NCT07207954

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: Lifordi Immunotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-10-06
• Primary completion: 2027-07-16
• Completion: 2027-07-16
• First posted: 2025-10-06
• Last updated: 2026-03-23

Locations

6 sites across 5 countries: Australia, Georgia, Moldova, Poland, Ukraine