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

NCT07207954 | Recruiting Phase 1

• 1 other identifier: LFD200A11
• Study Type: interventional
• Target: 176
• Locations: 5 countries
• Sites: 6

Brief 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

Keywords

RA; Rheumatoid Arthritis; Healthy Participants; Phase 1a/1b; Safety; Tolerability; Pharmacokinetics; Pharmacodynamics; First in human; Single Ascending Dose; Multiple Ascending Dose

Outcome Measures

Primary Outcomes (17)

• Incidence of Adverse Events (AEs)

  Number of participants experiencing any adverse events during the study period.

  Baseline up to 30 days after last dose.

• Severity of Adverse Events (AEs)

  Classification of adverse events based on severity (mild, moderate, severe).

  Baseline up to 30 days after last dose.

• Seriousness of Adverse Events (AEs)

  Number of participants experiencing serious adverse events (SAEs) during the study period.

  Baseline up to 30 days after last dose.

• Change from Baseline in Blood Pressure (BP)

  Difference in systolic and diastolic blood pressure measurements from baseline to specified time points.

  Baseline up to 30 days after last dose.

• Change from Baseline in Temperature

  Difference in body temperature measurements from baseline to specified time points.

  Baseline up to 30 days after last dose.

• Change from Baseline in Respiratory Rate

  Difference in respiratory rate measurements from baseline to specified time points.

  Baseline up to 30 days after last dose.

• Change from Baseline in Heart Rate (HR)

  Difference in heart rate measurements from baseline to specified time points.

  Baseline up to 30 days after last dose.

• Change in Hemeglobin from Baseline to specified timepoints

  Hemeglobin is measured in g/dL

  Baseline up to 30 days after last dose.

• Change in Alanine Aminotransferase from Baseline to specified timepoints

  Alanine Aminotransferase is measured in U/L

  Baseline up to 30 days after last dose.

• Change in Leukocytes in urine from Baseline to specified timepoints

  Leukocytes in urine is measured in x10\^6/L

  Baseline up to 30 days after last dose.

• Change in Heart Rate (HR) from Baseline to specified timepoints

  Heart rate is measured in beats per minute

  Baseline up to 30 days after last dose.

• Change from Baseline in PR Interval

  Difference in PR interval measurements from baseline to specified time points.

  Baseline up to 30 days after last dose.

• Change from Baseline in QRS Interval

  Difference in QRS interval measurements from baseline to specified time points.

  Baseline up to 30 days after last dose.

• Change from Baseline in QT Interval

  Difference in QT interval measurements from baseline to specified time points.

  Baseline up to 30 days after last dose.

• Primary Outcome Measure: Change from Baseline in QTcF Interval

  Difference in QTcF interval measurements from baseline to specified time points.

  Baseline up to 30 days after last dose.

• Incidence of Clinical Findings on Physical Examination

  Number of participants with clinical findings during physical examinations, including injection site reactions.

  Baseline up to 30 days after last dose.

• Severity of Clinical Findings on Physical Examination

  Classification of clinical findings based on severity (mild, moderate, severe), including injection site reactions.

  Baseline up to 30 days after last dose.

Secondary Outcomes (14)

• Maximum Observed Plasma Concentration (Cmax)

  Baseline up to 30 days after last dose.

• Trough Concentration (Ctrough)

  Baseline up to 30 days after last dose.

• Average Concentration (Cavg)

  Baseline up to 30 days after last dose.

• Clearance

  Baseline up to 30 days after last dose.

• Volume of Distribution

  Baseline up to 30 days after last dose.

Study Arms (3)

Part 1: SAD in HP

EXPERIMENTAL

Three planned cohorts (SAD HP Cohorts 1 to 3) and 3 optional cohorts (SAD HP Cohorts 4 to-6) of 11 participants each will receive a single SC dose of LFD-200, a single SC dose of matching saline placebo, or a single oral dose of open label 10 mg prednisone. Within each cohort, 6 participants will be randomly assigned to receive LFD-200, 2 participants will receive saline placebo, and 3 will receive prednisone.

Drug: LFD-200; Other: Placebo; Drug: Oral Prednisone

Part 1: MAD in HP

EXPERIMENTAL

Two planned cohorts (MAD HP Cohorts 1 and 2) of 8 HPs each (16 total) will be randomly assigned to receive 4 weekly SC doses of LFD-200 (6 participants) or saline placebo (2 participants) over a duration of 22 days.

Drug: LFD-200; Other: Placebo

Part 2: MAD in RA

EXPERIMENTAL

Two planned cohorts (MAD RA Cohorts 1 and 2) of 14 RA participants each (28 total) will be randomly assigned to receive either up to 13 weekly SC doses of LFD-200 over 85 days with a daily prednisone placebo tablet (LFD-200 arm; 8 participants), or up to 13 weekly SC doses of saline placebo over 85 days with daily prednisone placebo tablet (placebo arm; 3 participants), or up to 13 weekly SC doses of saline placebo over 85 days with a daily dose of oral prednisone (prednisone arm; 3 participants)

Drug: LFD-200; Other: Placebo; Drug: Oral Prednisone

Interventions

LFD-200 DRUG

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

Part 1: MAD in HP; Part 1: SAD in HP; Part 2: MAD in RA

Placebo OTHER

0.9% NaCl

Part 1: MAD in HP; Part 1: SAD in HP; Part 2: MAD in RA

Oral Prednisone DRUG

Tablet

Part 1: SAD in HP; Part 2: MAD in RA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Glycated hemoglobin (HbA1c) \>6%

Sponsors & Collaborators

• Lifordi Immunotherapeutics, Inc.: lead

Study Sites (6)

Nucleus Network

Melbourne, 3004, Australia

RECRUITING

Arensia Exploratory Medicine LLC

Tbilisi, 112, Georgia

RECRUITING

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

Chisinau, MD2025, Moldova

RECRUITING

MICS Centrum Medyczne Torun - MICS - PPDS

Torun, 87-100, Poland

NOT YET RECRUITING

Centrum Medyczne Reuma Park

Warsaw, 02-691, Poland

NOT YET RECRUITING

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

Kyiv, 1135, Ukraine

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Matthew McClure, MD

CONTACT

+14158107700; mmcclure@lifordi.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: October 6, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): July 16, 2027
• Study Completion (Estimated): July 16, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); PL (2); UA (1); GE (1); MO (1)