Regeneron Study Site
Antwerp, B-2060, Belgium
NCT Number: NCT04491838
The primary objective of the study is to compare the pharmacokinetic(PK) profile of pozelimab produced by the original manufacturing process (Process A) compared to a second manufacturing process (Process B)
The secondary objectives of the study are:
* Assess the safety and tolerability of a single SC dose of pozelimab produced by the 2 manufacturing processes * Assess the immunogenicity of pozelimab produced by the 2 manufacturing processes
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Antwerp, B-2060, 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
Single subcutaneous (SC) injection
Other names: REGN3918
Time frame: Up to 16 weeks
Time frame: Up to 16 weeks
Time frame: Up to 16 weeks
Time frame: Up to 16 weeks
Time frame: Up to 16 weeks
Time frame: Up to 16 weeks
Regeneron Pharmaceuticals
Industry
A Randomized, Open-Label, Parallel Group Study of the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of Pozelimab Produced From Two Different Manufacturing Processes in Healthy Subjects
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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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