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.
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.
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
Parallel
LFD-200
Drug2 mL glass vials, as 150 mg/mL concentrated solution
Placebo
Other intervention0.9% NaCl
Oral Prednisone
DrugTablet
Placebo
Other interventionPlacebo tablet to match Prednisone
Incidence of Adverse Events (AEs)
Number of participants experiencing any adverse events during the study period.
Severity of Adverse Events (AEs)
Classification of adverse events based on severity (mild, moderate, severe).
Seriousness of Adverse Events (AEs)
Number of participants experiencing serious adverse events (SAEs) during the study period.
Change from Baseline in Blood Pressure (BP)
Difference in systolic and diastolic blood pressure measurements from baseline to specified time points.
Maximum Observed Plasma Concentration (Cmax)
The highest concentration of the drug observed in plasma after administration.
Trough Concentration (Ctrough)
The lowest concentration of the drug observed in plasma before the next dose.
Average Concentration (Cavg)
The average concentration of the drug in plasma over a specified time period
Clearance
The rate at which the drug is removed from the body.
Click on the lead sponsor to view all of their trials.