Phase 1 Safety and Tolerability Study of REGN9533 in Healthy Adults.
- Registration Number
- 2024-515285-14-00
- Lead Sponsor
- Regeneron Pharmaceuticals Inc.
- Brief Summary
The aim of this clinical trial is to see how safe and tolerable the clinical trial drug (REGN9533) is in healthy participants. This is the first time that REGN9533 will be given to humans.
After the clinical trial drug has been tested in healthy participants, future studies with REGN9533 will focus on participants with thromboembolic (blocking of blood vessels) diseases which include blood clots.
REGN9533 is a drug that is only used in clinical studies.
The clinical trial is looking at:
* The side effects REGN9533 might cause
* How much REGN9533 is in the blood at different times
* How the body reacts to REGN9533
* If the body makes antibodies to REGN9533 (unwanted immune response, which may cause REGN9533 to not work as well)
* What is the best dose of REGN9533
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 72
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description REGN9533 REGN9533 Randomized as described in the protocol Escalating Cohorts including Optional Cohorts Placebo Matching Placebo Randomized as described in the protocol
- Primary Outcome Measures
Name Time Method Incidence of Treatment Emergent Adverse Events (TEAEs) Up to 100 days Severity of TEAEs Up to 100 days
- Secondary Outcome Measures
Name Time Method Change in activated Partial Thromboplastin Time (aPTT) Baseline up to 100 days Change in Prothrombin Time (PT) Baseline up to 100 days Concentrations of REGN9533 Up to 100 days Incidence of Anti-drug Antibodies (ADAs) to REGN9533 Up to 100 days Titer of ADAs to REGN9533 Up to 100 days
Trial Locations
- Locations (1)
SGS Belgium
🇧🇪Edegem, Belgium
SGS Belgium🇧🇪Edegem, BelgiumFrédéric VanhoutteSite contact+320477790583Frederic.vanhoutte@sgs.com