MAD Study of IA-14069

Part of paid clinical trials in Lenexa, Kansas.

Sponsor
ILAb Co., Ltd.
Study ID
NCT05533372
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • IA-14069 — DRUG
    IA-14069 for oral administration.
  • Placebo — DRUG
    Placebo for oral administration.
  • Methotrexate — DRUG
    Methotrexate for oral or SC administration.
  • Methotrexate — DRUG
    Methotrexate for oral administration.

Study Details

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.

Key Dates

Start date
Oct 10, 2022
Status verified
May 2025
Primary completion
Nov 30, 2025
Completion
Feb 28, 2026

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: IA-14069 MAD
    Subjects will be administrated multiple oral doses of IA-14069 at three ascending dose levels or matching placebo for 10 days.
  • Experimental: IA-14069 DDI
    Subjects will be administrated multiple oral doses of IA-14069 at three ascending dose levels or matching placebo for 10 days. On day 11, subjects will be adminiatrated oral dose of IA-14069 or matching placebo with methotrexate. On day 21, subjects will be administrated methotrexate alone.
  • Experimental: IA-14069 MAD RA patients
    Patients will be administrated multiple oral doses of IA-14069 at three ascending dose levels or matching placebo for 28 days. Patients will be on a stable dose of methotrexate throughout the study period.

Primary Outcome Measure

Incidnece and severity of adverse events [ Time Frame: up to Day 35 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
ICON plc.LenexaKansas66219-

Find similar trials in Lenexa, KS

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
ICON plc.· Lenexa, KS

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