MAD Study of IA-14069
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.
| Condition(s) | Healthy, Rheumatoid Arthritis |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 ch |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | ILAb Co., Ltd. |
| Locations | Lenexa, Kansas, United States |
| Start date | 2022-10-10 |
| NCT ID | NCT05533372 |
| Official listing | https://clinicaltrials.gov/study/NCT05533372 |