A Phase 1a/1b, Randomized, Double-Blind, Placebo- and Active-Controlled, Single and Multiple Ascending Dose Study Evaluating the Comparative Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LFD-200 in Adult Participants Who Are Healthy or Have Moderate to Severe Rheumatoid Arthritis

Official 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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: TRIPLE
• Enrollment: 176 participants

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

Primary Outcomes

• Incidence of Adverse Events (AEs) (Baseline up to 30 days after last dose.)
• Severity of Adverse Events (AEs) (Baseline up to 30 days after last dose.)
• Seriousness of Adverse Events (AEs) (Baseline up to 30 days after last dose.)
• Change from Baseline in Blood Pressure (BP) (Baseline up to 30 days after last dose.)
• Change from Baseline in Temperature (Baseline up to 30 days after last dose.)

Secondary Outcomes

• 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.)

Trial Locations

• 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
• Centrum Medyczne Reuma Park, Warsaw, Poland
• "ARENSIA EXPLORATORY MEDICINE" LIMITED LIABILITY COMPANY, Medical Center, Department of Clinical Trials, Kyiv, Ukraine

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