Trials / Completed
CompletedNCT03457649
IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers
A Phase I, Randomized, Double-Blind, Placebo-Controlled, SAD and MAD Intravenous Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of ARGX-113 in Healthy Males and Female Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- argenx · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
A phase 1 study in healthy volunteers (female and male) to evaluate through SAD and MAD, the safety, PK, PD and immunogenicity of ARGX-113 administered intravenously.
Detailed description
The phase 1 in healthy volunteers include: SAD with 5 doses of test product and placebo MAD with 2 doses and two dosing intervals of the test product and placebo The safety, pharmacokinetics, pharmacodynamics and immunogenicity of the test product are evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ARGX-113 | |
| BIOLOGICAL | Placebo |
Timeline
- Start date
- 2015-09-09
- Primary completion
- 2016-11-15
- Completion
- 2017-02-21
- First posted
- 2018-03-07
- Last updated
- 2024-05-23
Source: ClinicalTrials.gov record NCT03457649. Inclusion in this directory is not an endorsement.