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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

NCT07266207 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2025-12-05

No results posted yet for this study

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.

Conditions

  • Rheumatoid Arthritis (RA)

Interventions

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.

Sponsors & Collaborators

  • Artivila (Shenzhen) Innovation Center, Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-16
Primary Completion
2025-08-14
Completion
2025-08-18

Countries

  • China

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07266207 on ClinicalTrials.gov