RecruitingPhase 1NCT07207954

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

Sponsor

Lifordi Immunotherapeutics, Inc.

Enrollment

176 participants

Start Date

Oct 6, 2025

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called LFD-200 in both healthy people and in adults with moderate to severe rheumatoid arthritis — a condition where the immune system attacks the joints, causing pain, swelling, and stiffness. **You may be eligible if (healthy participants)...** - You are 18–55 years old with a BMI between 18 and 32 - You are generally healthy with no significant medical history **You may be eligible if (rheumatoid arthritis participants)...** - You have a confirmed diagnosis of moderate to severe rheumatoid arthritis - Your disease meets specific activity thresholds at screening **You may NOT be eligible if...** - You have a recent or ongoing serious infection - You have a known immune deficiency - You have any illness that could interfere with study results or put you at risk - You have had certain vaccinations or medical treatments recently (as determined by the study team) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLFD-200

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

OTHERPlacebo

0.9% NaCl

DRUGOral Prednisone

Tablet

OTHERPlacebo

Placebo tablet to match Prednisone

Locations(6)

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

View Full Details on ClinicalTrials.gov

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NCT07207954

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