Regeneron Research Site
London, SE1 1YR, United Kingdom
NCT Number: NCT04940364
The primary objective of the study is to assess the concentration-time profiles of total pozelimab, total C5, cemdisiran, and cemdisiran metabolite(s) in Japanese adult participants following single doses of intravenous (IV) and subcutaneous (SC) pozelimab and SC cemdisiran when administered on the same day or sequentially 28 days apart.
The secondary objectives of the study are:
* To evaluate the safety and tolerability of pozelimab alone and in combination with cemdisiran in healthy Japanese adult participants * To assess the pharmacodynamic (PD) profile of pozelimab alone and in combination with cemdisiran in healthy Japanese adult participants * To assess the immunogenicity of pozelimab and cemdisiran in healthy Japanese adult participants
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
London, SE1 1YR, United Kingdom
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 and Exclusion criteria apply
Administered intravenous (IV) or subcutaneous (SC) per protocol
Other names: REGN3918
Administered SC per protocol
Other names: ALN-CC5
Time frame: Up to 20 weeks
Time frame: Up to 20 weeks
Time frame: Up to 20 weeks
Time frame: Up to 20 weeks
Time frame: Up to 20 weeks
Time frame: Up to 20 weeks
Time frame: Up to 20 weeks
Regeneron Pharmaceuticals
Industry
An Open-Label Parallel-Dose Study of the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Single Doses of Subcutaneously and Intravenously Administered Pozelimab as Monotherapy and in Combination With Single Doses of Subcutaneously Administered Cemdisiran in Japanese 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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