Regeneron Research Facility
Ghent, B-9000, Belgium
NCT Number: NCT03645746
The primary objective of the study is to evaluate the safety and tolerability of single ascending doses of REGN5069 administered intravenously (IV) and subcutaneously (SC) in healthy male and female participants.
The secondary objectives of the study are to characterize the pharmacokinetics (PK) profile of single IV and SC doses of REGN5069 in healthy participants and assess the immunogenicity of REGN5069 in healthy participants administered single IV or SC doses of REGN5069
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Ghent, B-9000, 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 Inclusion/Exclusion Criteria apply
REGN5069 will be administered by IV infusion or SC injection
Placebo-matching REGN5069
Time frame: From baseline up to week 36
Time frame: From baseline up to week 36
As measured by chemistry, hematology and urinalysis
Time frame: From baseline up to week 36
As measured by heart rate, blood pressure, body temperature and respiratory rate
Time frame: From baseline up to week 36
As measured by heart rate, PR, complex of Q, R, and S waves [QRS], QT-intervals, and QTc
Time frame: From baseline up to week 36
Time frame: From baseline up to week 36
Regeneron Pharmaceuticals
Industry
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN5069 in Healthy Volunteers
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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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