Healthy Volunteers Clinical Trial
Official title:
A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX-119 in Healthy Participants
This phase 1 study is an FIH, double-blinded, placebo-controlled study investigating the safety, tolerability, PK, and immunogenicity of ARGX 119 administered as single doses (IV or SC) or multiple doses (IV) to healthy participants. The study IMPs are ARGX-119 or placebo for IV or SC administration. This study will include 2 parts: - In part A, ARGX-119 IV (or placebo IV) will be administered to 9 cohorts as single doses , while ARGX-119 SC (or placebo SC) will be administered to a 10th cohort. - In part B, 4 once-weekly IV doses of ARGX-119 (or placebo IV) will be administered in up to 5 cohorts.
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