Study of LFD-200 in Healthy Adults and Adults With Moderate to Severe Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Interventions
- Registration Number
- NCT07207954
- Lead Sponsor
- Lifordi Immunotherapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 176
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: SAD in HP LFD-200 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. Part 1: SAD in HP Placebo 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. Part 1: SAD in HP Oral Prednisone 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. Part 1: MAD in HP LFD-200 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. Part 1: MAD in HP Placebo 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. Part 2: MAD in RA LFD-200 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) Part 2: MAD in RA Placebo 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) Part 2: MAD in RA Oral Prednisone 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)
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs) Baseline up to 30 days after last dose. Number of participants experiencing any adverse events during the study period.
Severity of Adverse Events (AEs) Baseline up to 30 days after last dose. Classification of adverse events based on severity (mild, moderate, severe).
Seriousness of Adverse Events (AEs) Baseline up to 30 days after last dose. Number of participants experiencing serious adverse events (SAEs) during the study period.
Change from Baseline in Blood Pressure (BP) Baseline up to 30 days after last dose. Difference in systolic and diastolic blood pressure measurements from baseline to specified time points.
Change from Baseline in Temperature Baseline up to 30 days after last dose. Difference in body temperature measurements from baseline to specified time points.
Change from Baseline in Respiratory Rate Baseline up to 30 days after last dose. Difference in respiratory rate measurements from baseline to specified time points.
Change from Baseline in Heart Rate (HR) Baseline up to 30 days after last dose. Difference in heart rate measurements from baseline to specified time points.
Change in Hemeglobin from Baseline to specified timepoints Baseline up to 30 days after last dose. Hemeglobin is measured in g/dL
Change in Alanine Aminotransferase from Baseline to specified timepoints Baseline up to 30 days after last dose. Alanine Aminotransferase is measured in U/L
Change in Leukocytes in urine from Baseline to specified timepoints Baseline up to 30 days after last dose. Leukocytes in urine is measured in x10\^6/L
Change in Heart Rate (HR) from Baseline to specified timepoints Baseline up to 30 days after last dose. Heart rate is measured in beats per minute
Change from Baseline in PR Interval Baseline up to 30 days after last dose. Difference in PR interval measurements from baseline to specified time points.
Change from Baseline in QRS Interval Baseline up to 30 days after last dose. Difference in QRS interval measurements from baseline to specified time points.
Change from Baseline in QT Interval Baseline up to 30 days after last dose. Difference in QT interval measurements from baseline to specified time points.
Primary Outcome Measure: Change from Baseline in QTcF Interval Baseline up to 30 days after last dose. Difference in QTcF interval measurements from baseline to specified time points.
Incidence of Clinical Findings on Physical Examination Baseline up to 30 days after last dose. Number of participants with clinical findings during physical examinations, including injection site reactions.
Severity of Clinical Findings on Physical Examination Baseline up to 30 days after last dose. Classification of clinical findings based on severity (mild, moderate, severe), including injection site reactions.
- Secondary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) Baseline up to 30 days after last dose. The highest concentration of the drug observed in plasma after administration.
Trough Concentration (Ctrough) Baseline up to 30 days after last dose. The lowest concentration of the drug observed in plasma before the next dose.
Average Concentration (Cavg) Baseline up to 30 days after last dose. The average concentration of the drug in plasma over a specified time period
Clearance Baseline up to 30 days after last dose. The rate at which the drug is removed from the body.
Volume of Distribution Baseline up to 30 days after last dose. The volume in which the drug is distributed in the body.
Area Under the Plasma Concentration vs. Time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) Baseline up to 30 days after last dose. The area under the plasma concentration-time curve from the time of dosing to the last measurable concentration.
Area Under the Plasma Concentration vs. Time Curve from Time Zero Extrapolated to Infinity (AUCinf) Baseline up to 30 days after last dose. The area under the plasma concentration-time curve from the time of dosing extrapolated to infinity.
Area Under the Plasma Concentration vs. Time Curve from Time Zero to 168 Hours Post-Dose (AUC0-168) Baseline up to 30 days after last dose. The area under the plasma concentration-time curve from the time of dosing to 168 hours post-dose.
Area Under the Plasma Concentration vs Time Curve Over the Dosing Interval (AUCtau) Baseline up to 30 days after last dose. The area under the plasma concentration-time curve over the dosing interval.
Accumulation Ratio (Rac) Baseline up to 30 days after last dose. The ratio of drug accumulation in plasma after multiple dosing compared to a single dose.
Time Corresponding to the Maximum Observed Plasma Concentration (Tmax) Baseline up to 30 days after last dose. The time at which the maximum plasma concentration of the drug is observed.
Change from Baseline in Cortisol Levels Baseline up to 30 days after last dose. Difference in cortisol levels from baseline to specified time points.
Change from Baseline in Bone Biomarkers Baseline up to 30 days after last dose. Difference in Bone Biomarker levels from baseline to specified time points
Change from Baseline in DAS28-CRP Baseline up to 30 days after last dose. Difference in Disease Activity Score 28 - C-reactive protein (DAS28-CRP) from baseline to specified time points for rheumatoid arthritis (RA) cohorts.
Trial Locations
- Locations (7)
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
National Institute of Geriatrics, Rheumatology and Rehabilitation, Warsaw, Poland
🇵🇱Warsaw, Poland
Centrum Medyczne Reuma Park
🇵🇱Warsaw, Poland
"ARENSIA EXPLORATORY MEDICINE" LIMITED LIABILITY COMPANY, Medical Center, Department of Clinical Trials
🇺🇦Kyiv, Ukraine
Nucleus Network🇦🇺Melbourne, Australia