MAD Study of IA-14069

NCT05533372 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-05-20

No results posted yet for this study

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

Interventions

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.

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

More Related Trials

Entities

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 NCT05533372 on ClinicalTrials.gov