Regeneron Study Site
Edegem, Antwerp, B-2650, Belgium
NCT Number: NCT05102136
The primary objective of the study is to evaluate the safety and tolerability of single doses of REGN9933 in healthy participants
The secondary objectives of the study are to:
* Evaluate the effects of single doses of REGN9933 on intrinsic/common pathway coagulation * Evaluate the effects of single doses of REGN9933 on extrinsic/common pathway coagulation * Characterize the drug concentration profiles and pharmacokinetic (PK) following single escalating doses of REGN9933 * Characterize the concentration profiles of total FXI following single escalating doses of REGN9933 * Assess the immunogenicity of single doses of REGN9933
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Edegem, Antwerp, B-2650, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined inclusion/exclusion criteria apply.
Administered intravenously (IV) or subcutaneous (SC) per the protocol
Placebo to match REGN9933 in same form; placebo administered IV or SC per the protocol
Time frame: Until resolution of pharmacodynamic (PD) effects; approximately 36 days
Time frame: Until resolution of PD effects; approximately 36 days
Time frame: Until resolution of PD effects; approximately 36 days
Time frame: Until resolution of PD effects; approximately 36 days
Time frame: Until resolution of PD effects; approximately 36 days
Time frame: Until resolution of PD effects; approximately 36 days
Regeneron Pharmaceuticals
Industry
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of REGN9933, a Monoclonal Antibody Against Factor XI, in Healthy Adult Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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