NCT07266207

Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetic, and Food Effects of ARD-885 Film-coated Tablets in Healthy Chinese Subjects and Patients With Rheumatoid Arthritis

A Randomized, Double-blind, Placebo-controlled Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Food Effects of ARD-885 Film-coated Tablets in Healthy Chinese Subjects and Patients With Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Artivila (Shenzhen) Innovation Center, Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The proposed study is a randomized, double-blind, placebo-controlled single and multiple ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetic, and food effects of ARD-885 Film-coated Tablets in healthy subjects.The entire study includes 3 parts: a single ascending dose study, a multiple ascending dose study, and a food-effect bioavailability study in healthy subjects.

Detailed description

The whole study includes 3 parts: a single ascending dose study, a multiple ascending dose study, and a food-effect bioavailability study. The SAD and MAD studies are randomized, double-blinded, and placebo-controlled studies, and the FE study is a randomized, open-label, two-period, two-treatment (2×2) crossover study.

Conditions

• Rheumatoid Arthritis (RA)

Interventions

Type	Name	Description
DRUG	ARD-885 Tablets	ARD-885 Tablet is a dual-target inhibitor of IRAK4 and IRAK1.
DRUG	ARD-885 Placebo Tablet	Placebo Tablet to ARD-885 tablets.

Timeline

• Start date: 2024-12-16
• Primary completion: 2025-08-14
• Completion: 2025-08-18
• First posted: 2025-12-05
• Last updated: 2025-12-05

Locations

1 site across 1 country: China