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)
ILAb Co., Ltd.
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
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- Yes
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 la…
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.
Location
- ICON plc.Lenexa, Kansas