IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT03457649 |
Recruitment Status :
Completed
First Posted : March 7, 2018
Last Update Posted : March 7, 2018
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Sponsor:
argenx
Information provided by (Responsible Party):
argenx
Tracking Information | |||||
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First Submitted Date ICMJE | February 9, 2018 | ||||
First Posted Date ICMJE | March 7, 2018 | ||||
Last Update Posted Date | March 7, 2018 | ||||
Actual Study Start Date ICMJE | September 9, 2015 | ||||
Actual Primary Completion Date | November 15, 2016 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Number of (related) treatment emergent AE of single ascending dose of ARGX-113 [ Time Frame: 57 days ] Determining the incidence, severity, and dose relationship of adverse events that are related to treatment with ARGX-113
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
Number of (related) treatment emergent AE of multiple ascending doses of ARGX-113 [ Time Frame: 78 days ] Determining the incidence, severity, and dose relationship of adverse events that are related to treatment with ARGX-113
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers | ||||
Official Title ICMJE | 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 | ||||
Brief 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Intervention Model Description: SAD MAD Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Other |
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Condition ICMJE | Healthy Volunteers | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Ulrichts P, Guglietta A, Dreier T, van Bragt T, Hanssens V, Hofman E, Vankerckhoven B, Verheesen P, Ongenae N, Lykhopiy V, Enriquez FJ, Cho J, Ober RJ, Ward ES, de Haard H, Leupin N. Neonatal Fc receptor antagonist efgartigimod safely and sustainably reduces IgGs in humans. J Clin Invest. 2018 Oct 1;128(10):4372-4386. doi: 10.1172/JCI97911. Epub 2018 Jul 24. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
62 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | February 21, 2017 | ||||
Actual Primary Completion Date | November 15, 2016 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: Subjects meeting all of the following criteria are eligible to participate in this study:
Exclusion Criteria: Subjects meeting any of the following criteria are excluded from participation in this study:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03457649 | ||||
Other Study ID Numbers ICMJE | ARGX-1501 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | argenx | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | argenx | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | argenx | ||||
Verification Date | February 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |