NCT05288829

A Study of a Single Subcutaneous Dose of ALXN1210 in Healthy Adult Participants

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of a Single Dose of ALXN1210 Administered Subcutaneously Compared to Intravenously in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study evaluated the safety and tolerability of a single dose of ALXN1210 subcutaneous (SC) compared to ALXN1210 intravenous (IV) in healthy participants and to determine the absolute bioavailability of ALXN1210 SC.

Detailed description

The participants were randomly assigned in a 2:1 ratio to Cohort 1a in a blinded fashion to receive either a single dose of ALXN1210 SC 400 mg or single dose of placebo SC. The Safety Review Committee (SRC) evaluated the first 48 hours of postdose clinical safety data for participants in Cohort 1a to determine if enrollment into Cohorts 1b or 2 could begin. Following the SRC review, participants were randomly assigned in a 2:1 ratio to either Cohort 1b or Cohort 2. Within Cohort 1b, participants were blinded and further randomly assigned in a 5:1 ratio to receive either a single dose of ALXN1210 SC 400 mg or a single dose of placebo SC, respectively. The participants in Cohort 2 received a single dose of ALXN1210 IV 400 mg in an open-label fashion. Safety, PK, PD, and immunogenicity assessments were performed on the follow-up period after the last dose.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ALXN1210 SC	All doses of ALXN1210 SC were administered by four 100-milligram (mg) SC injections of 1 milliliter (mL) each in the abdominal area. All four 1-mL injections were administered over a 15-minute period with at least 15 minutes between the end of injection in 1 participant and the start of injection in the next participant.
DRUG	ALXN1210 IV	All doses of ALXN1210 IV were administered by IV infusion, using IV sets with in-line filters, at a maximum rate of 333 mL/hour, excluding interruption for safety or technical reason. There were at least 15 minutes between the end-of-infusion/injection in 1 participant and the start-of infusion/injection in the next participant.
DRUG	Placebo	All doses of placebo SC were administered by four 100-mg SC injections of 1 mL each in the abdominal area. All four 1-mL injections were administered over a 15-minute period with at least 15 minutes between the end of injection in 1 participant and the start of injection in the next participant.

Timeline

• Start date: 2016-08-19
• Primary completion: 2017-07-18
• Completion: 2017-07-18
• First posted: 2022-03-21
• Last updated: 2023-05-01
• Results posted: 2023-05-01

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study