NCT05533372

MAD Study of IA-14069

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: ILAb Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	IA-14069	IA-14069 for oral administration.
DRUG	Placebo	Placebo for oral administration.
DRUG	Methotrexate	Methotrexate for oral or SC administration.
DRUG	Methotrexate	Methotrexate for oral administration.

Timeline

• Start date: 2022-10-10
• Primary completion: 2025-11-01
• Completion: 2026-02-01
• First posted: 2022-09-09
• Last updated: 2025-05-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study