RecruitingPhase 1

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

Australia, Georgia, Moldova176 participantsStarted 2025-10-06

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Adverse Events (AEs)

Timeframe: Baseline up to 30 days after last dose.

Severity of Adverse Events (AEs)

Timeframe: Baseline up to 30 days after last dose.

Seriousness of Adverse Events (AEs)

Timeframe: Baseline up to 30 days after last dose.

Change from Baseline in Blood Pressure (BP)

Timeframe: Baseline up to 30 days after last dose.

Change from Baseline in Temperature

Timeframe: Baseline up to 30 days after last dose.

Change from Baseline in Respiratory Rate

Timeframe: Baseline up to 30 days after last dose.

Change from Baseline in Heart Rate (HR)

Timeframe: Baseline up to 30 days after last dose.

Trial details

NCT IDNCT07207954

SponsorLifordi Immunotherapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07-16

Contact for this trial

Matthew McClure, MD

+14158107700 mmcclure@lifordi.com

View on ClinicalTrials.gov More Rheumatoid Arthritis trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence of Adverse Events (AEs)

Timeframe: Baseline up to 30 days after last dose.

Severity of Adverse Events (AEs)

Timeframe: Baseline up to 30 days after last dose.

Seriousness of Adverse Events (AEs)

Timeframe: Baseline up to 30 days after last dose.

Change from Baseline in Blood Pressure (BP)

Timeframe: Baseline up to 30 days after last dose.

Change from Baseline in Temperature

Timeframe: Baseline up to 30 days after last dose.

Change from Baseline in Respiratory Rate

Timeframe: Baseline up to 30 days after last dose.

Change from Baseline in Heart Rate (HR)

Timeframe: Baseline up to 30 days after last dose.