F(up to Day 28)
- Cmax(up to Day 28)
- AUC(up to Day 28)
- VD/F(up to Day 28)
- Tmax(up to Day 28)