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New treatment option for Healthy
Official title MAD Study of IA-14069
ClinicalTrials.gov ID: NCT05533372
What this study is testing
What is IA-14069?
IA-14069 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for healthy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Sex : Males or females; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
- Age : 18 to 55 years, inclusive, for healthy people 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 people in Part 1 and 18 to 40 kg/m2, inclusive, for RA patients in Part 2, at...
- Weight : ≥ 50 kg, inclusive, at screening.
- Status : Healthy people for Part 1 and RA patients for Part 2.
You likely can't join 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 people 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...
- 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...
See the full eligibility criteria
Who can join
- Sex : Males or females; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
- Age : 18 to 55 years, inclusive, for healthy people 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 people 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 people 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 people/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...
- Male people/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...
- 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...
- 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...
- 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...
- Computerized 12-lead ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the Investigator. The ECG may be repeated if in the judgment of the...
- All values for clinical laboratory tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the Investigator. Clinical laboratory tests may be repeated at the discretion...
- Willing and able to sign the ICF. Main ; Part 2 in RA patients only:
- Treatment with oral or SC MTX 5 to 25 mg QW as a DMARD for at least 12 weeks prior to screening, and with a stable oral or SC dose for at least 4 weeks before screening, and that is expected to remain stable throughout...
- Having active RA, defined as:
- at least 6 swollen and 6 tender joints (based on 66/68 joint count), and
- CRP ≥ ULN or ESR ≥ ULN
What rules you out
- 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 people 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...
- Allergy or hypersensitivity to active ingredient or excipients.
- Using tobacco or nicotine products within 60 days prior to study drug administration (for people 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 drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], phencyclidine, cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, cotinine [only exclusionary in Part...
- 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.
- Chronic use of prescription or nonprescription drugs (including vitamins and dietary or herbal supplements) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives if known (whichever is...
- Patients receiving a biologic DMARD, or having received a biologic DMARD within 6 weeks or 5 half-lives if known (whichever is longer) prior to screening (Part 2 only).
- Patients receiving a targeted synthetic DMARD (including apremilast, baricitinib, filgotinib, or tofacitinib), or having received a targeted synthetic DMARD within 6 weeks or 5 half-lives (whichever is longer) prior to...
- Patients receiving a conventional synthetic DMARD (except MTX), or having received a conventional synthetic DMARD within 6 weeks or 5 half-lives (whichever is longer) prior to screening (Part 2 only).
- Strenuous activity, sunbathing, and contact sports within 48 hours (2 days) prior to admission to the clinical site through follow-up assessment.
- Consumption of any nutrients known to modulate CYP enzymes activity (eg, grapefruit or grapefruit juice, pomelo juice, star fruit, or Seville [blood] orange products) within 14 days prior to administration of study drug...
- Unable to comply with the safety monitoring requirements of this clinical study or is considered by the Investigator to be an unsuitable candidate for the study.
- Received a SARS-CoV-2 or any other vaccine within 7 days prior to dosing of study drug. Main exclusion criteria; Part 1 in healthy people only:
- Clinically significant hepatic impairment demonstrated by ALT, AST, total bilirubin, gamma-glutamyl transferase (GGT), and prothrombin time as judged by the Investigator at screening and on Day -1.
- Clinically significant renal impairment evidenced by estimated glomerular filtration rate (eGFR) calculated with the Chronic Kidney Disease EpidemiologyCollaboration (CKD-EPI) 2021, and protein in urine as judged by the...
- Patients with any single parameter of ALT, AST, GGT, or alkaline phosphatase (ALP) exceeding 2.5×ULN or total bilirubin exceeding 1.5×ULN OR any elevation above ULN of more than one parameter of ALT, AST, GGT, ALP, or...
- Patients with eGFR value calculated with the CKD-EPI 2021 \<60 mL/min/1.73m2 at screening and on Day -3.
The study team makes the final eligibility decision.
Where it's taking place
- Lenexa, Kansas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lenexa, Kansas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.