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

NCT07207954 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2026-03-23

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Lifordi Immunotherapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-06
Primary Completion
2027-07-16
Completion
2027-07-16

Countries

  • Australia
  • Georgia
  • Moldova
  • Poland
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07207954 on ClinicalTrials.gov