NCT04532125

SAD and MAD Study With IV and SC Doses of ARGX-117

First-In-Human, Randomized, Double-Blinded, Placebo-Controlled Trial in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Intravenous and Subcutaneous Doses of ARGX-117 Co-mixed With rHuPH20

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1, first-in-human, double-blinded, randomized, placebo-controlled, escalating single and multiple dose levels trial to evaluate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ARGX-117 administered IV and/or SC. Up to 112 healthy, adult male and female subjects of non-childbearing potential will be enrolled in this trial.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	ARGX-117	Subjects treated with ARGX-117
OTHER	Placebo	Subjects treated with placebo
BIOLOGICAL	ARGX-117 + rHuPH20	Subjects treated with ARGX-117 + rHuPH20
OTHER	placebo + rHuPH20	Subjects treated with placebo + rHuPH20
BIOLOGICAL	ARGX-117 PH20 SC	Subjects treated with ARGX-117 PH20 SC
OTHER	Placebo PH20 SC	Subjects treated with placebo PH20 SC

Timeline

• Start date: 2020-08-03
• Primary completion: 2022-08-26
• Completion: 2022-08-26
• First posted: 2020-08-31
• Last updated: 2022-09-21

Locations

1 site across 1 country: Netherlands