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First received: December 20, 2022

Clinical Trial: A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX-119 in Healthy Participants

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Healthy Volunteers

Study Type: INTERVENTIONAL


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 Heal

Brief Summary: 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…

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