Is a
Clinical Study attributes
NCT Number
Trial Recruitment Size
1100
Trial Sponsor
Clinical Trial Start Date
August 3, 2020
0Primary Completion Date
August 26, 2022
0Study Completion Date
August 26, 2022
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Other0
Intervention Type
Biological0
Other0
Intervention Name
ARGX-117 + rHuPH200
placebo + rHuPH200
Placebo PH20 SC0
Placebo0
ARGX-117 PH20 SC0
ARGX-1170
Interventional Trial Phase
Phase 10
Official Name
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 rHuPH200
Last Updated
September 21, 2022
0Allocation Type
Randomized0
Intervention Model
Sequential Assignment0
Masking Type
Quadruple0
Masked Party
Investigator0
Outcomes Assessor0
Participant0
Care Provider0
Study 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.
Timeline
No Timeline data yet.
Further Resources
No Further Resources data yet.
