NCT04920370

Study of Subcutaneous and Intravenous ALXN1720 With and Without rHuPH20 in Healthy Subjects

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study of Subcutaneous and Intravenous ALXN1720 With and Without rHuPH20 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1720 administered subcutaneously (SC) or intravenously (IV).

Detailed description

Participants will be randomized in a 3:1 ratio to receive the active treatment or placebo. The study will be conducted in healthy adult participants, including participants of Japanese descent.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ALXN1720 SC	ALXN1720 will be administered via SC route.
DRUG	ALXN1720 IV	ALXN1720 will be administered via IV route.
DRUG	rHuPH20	rHuPH20 will be administered via SC route.
DRUG	Placebo SC	Placebo will be administered via SC route.
DRUG	Placebo IV	Placebo will be administered via IV route.

Timeline

• Start date: 2019-09-04
• Primary completion: 2021-11-16
• Completion: 2021-11-16
• First posted: 2021-06-09
• Last updated: 2022-02-11

Locations

1 site across 1 country: United Kingdom