MAD Study of IA-14069
NCT05533372 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75
Last updated 2025-05-20
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.
Conditions
- Healthy
- Rheumatoid Arthritis
Interventions
- DRUG
-
IA-14069
IA-14069 for oral administration.
- DRUG
-
Placebo for oral administration.
- DRUG
-
Methotrexate
Methotrexate for oral or SC administration.
- DRUG
-
Methotrexate
Methotrexate for oral administration.
Sponsors & Collaborators
-
ILAb Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-10-10
- Primary Completion
- 2025-11-30
- Completion
- 2026-02-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
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