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

StatusRecruiting
PhasePhase 1
Started

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Record History

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  1. Trial sites expanded: 7 → 10 locations
    • Eligibility criteria expanded, about 2 words
  2. Study sites: 6 to 7v4
  3. Study sites revised (6)v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 7 to 6
    v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07207954
Lead Sponsor Lifordi Immunotherapeutics, Inc.
Conditions
(from sponsor)		 Rheumatoid Arthritis
Related terms Arthritis, Rheumatoid
Enrollment 176 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov