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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

Study of LFD-200 in Healthy Adults and Adults With Moderate to Severe Rheumatoid Arthritis

A Phase 1a/1b, Randomized, Double-Blind, Placebo- and Active-Controlled, Single and Multiple Ascending Dose Study Evaluating the Comparative Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LFD-200 in Adult Participants Who Are Healthy or Have Moderate to Severe Rheumatoid Arthritis

Study of LFD-200 in Healthy Adults and Adults With Moderate to Severe Rheumatoid Arthritis (NCT07207954) is a Phase 1 interventional studying Rheumatoid Arthritis, sponsored by Lifordi Immunotherapeutics, Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a double-blind, randomized, placebo- and active-controlled study investigating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous (SC) doses of LFD-200. The study design includes: a single ascending dose (SAD) study in up to 66 adult healthy participants (HPs) to investigate the effects of a single SC dose, with a 30-day follow-up; a multiple ascending dose (MAD) study in up to 40 HPs to assess up to 4 weekly SC doses, with a 30-day follow-up after the last dose; and a MAD study in up to 70 participants with moderate to severe rheumatoid arthritis (RA) to evaluate up to 13 weekly SC doses, with a 30-day follow-up after the last dose.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Rheumatoid Arthritis, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 176 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Rheumatoid Arthritis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Inclusion Criteria for Healthy Participants: - Age 18-55 - BMI - 18-32 - Participants must be deemed by the Investigator to be generally healthy individuals based on a medical evaluation that includes a physical examination, medical history, vital signs, and the results from clinical labs and other safety assessments collected during the Screening period. Exclusion Criteria for Healthy Participants: - Participants with any current or previous illness that, in the opinion of the investigator, might confound the results of the study or pose an additional, unacceptable risk to the participant or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation. - Recent serious or ongoing infection - Known/suspected primary weakened immune system - Receipt of injected or systemic glucocorticoids within 6 weeks prior to screening - Use of prohibited medications - Any of the following lab abnormalities: - White blood cell (WBC) count \<3.0 x 109/L - Absolute neutrophil count (ANC) \<2.0 x 109/L - Hemoglobin (Hgb) \<12.5 g/dL for males and \<11.5 g/dL for females - Platelet count \<140 x 109/L - Alanine transaminase (ALT) ≥1.2x upper limit of normal (ULN) - Total bilirubin ≥1.2x ULN (except if Gilbert's disease is suspected etiology) - Estimated glomerular filtration rate (eGFR) \<80 mL/min/1.73m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI 2021) formula. - International normalized ratio (INR) ≥1.2 × ULN - Glycated hemoglobin (HbA1c) \>6% - Positive urine cotinine test (Day -1 only), alcohol breath test or urine drug screen for substances of abuse. Positive tetrahydrocannabinol (THC) is not exclusionary. - A Screening thyroid stimulating hormone (TSH) level that is \<0.9 × lower limit normal (LLN) or ≥1.2 × ULN - Cortisol level \<1.0 × LLN (Collected in the AM at the Baseline Visit) Inclusion Criteria for RA Participants: - Adults of age 18 to 75 years, inclusive, at the time of signing the ICF. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria for Healthy Participants: * Age 18-55 * BMI - 18-32 * Participants must be deemed by the Investigator to be generally healthy individuals based on a medical evaluation that includes a physical examination, medical history, vital signs, and the results from clinical labs and other safety assessments collected during the Screening period. Exclusion Criteria for Healthy Participants: * Participants with any current or previous illness that, in the opinion of the investigator, might confound the results of the study or pose an additional, unacceptable risk to the participant or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation. * Recent serious or ongoing infection * Known/suspected primary immunodeficiency * Receipt of injected or systemic glucocorticoids within 6 weeks prior to screening * Use of prohibited medications * Any of the following lab abnormalities: * White blood cell (WBC) count \<3.0 x 109/L * Absolute neutrophil count (ANC) \<2.0 x 109/L * Hemoglobin (Hgb) \<12.5 g/dL for males and \<11.5 g/dL for females * Platelet count \<140 x 109/L * Alanine transaminase (ALT) ≥1.2x upper limit of normal (ULN) * Total bilirubin ≥1.2x ULN (except if Gilbert's disease is suspected etiology) * Estimated glomerular filtration rate (eGFR) \<80 mL/min/1.73m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI 2021) formula. * International normalized ratio (INR) ≥1.2 × ULN * Glycated hemoglobin (HbA1c) \>6% * Positive urine cotinine test (Day -1 only), alcohol breath test or urine drug screen for substances of abuse. Positive tetrahydrocannabinol (THC) is not exclusionary. * A Screening thyroid stimulating hormone (TSH) level that is \<0.9 × lower limit normal (LLN) or ≥1.2 × ULN * Cortisol level \<1.0 × LLN (Collected in the AM at the Baseline Visit) Inclusion Criteria for RA Participants: * Adults of age 18 to 75 years, inclusive, at the time of signing the ICF. * BMI within the range of 18.0- to 35.0 kg/m² (inclusive). * Has RA for ≥6 months. * Positive rheumatoid factor (RF) or anti-citrullinated protein antibody (ACPA) test at Screening (low or high positive acceptable). * A high-sensitivity C-reactive protein (hsCRP) level at Screening must be \>ULN. * Has active RA disease defined as follows: * Disease Activity Score of 28 joints-CRP (DAS28-CRP) \>3.2 at Screening and Baseline * Has ≥4 swollen and ≥4 tender joints on a 28-joint count at Screening and Baseline * On MTX orally or subcutaneously for at least 12 weeks prior to Screening. Dose of MTX (including route of administration) must have been stable at 15 to 25 mg weekly (or 10 to15mg in case of documented intolerance) for ≥ 12weeks at Randomization with plans to continue it at the same dose and route of administration for the duration of the study. Exclusion Criteria for RA Participants: * Clinical evidence of significant unstable or uncontrolled acute or chronic diseases (e.g., cardiac \[including congestive heart failure, angina, or history of myocardial infarction\], pulmonary \[including chronic obstructive pulmonary disease, asthma requiring systemic GC therapy, pulmonary hypertension, or pulmonary fibrosis\], hematologic, gastrointestinal, hepatic, renal, neurological, psychiatric, dermatologic, musculoskeletal, or infectious diseases) that, in the opinion of the Investigator or Sponsor, constitutes an inappropriate risk or contraindication for participation in study or that could interfere with study objectives, conduct, or evaluation * Any other autoimmune or autoinflammatory disorder, which in the opinion of Investigator/Sponsor would constitute an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation. * Recent serious or ongoing infection, or risk for serious infection, or acute or chronic infection * Known seropositivity for or active infection by HIV or strongyloides (if at risk of exposure (e.g., travel from/reside in endemic area)) * Active or latent TB infection, as suggested by a positive chest radiograph OR positive/indeterminate QFT-TB Gold Plus or T-SPOT within the 12 weeks prior to Screening or a positive Screening CXR or QFT test. Indeterminate screening QFT tests are also exclusionary but may be repeated once and will be considered positive if retest results are positive or indeterminate/borderline. * Clinically significant abnormalities on ECG per the Investigator or Sponsor or any of the following mean ECG parameters on screening/baseline (triplicate) ECG: * HR \<40 or \>100 beats per minute * QTcF (Fridericia corrected QT) interval \>450 ms (males) or \>470 ms (females) * QRS interval \>120 ms * PR interval \>220 ms * Use or anticipated use of medications for the timeframes specified below: * Unstable use of any herbal medicines (e.g., St. John's wort) and supplements within 4 weeks prior to Screening through Baseline or anticipated changes in use during study. * Systemic or local (e.g., topical, oral, ophthalmic) corticosteroid (CS) use within 6 weeks prior to randomization or anticipated use during the study (other than as study intervention). * Any intra-articular injection within 4 weeks prior to Screening through Baseline or anticipated use during the study. * Use of cyclophosphamide, chlorambucil, leflunomide for \<6 months or cyclosporine, mycophenolic acid, azathioprine, tacrolimus, or gold \<8 weeks prior to Screening through Baseline or anticipated use during the study. * Receipt of rituximab or any other cell depleting biologic therapy within 1 year of Screening through Baseline or anticipated use during the study. * Use of any other commercial injectable biologic (including those for other non- arthritic conditions such as asthma, osteoporosis, lipids, atopic dermatitis) within 12 weeks or 5 half-lives (whichever is longer) prior to Screening through Baseline, or anticipated use during the study. * Use of any other oral DMARD, including JAK-inhibitors, within 12 weeks prior to Screening through Baseline or anticipated used during the study. MTX or HCQ use is permitted as specified in the Inclusion Criteria * Use of \>1 systemic biologic therapy for the treatment of RA prior to Screening or Baseline. For those participants that have used no more than one systemic biologic therapy, the systemic biologic therapy must have been discontinued at least 12 weeks or 5 half-lives (whichever is longer) prior to Screening with no use through Baseline or anticipated use during the study. * Receiving or has received any investigational drug (or is currently using an investigational device) within 30 days or 5 half-lives (whichever is longer), prior to Screening. * Unstable use of topical or systemic nonsteroidal anti-inflammatory drugs (NSAIDs) OR use above the maximum allowed doses OR use of more than 1 systemic NSAID (other than prophylactic aspirin ≤325mg daily) in the 2 weeks prior to Screening through Baseline or anticipated use during the study. * The presence at Screening of any laboratory values of concern in the opinion of the Investigator or Sponsor or of any of the below based on central laboratory testing at Screening: * WBC count \<3.0 × 10⁹/L * ANC \<2.0 × 10⁹/L * Hgb \<10 g/dL * Platelet count \<100 × 10⁹/L * ALT \>2 × ULN * Total bilirubin ≥1.5 × ULN (unless Gilbert's disease is suspected) * eGFR \<45 mL/min/1.73m² estimated based on CKD-EPI 2021 formula * International normalized ratio \>1.2 × ULN * HbA1c \>8% * AM cortisol level at Baseline Visit \<0.9 × LLN * Positive alcohol breath test or urine drug screen for substances of abuse. Positive THC or positivity for other substances due to ongoing use of these drugs under physician supervision (e.g., prescription narcotics for known pain disorder) are not exclusionary. * A Screening TSH level that is \<0.9 × LLN or \> 1.1 × ULN.

