Covance Clinical Research Unit (CRU) Ltd.
Leeds, LS2 9LH, United Kingdom
NCT Number: NCT03115996
To evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses and a multiple dose regimen.
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Notify Me18 year–50 year
All sexes
Interventional
Phase 1
Leeds, LS2 9LH, United Kingdom
Participants will be randomized to single IV or SC or multiple dose treatment with REGN3918 or matched placebo.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
A subject must meet the follow criteria to be eligible for inclusion in the study:
Key Exclusion Criteria:
A subject who meets any of the following criteria will be excluded from the study:
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Intravenous (IV) or Subcutaneous (SC)
Matching Placebo
Time frame: Up to 20 weeks
Time frame: Up to 20 weeks
Time frame: Up to 20 weeks
Assessed via serum concentrations of REGN3918 over time; Area under the Curve (AUC)
Time frame: Up to 20 weeks
Assessed via serum concentrations of REGN3918 over time; peak concentration Cmax
Time frame: Up to 20 weeks
Assessed by CH50 assay over time
Time frame: Up to 20 weeks
Peak concentration Cmax
Time frame: Up to 20 weeks
Assessed by measurement of anti-drug antibodies (ADA)
Regeneron Pharmaceuticals
Industry
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously and Subcutaneously Administered Human Monoclonal Antibody REGN3918 in Healthy Volunteers.
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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