drugset / Trial / NCT05670704

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

NCT05670704 ↗

Phase 1 Completed 112 enrolled argenx
RandomizedParallel-groupQuadruple-blindOther

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 IV doses of ARGX-119 (or placebo IV) will be administered in up to 5 cohorts.

Timeline

Start
2023-02-21
Primary completion
2024-08-08
Completion
2024-08-08

Drugs

EvaluationDrugModalityDoseRoute
Subject ARGX-119 Monoclonal antibody — Intravenous

Indications

No indication recorded.