Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT07207954

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

Led by Lifordi Immunotherapeutics, Inc. · Updated on 2026-03-23

176

Participants Needed

6

Research Sites

92 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy participants aged 18 to 55 years with BMI 18-32
  • Generally healthy by medical evaluation including physical exam, medical history, vital signs, and labs
  • Adults aged 18 to 75 years with rheumatoid arthritis (RA) for 6 months or more
  • RA participants with positive rheumatoid factor or anti-citrullinated protein antibody test
  • RA participants with high-sensitivity C-reactive protein above upper limit of normal
  • RA participants with active disease defined by DAS28-CRP greater than 3.2 and at least 4 swollen and 4 tender joints
  • RA participants on stable methotrexate (MTX) dose for at least 12 weeks planning to continue during study
Not Eligible

You will not qualify if you...

  • Participants with current or previous illnesses that may affect study results or pose risks
  • Recent serious or ongoing infections or risk for serious infection
  • Known or suspected primary immunodeficiency
  • Use of injected or systemic glucocorticoids within 6 weeks before screening
  • Use of prohibited medications such as certain biologics, DMARDs, and unstable herbal supplements
  • Abnormal lab values including low blood counts, elevated liver enzymes, abnormal kidney function, abnormal coagulation, or abnormal thyroid or cortisol levels
  • Positive drug or alcohol tests (except THC positivity under physician supervision)
  • Unstable or uncontrolled acute or chronic diseases including cardiac, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, psychiatric, dermatologic, musculoskeletal, or infectious diseases
  • Other autoimmune or autoinflammatory disorders that interfere with study
  • Positive tests for HIV, tuberculosis, or strongyloides (if at risk)
  • Clinically significant ECG abnormalities
  • Use or anticipated use of systemic corticosteroids, intra-articular injections, certain immunosuppressive drugs, or investigational drugs within specified timeframes prior to or during study
  • Unstable or excessive use of NSAIDs
  • Laboratory abnormalities of concern as determined by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 6 locations

1

Nucleus Network

Melbourne, Australia, 3004

Actively Recruiting

2

Arensia Exploratory Medicine LLC

Tbilisi, Georgia, 112

Actively Recruiting

3

Clinical Republican Hospital "Timofei Mosneaga", ARENSIA E.M.

Chisinau, Moldova, MD2025

Actively Recruiting

4

MICS Centrum Medyczne Torun - MICS - PPDS

Torun, Poland, 87-100

Not Yet Recruiting

5

Centrum Medyczne Reuma Park

Warsaw, Poland, 02-691

Not Yet Recruiting

6

"ARENSIA EXPLORATORY MEDICINE" LIMITED LIABILITY COMPANY, Medical Center, Department of Clinical Trials

Kyiv, Ukraine, 1135

Actively Recruiting

Loading map...

Research Team

M

Matthew McClure, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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