Treatments Being Tested

DRUG

LFD-200

2 mL glass vials, as 150 mg/mL concentrated solution

OTHER

Placebo

0.9% NaCl

DRUG

Oral Prednisone

Tablet

OTHER

Placebo

Placebo tablet to match Prednisone

Locations (6)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Nucleus Network
Melbourne, Australia
Arensia Exploratory Medicine LLC
Tbilisi, Georgia
Clinical Republican Hospital "Timofei Mosneaga", ARENSIA E.M.
Chisinau, Moldova
MICS Centrum Medyczne Torun - MICS - PPDS
Torun, Poland
Centrum Medyczne Reuma Park
Warsaw, Poland
"ARENSIA EXPLORATORY MEDICINE" LIMITED LIABILITY COMPANY, Medical Center, Department of Clinical Trials
Kyiv, Ukraine

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07207954), the sponsor (Lifordi Immunotherapeutics, Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07207954 clinical trial studying?

This is a double-blind, randomized, placebo- and active-controlled study investigating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous (SC) doses of LFD-200. The study design includes: a single ascending dose (SAD) study in up to 66 adult healthy participants (HPs) to investigate the effects of a single SC dose, with a 30-day follow-up; a multiple ascending dose (MAD) study in up to 40 HPs to assess up to 4 weekly SC doses, with a 30-day follow-up after the last dose; and a MAD study in up to 70 participants with moderate to severe rheumatoid arthriti… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07207954?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07207954?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07207954. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07207954. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.