MAD Study of IA-14069

NCT05533372 | Recruiting Phase 1 FDA Drug

• 1 other identifier: IA-14069_1b
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidnece and severity of adverse events

  Incidence and severity of adverse events (AEs) and serious AEs, including clinical laboratory values, vital signs, 12-lead electrocardiograms, and physical examination; changes from baseline.

  up to Day 35

Secondary Outcomes (6)

• Cmax

  up to Day 28

• Tmax

  up to Day 28

• AUC

  up to Day 28

• t1/2el

  up to Day 28

• CL/F

  up to Day 28

Other Outcomes (2)

• Change from baseline in concentration of Tumor necrosis factor in blood

  up to Day 28

• Change from baseline in disease activity scores

  up to Day 28

Study Arms (3)

IA-14069 MAD

EXPERIMENTAL

Subjects will be administrated multiple oral doses of IA-14069 at three ascending dose levels or matching placebo for 10 days.

Drug: IA-14069; Drug: Placebo

IA-14069 DDI

EXPERIMENTAL

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.

Drug: IA-14069; Drug: Placebo; Drug: Methotrexate

IA-14069 MAD RA patients

EXPERIMENTAL

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.

Drug: IA-14069; Drug: Placebo; Drug: Methotrexate

Interventions

IA-14069 DRUG

IA-14069 for oral administration.

IA-14069 DDI; IA-14069 MAD; IA-14069 MAD RA patients

Placebo DRUG

Placebo for oral administration.

IA-14069 DDI; IA-14069 MAD; IA-14069 MAD RA patients

Methotrexate DRUG

Methotrexate for oral or SC administration.

IA-14069 MAD RA patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sex : Males or females; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
• Age : 18 to 55 years, inclusive, for healthy subjects in Part 1 and 18 to 70 years, inclusive, for RA patients in Part 2, at screening.
• Body mass index (BMI) : 18 to 32 kg/m2, inclusive, for healthy subjects in Part 1 and 18 to 40 kg/m2, inclusive, for RA patients in Part 2, at screening.
• Weight : ≥ 50 kg, inclusive, at screening.
• Status : Healthy subjects for Part 1 and RA patients for Part 2.
• At screening, females must not be pregnant or lactating.
• At screening, females may be of nonchildbearing potential, either surgically sterilized, physiologically incapable of becoming pregnant, or postmenopausal.
• Female subjects/patients of childbearing potential who have a fertile male sexual partner (ie, not surgically sterilized for at least 6 months prior to screening) must agree to use adequate contraception from at least 4 weeks prior to administration of the study drug until 90 days after the last dosing of study drug.
• Male subjects/patients, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from admission to the clinical site until 90 days after the last dosing of study drug.
• Non-use of all over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before administration of study drug until completion of the follow-up assessment, unless, judged by the Investigator in consultation with the Medical Monitor and the Sponsor that the medication will not interfere with the study drug.
• Ability and willingness to abstain from alcohol from 72 hours (3 days) prior to each admission to the clinical site and until discharge.
• For North America only: Ability and willingness to abstain from caffeine, and methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, or energy drinks) from 72 hours (3 days) prior to each admission to the clinical site and until discharge.
• For EU only: Ability and willingness to abstain from caffeine, and methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, or energy drinks) from 48 hours (2 days) prior to each admission to the clinical site and until discharge.
• Good physical and mental health on the basis of medical history (except for RA medical history in Part 2 of the study), physical examinations, clinical laboratory tests, 12-lead ECG, and vital signs, as judged by the Investigator.
• Resting supine blood pressure showing no clinically relevant deviations as judged by the Investigator. If initial results do not meet these criteria, blood pressure and/or pulse may be repeated if in the judgment of the Investigator there is a reason to believe the initial result is inaccurate (eg, white coat hypertension).

You may not qualify if:

• Previous participation in the SAD study (Study IA-14069\_1a).
• Employee of ICON or the Sponsor.
• Use of any investigational drug or device within 30 days (or 5 half-lives if known, whichever is longer) prior to admission.
• Any disease which, in the opinion of the Investigator, poses an unacceptable risk to the subjects or patients.
• Females who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after the last dosing of study drug.
• Males with female partners who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after the last dosing of study drug.
• History of relevant drug sensitivity, and/or food allergies, as determined by the Investigator (such as anaphylaxis, hepatotoxicity, or treatment with steroids or epinephrine). Confirmatory circumstances would include treatment with epinephrine or in Emergency Department.
• Allergy or hypersensitivity to active ingredient or excipients.
• Using tobacco or nicotine products within 60 days prior to study drug administration (for subjects in Part 1).
• History within the previous 12 months of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink=12 oz beer, 5 oz wine, and 1.5 oz spirits).
• Positive screen for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) antibodies, or HIV-1 and -2 antibodies.
• Donation or loss of more than 450 mL of blood within 60 days prior to study drug administration, or planned donation before 30 days has elapsed after the last dosing of study drug.
• Plasma or platelet donation within 7 days prior to study drug administration through follow-up assessment.
• Significant and/or acute illness within 5 days prior to drug administration that may impact safety assessments, in the opinion of the Investigator.
• Unsuitable veins for blood sampling.

Sponsors & Collaborators

• ILAb Co., Ltd.: lead

Study Sites (1)

ICON plc.

Lenexa, Kansas, 66219, United States

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Tae-Hwe Heo, Ph.D.

CONTACT

+82-10-4596-2447; taehwe.heo@ilab.co.kr

Youjin Jang, M.S.

CONTACT

+82-10-4300-0206; youjin.jang@ilab.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 9, 2022
• Study Start: October 10, 2022
• Primary Completion: November 1, 2025
• Study Completion: February 1, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

US (1)